A Clinical Proof-of-principle Trial in Adult Subjects With Newly Diagnosed Type 1 Diabetes Mellitus Investigating the Effect of NNC0114-0006 and Liraglutide on Preservation of Beta-cell Function

March 10, 2021 updated by: Novo Nordisk A/S

A Randomised, Double-blind, Double-dummy, Placebo-controlled, Parallel-group Multi-centre Clinical Proof-of-principle Trial in Adult Subjects With Newly Diagnosed Type 1 Diabetes Mellitus Investigating the Effect of NNC0114-0006 and Liraglutide on Preservation of Beta-cell Function

This trial is conducted globally. The aim of this trial is to assess the clinical proof-of-principle of NNC0114-0006 and liraglutide on preservation of beta-cell function in adult subjects with newly diagnosed type 1 diabetes mellitus.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
308

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8036
        • Novo Nordisk Investigational Site
      • Innsbruck, Austria, 6020
        • Novo Nordisk Investigational Site
      • Salzburg, Austria, 5020
        • Novo Nordisk Investigational Site
      • Wien, Austria, 1130
        • Novo Nordisk Investigational Site
      • Wien, Austria, 1030
        • Novo Nordisk Investigational Site
  • Belgium
      • Brussel, Belgium, 1090
        • Novo Nordisk Investigational Site
      • Edegem, Belgium, 2650
        • Novo Nordisk Investigational Site
      • Leuven, Belgium, 3000
        • Novo Nordisk Investigational Site
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2E1
        • Novo Nordisk Investigational Site
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Novo Nordisk Investigational Site
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 3P4
        • Novo Nordisk Investigational Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Novo Nordisk Investigational Site
    • Ontario
      • Kingston, Ontario, Canada, K7L 2V7
        • Novo Nordisk Investigational Site
      • Toronto, Ontario, Canada, M4G 3E8
        • Novo Nordisk Investigational Site
    • Quebec
      • Laval, Quebec, Canada, H7T 2P5
        • Novo Nordisk Investigational Site
      • Montreal, Quebec, Canada, H4A 3T2
        • Novo Nordisk Investigational Site
      • PQ, Quebec, Canada, G1L 3L5
        • Novo Nordisk Investigational Site
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Novo Nordisk Investigational Site
  • Denmark
      • Aarhus N, Denmark, 8200
        • Novo Nordisk Investigational Site
      • Esbjerg, Denmark, 6700
        • Novo Nordisk Investigational Site
      • Hellerup, Denmark, 2900
        • Novo Nordisk Investigational Site
  • Finland
      • Helsinki, Finland, 00290
        • Novo Nordisk Investigational Site
      • Oulu, Finland, 90220
        • Novo Nordisk Investigational Site
      • Tampere, Finland, 33520
        • Novo Nordisk Investigational Site
  • Ireland
      • Dublin, Ireland, DUBLIN 15
        • Novo Nordisk Investigational Site
      • Dublin, Ireland, DUBLIN 4
        • Novo Nordisk Investigational Site
      • Galway, Ireland, H91 YR71
        • Novo Nordisk Investigational Site
  • Israel
      • Holon, Israel, 58100
        • Novo Nordisk Investigational Site
      • Jerusalem, Israel, 91120
        • Novo Nordisk Investigational Site
      • Petah Tikva, Israel, 49202
        • Novo Nordisk Investigational Site
      • Rehovot, Israel, 76100
        • Novo Nordisk Investigational Site
  • Italy
      • Bergamo, Italy, 24127
        • Novo Nordisk Investigational Site
      • Catanzaro, Italy, 88100
        • Novo Nordisk Investigational Site
      • Milano, Italy, 20132
        • Novo Nordisk Investigational Site
      • Siena, Italy, 53100
        • Novo Nordisk Investigational Site
  • Norway
      • Oslo, Norway, 0586
        • Novo Nordisk Investigational Site
      • Stavanger, Norway, 4011
        • Novo Nordisk Investigational Site
  • Poland
      • Gdansk, Poland, 80-546
        • Novo Nordisk Investigational Site
      • Gdansk, Poland, 80-214
        • Novo Nordisk Investigational Site
      • Warszawa, Poland, 04-736
        • Novo Nordisk Investigational Site
      • Zabrze, Poland, 41-800
        • Novo Nordisk Investigational Site
  • Portugal
      • Almada, Portugal, 2805-267
        • Novo Nordisk Investigational Site
      • Amadora, Portugal, 2720-276
        • Novo Nordisk Investigational Site
      • Braga, Portugal, 4710-243
        • Novo Nordisk Investigational Site
      • Matosinhos, Portugal, 4464-513
        • Novo Nordisk Investigational Site
      • Porto, Portugal, 4200-319
        • Novo Nordisk Investigational Site
      • Viana do Castelo, Portugal, 4901-858
        • Novo Nordisk Investigational Site
  • Russian Federation
      • Arkhangelsk, Russian Federation, 163001
        • Novo Nordisk Investigational Site
      • Chelyabinsk, Russian Federation, 454048
        • Novo Nordisk Investigational Site
      • Dzerzhinskiy, Russian Federation, 140091
        • Novo Nordisk Investigational Site
      • Kazan, Russian Federation, 420012
        • Novo Nordisk Investigational Site
      • Moscow, Russian Federation, 123423
        • Novo Nordisk Investigational Site
      • Moscow, Russian Federation, 125315
        • Novo Nordisk Investigational Site
      • Novosibirsk, Russian Federation, 630091
        • Novo Nordisk Investigational Site
      • Penza, Russian Federation, 440026
        • Novo Nordisk Investigational Site
      • Saint-Petersburg, Russian Federation, 199226
        • Novo Nordisk Investigational Site
      • Saratov, Russian Federation, 410053
        • Novo Nordisk Investigational Site
      • Saratov, Russian Federation, 410031
        • Novo Nordisk Investigational Site
      • Syktyvkar, Russian Federation, 167981
        • Novo Nordisk Investigational Site
      • Ulianovsk, Russian Federation, 432063
        • Novo Nordisk Investigational Site
      • Yoshkar-Ola, Russian Federation, 424004
        • Novo Nordisk Investigational Site
  • Serbia
      • Belgrade, Serbia, 11000
        • Novo Nordisk Investigational Site
      • Kragujevac, Serbia, 34000
        • Novo Nordisk Investigational Site
  • Spain
      • Barcelona, Spain, 08035
        • Novo Nordisk Investigational Site
      • Girona, Spain, 17007
        • Novo Nordisk Investigational Site
      • Málaga, Spain, 29010
        • Novo Nordisk Investigational Site
      • Palma de Mallorca, Spain, 07198
        • Novo Nordisk Investigational Site
      • Sabadell, Spain, 08208
        • Novo Nordisk Investigational Site
      • Sevilla, Spain, 41003
        • Novo Nordisk Investigational Site
      • Sevilla, Spain, 41009
        • Novo Nordisk Investigational Site
      • Valencia, Spain, 46026
        • Novo Nordisk Investigational Site
  • Sweden
      • Göteborg, Sweden, 413 45
        • Novo Nordisk Investigational Site
      • Karlstad, Sweden, 651 85
        • Novo Nordisk Investigational Site
      • Lund, Sweden, 221 85
        • Novo Nordisk Investigational Site
      • Stockholm, Sweden, 141 86
        • Novo Nordisk Investigational Site
  • Ukraine
      • Kyiv, Ukraine, 03049
        • Novo Nordisk Investigational Site
      • Kyiv, Ukraine, 04053
        • Novo Nordisk Investigational Site
      • Kyiv, Ukraine, 02091
        • Novo Nordisk Investigational Site
      • Kyiv, Ukraine, 04114
        • Novo Nordisk Investigational Site
      • Kyiv, Ukraine, 02232
        • Novo Nordisk Investigational Site
      • Vinnytsia, Ukraine, 21010
        • Novo Nordisk Investigational Site
      • Zhytomyr, Ukraine, 10002
        • Novo Nordisk Investigational Site
  • United Kingdom
      • Belfast, United Kingdom, BT12 6BA
        • Novo Nordisk Investigational Site
      • Blackburn, United Kingdom, BB2 3HH
        • Novo Nordisk Investigational Site
      • Bristol, United Kingdom, BS10 5NB
        • Novo Nordisk Investigational Site
      • Cardiff, United Kingdom, CF14 4XW
        • Novo Nordisk Investigational Site
      • Chester, United Kingdom, CH2 1UL
        • Novo Nordisk Investigational Site
      • Edgbaston, Birmingham, United Kingdom, B15 2TH
        • Novo Nordisk Investigational Site
      • London, United Kingdom, E1 2AT
        • Novo Nordisk Investigational Site
      • London, United Kingdom, W2 1NY
        • Novo Nordisk Investigational Site
      • Newcastle upon Tyne, United Kingdom, NE1 4LP
        • Novo Nordisk Investigational Site
      • Plymouth, United Kingdom, PL8 8DQ
        • Novo Nordisk Investigational Site
      • Sheffield, United Kingdom, S5 7AU
        • Novo Nordisk Investigational Site
      • Stevenage, United Kingdom, SG1 4AB
        • Novo Nordisk Investigational Site
      • Swansea, United Kingdom, SA2 8PP
        • Novo Nordisk Investigational Site
  • United States
    • California
      • La Jolla, California, United States, 92037
        • Novo Nordisk Investigational Site
      • Northridge, California, United States, 91325
        • Novo Nordisk Investigational Site
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Novo Nordisk Investigational Site
    • Florida
      • Miami, Florida, United States, 33136
        • Novo Nordisk Investigational Site
      • Orlando, Florida, United States, 32804
        • Novo Nordisk Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30318
        • Novo Nordisk Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Novo Nordisk Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Novo Nordisk Investigational Site
    • New Jersey
      • Teaneck, New Jersey, United States, 07666
        • Novo Nordisk Investigational Site
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27517
        • Novo Nordisk Investigational Site
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Novo Nordisk Investigational Site
    • Texas
      • Houston, Texas, United States, 77079
        • Novo Nordisk Investigational Site
      • Mesquite, Texas, United States, 75149
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
  • T1DM (type 1 diabetes mellitus) (as diagnosed clinically) for not more than 20 weeks prior to screening - Male or female, aged 18-45 (both inclusive) at the time of signing the informed consent form
  • Non-fasting peak C-peptide higher or equal to 0.2 nmol/l at visit 2
  • BMI (body mass index) higher or equal to 18.5 kg/m^2
  • Presence of one or more islet specific auto antibodies (glutamic acid decarboxylase (GAD), islet antigen-2 (IA2) or zinc-transporter 8 (ZnT8)) at screening
  • Insulin dependence unless in temporary spontaneous remission (honeymoon period)

Exclusion Criteria:

  • Daily insulin usage above 1 U/kg per day at screening or use of continuous subcutaneous insulin infusion (CSII)
  • History of recurrent (e.g. several times a year) of severe (e.g. pneumonia) or chronic infections or conditions predisposing to chronic infections (e.g., bronchiectasis and chronic osteomyelitis)
  • History of severe systemic fungal infection within the past 12 months prior to screening unless treated and resolved with appropriate documented therapy
  • Vaccination within 4 weeks before randomisation, Visit 3 (V3)
  • Receipt of any other concomitant medications or herbal products that can influence the immune system within 90 days prior to screening (V1)
  • History of pancreatitis (acute or chronic)
  • Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN2) or Medullary Thyroid Carcinoma (MTC)
  • Any past or current diagnosis of malignant neoplasms
  • Known impairment of the immune system, except for T1DM, coeliac disease, alopecia, autoimmune antibodies not considered clinical important (e.g. thyroid antibodies without any clinically important thyroid disease), and vitiligo

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
PLACEBO_COMPARATOR: Placebo
Drug: placebo
Placebo administered s.c (subcutaneously) or i.v ( intravenously). Subjects will continue their pre-trial insulin treatment
EXPERIMENTAL: NNC0114-0006 + Liraglutide
Drug: NNC0114-0006
NNC0114-0006 12 mg/kg administered i.v (intravenously) every 6 weeks. Subjects will continue their pre-trial insulin treatment
Drug: liraglutide
Liraglutide 1.8 mg administered s.c. (subcutaneously) daily. Subjects will continue their pre-trial insulin treatment
EXPERIMENTAL: NNC0114-0006 + Placebo
Drug: NNC0114-0006
NNC0114-0006 12 mg/kg administered i.v (intravenously) every 6 weeks. Subjects will continue their pre-trial insulin treatment
Drug: placebo
Placebo administered s.c (subcutaneously) or i.v ( intravenously). Subjects will continue their pre-trial insulin treatment
ACTIVE_COMPARATOR: Liraglutide + Placebo
Drug: liraglutide
Liraglutide 1.8 mg administered s.c. (subcutaneously) daily. Subjects will continue their pre-trial insulin treatment
Drug: placebo
Placebo administered s.c (subcutaneously) or i.v ( intravenously). Subjects will continue their pre-trial insulin treatment

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Area Under the Concentration-time Curve (AUC) 0-4h of Mixed Meal Tolerance Test (MMTT) Stimulated C-peptide at Week 54 Relative to Baseline
Time Frame: 0 - 4 hours post-dose on week 0 and week 54
Area under the concentration-time curve, from 0 to 4 hours (AUC0-4h) of a mixed meal tolerance test (MMTT) stimulated C-peptide at week 54 is presented as ratio to baseline. AUC of C-peptide was measured as Nano moles*hour per liter (nmol*h/L).
0 - 4 hours post-dose on week 0 and week 54

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
AUC0-2h of C-peptide at Week 54 Relative to Baseline
Time Frame: 0-2 hours post-dose on week 0 and week 54
Area under the concentration-time curve, from 0 to 2 hours (AUC0-2h) of a MMTT stimulated C-peptide at week 54 is presented as ratio to baseline. AUC of C-peptide was measured as 'nmol*h/L'.
0-2 hours post-dose on week 0 and week 54
Cmax of C-peptide at Week 54 Relative to Baseline
Time Frame: 0-4 hours post-dose on week 0 and week 54
Maximum observed concentration (Cmax) of a MMTT stimulated C-peptide at week 54 is presented as ratio to baseline. Cmax of C-peptide was measured as nanomoles per liter (nmol/L).
0-4 hours post-dose on week 0 and week 54
AUC0-4h of Glucose at Week 54 Relative to Baseline
Time Frame: 0 - 4 hours post-dose on week 0 and week 54
Area under the concentration-time curve, from 0 to 4 hours (AUC0-4h) of a MMTT stimulated glucose at week 54 is presented as ratio to baseline. AUC of glucose was measured as Milli moles*hour per liter (mmol*h/L).
0 - 4 hours post-dose on week 0 and week 54
AUC0-2h of Glucose at Week 54 Relative to Baseline
Time Frame: 0-2 hours post-dose on week 0 and week 54
Area under the concentration-time curve, from 0 to 2 hours (AUC0-2h) of a MMTT stimulated glucose at week 54 is presented as ratio to baseline. AUC of glucose is measured as 'mmol*h/L'.
0-2 hours post-dose on week 0 and week 54
Cmax of Glucose at Week 54 Relative to Baseline
Time Frame: 0-4 hours post-dose on week 0 and week 54
Maximum observed concentration (Cmax) of a MMTT stimulated glucose at week 54 is presented as ratio to baseline. Cmax of C-peptide was measured as 'mmol/L'.
0-4 hours post-dose on week 0 and week 54
Number of Treatment Emergent Adverse Events
Time Frame: Week 0-54; Week 54-80

An adverse event was any untoward medical occurrence in a participants administered a product, and which did not necessarily have a causal relationship with this treatment. An adverse event was defined as treatment emergent if the onset of the adverse event occurs on or after the first day of trial product administration. Number of treatment emergent adverse events from first dose of trial product to week 54 and week 80 are presented. Results are based on the on-treatment and on-observation period.

On-treatment period: From the day of first trial product administration to the day of the visit at week 54. On-observation: From the day after the visit at week 54 to the day of the last visit.
Week 0-54; Week 54-80
Number of Treatment Emergent Hyperglycaemic Episodes
Time Frame: Week 0-54; Week 54-80

Hyperglycaemic episodes were defined as treatment-emergent if the onset occurred on or after the first day of trial product administration. Number of treatment emergent episodes of hyperglycaemic episodes from first dose of trial product to week 54 and from week 54 to week 80 are presented. Results are based on the on-treatment and on-observation period.

On-treatment period: From the day of first trial product administration to the day of the visit at week 54. On-observation: From the day after the visit at week 54 to the day of the last visit.
Week 0-54; Week 54-80
Number of Treatment Emergent Episodes of Diabetic Ketoacidosis
Time Frame: Weeks 0-54; Weeks 54-80

Diabetic ketoacidosis episodes were defined as treatment-emergent if the onset occurred on or after the first day of trial product administration. Number of treatment emergent episodes of hyperglycaemic episodes from first dose of trial product to week 54 and from week 54 to week 80 are presented. Results are based on the on-treatment and on-observation period.

On-treatment period: From the day of first trial product administration to the day of the visit at week 54. On-observation: From the day after the visit at week 54 to the day of the last visit.
Weeks 0-54; Weeks 54-80
Number of Participants Experiencing Treatment Emergent Injection/Infusion Site Reactions Caused by NNC0114-0006/Liraglutide/Placebo Injection/Infusion
Time Frame: Week 0-54
Injection/infusion site reactions episodes were defined as treatment-emergent if the onset occurred on or after the first day of trial product administration. Number of participants experiencing treatment emergent episodes of injection/infusion site reactions episodes from first dose of trial product to week 54 (treatment period) is presented.
Week 0-54
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA)
Time Frame: Weeks 0-54; Weeks 54-80

Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 1 day after the date of last contact. Number of treatment-emergent hypoglycaemic episodes according to American Diabetes Association (ADA) classification from first dose of trial product to week 54 and from week 54 to week 80 are presented.

Results presented hypoglycaemia episodes were recorded as per ADA definition: Severe hypoglycaemia, Documented symptomatic hypoglycaemia, Asymptomatic hypoglycaemia, Probable symptomatic hypoglycaemia and Pseudo-hypoglycaemia.
Weeks 0-54; Weeks 54-80
Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk Definitions
Time Frame: Weeks 0-54; Weeks 54-80
Hypoglycaemia episodes were recorded as per Novo Nordisk definition: Symptomatic BG-confirmed: An episode that is blood glucose (BG) confirmed by plasma glucose (PG) value <3.1 mmol/L with symptoms consistent with hypoglycaemia. Asymptomatic BG-confirmed: An episode that is BG-confirmed by PG value <3.1 mmol/L without symptoms consistent with hypoglycaemia. Severe or BG-confirmed symptomatic: An episode that is severe according to the ISPAD classification or BG-confirmed by a PG value <3.1 mmol/L with symptoms consistent with hypoglycaemia. BG-confirmed: An episode that is BG-confirmed by a PG value <3.1 mmol/L with or without symptoms consistent with hypoglycaemia. Severe or BG-confirmed: An episode that is severe according to the International Society for Pediatric and Adolescent Diabetes (ISPAD) classification or BG-confirmed by a PG value <3.1 mmol/L with or without symptoms consistent with hypoglycaemia.
Weeks 0-54; Weeks 54-80
Change in Body Weight (kg)
Time Frame: (Week 0, week 54) and (week 0, week 80)
Change in body weight is measured at week 54 and week 80 respective to baseline. Body weight was measured in unit 'Kg'.
(Week 0, week 54) and (week 0, week 80)
Diabetes Retinopathy
Time Frame: Baseline, week 54 and week 80
Number of participants evaluated for diabetic retinopathy at baseline (Day -28 to -14), week 54 and week 80 are presented as 'yes', 'no' or 'unknown'.
Baseline, week 54 and week 80
Estimated Glomerular Filtration Rate (eGFR)- Ratio to Baseline
Time Frame: (Week 0, week 54) and (week 0, week 80)
The eGFR was measured using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula. Change in eGFR (measured in milliliters per minute per 1.73 square meters) from baseline (week 0) at week 54 and week 80 is presented as ratio to baseline.
(Week 0, week 54) and (week 0, week 80)
Change in Haematology: Erythrocytes
Time Frame: (Week 0, week 54) and (week 0, week 80)
Change in erythrocytes (measured in 10^12 cells per liter) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
(Week 0, week 54) and (week 0, week 80)
Change in Haematology: Haematocrit
Time Frame: (Week 0, week 54) and (week 0, week 80)
Change in haematocrit (measured in percentage '%') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
(Week 0, week 54) and (week 0, week 80)
Change in Haematology: Haemoglobin
Time Frame: (Week 0, week 54) and (week 0, week 80)
Change in haemoglobin (measured in millimoles per liter 'mmol/L') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
(Week 0, week 54) and (week 0, week 80)
Change in Haematology: Leukocytes
Time Frame: (Week 0, week 54) and (week 0, week 80)
Change in leukocytes (measured in 10^9 cells/L) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
(Week 0, week 54) and (week 0, week 80)
Change in Haematology: Mean Corpuscular Hemoglobin
Time Frame: (Week 0, week 54) and (week 0, week 80)
Change in mean Corpuscular hemoglobin (measured in femtomole 'fmol') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
(Week 0, week 54) and (week 0, week 80)
Change in Haematology: Mean Corpuscular Hemoglobin Concentration
Time Frame: (Week 0, week 54) and (week 0, week 80)
Change in mean corpuscular hemoglobin concentration (MCHC) (measured in gram per liter 'g/L') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
(Week 0, week 54) and (week 0, week 80)
Change in Haematology: Mean Corpuscular Volume
Time Frame: (Week 0, week 54) and (week 0, week 80)
Change in Mean Corpuscular volume (measured in femtoliter 'fL') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
(Week 0, week 54) and (week 0, week 80)
Change in Haematology: Thrombocytes
Time Frame: (Week 0, week 54) and (week 0, week 80)
Change in thrombocytes (measured in 10^9 cells per liter) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
(Week 0, week 54) and (week 0, week 80)
Change in Haematology: Eosinophil
Time Frame: (Week 0, week 54) and (week 0, week 80)
Change in eosinophil (measured in percentage '%') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
(Week 0, week 54) and (week 0, week 80)
Change in Haematology: Neutrophils
Time Frame: (Week 0, week 54) and (week 0, week 80)
Change in neutrophils (measured in percentage '%') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
(Week 0, week 54) and (week 0, week 80)
Change in Haematology: Basophils
Time Frame: (Week 0, week 54) and (week 0, week 80)
Change in basophils (measured in percentage '%') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
(Week 0, week 54) and (week 0, week 80)
Change in Haematology: Lymphocytes
Time Frame: (Week 0, week 54) and (week 0, week 80)
Change in lymphocytes (measured in percentage '%') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
(Week 0, week 54) and (week 0, week 80)
Change in Haematology: Monocytes
Time Frame: (Week 0, week 54) and (week 0, week 80)
Change in monocytes (measured in percentage '%') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
(Week 0, week 54) and (week 0, week 80)
Change in Biochemistry: Alanine Aminotransferase (ALAT)
Time Frame: (Week 0, week 54) and (week 0, week 80)
Change in ALAT (measured in units per liter [U/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
(Week 0, week 54) and (week 0, week 80)
Change in Biochemistry: Albumin
Time Frame: (Week 0, week 54) and (week 0, week 80)
Change in albumin (measured in gram per deciliter [g/dL]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
(Week 0, week 54) and (week 0, week 80)
Change in Biochemistry: Amylase
Time Frame: (Week 0, week 54) and (week 0, week 80)
Change in amylase (measured in units per liter [U/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
(Week 0, week 54) and (week 0, week 80)
Change in Biochemistry: Alkaline Phosphatase (ALP)
Time Frame: (Week 0, week 54) and (week 0, week 80)
Change in ALP (measured in units per liter [U/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
(Week 0, week 54) and (week 0, week 80)
Change in Biochemistry: Aspartate Aminotransferase (ASAT)
Time Frame: (Week 0, week 54) and (week 0, week 80)
Change in ASAT (measured in units per liter [U/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
(Week 0, week 54) and (week 0, week 80)
Change in Biochemistry: Total Bilirubin
Time Frame: (Week 0, week 54) and (week 0, week 80)
Change in Total bilirubin (measured in micromole per liter [umol/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
(Week 0, week 54) and (week 0, week 80)
Change in Biochemistry: Calcium Corrected
Time Frame: (Week 0, week 54) and (week 0, week 80)
Change in calcium corrected (measured in millimole per liter [mmol/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
(Week 0, week 54) and (week 0, week 80)
Change in Biochemistry: Chloride
Time Frame: (Week 0, week 54) and (week 0, week 80)
Change in chloride (measured in millimole per liter [mmol/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
(Week 0, week 54) and (week 0, week 80)
Change in Biochemistry: Creatine Kinase
Time Frame: (Week 0, week 54) and (week 0, week 80)
Change in creatine kinase (measured in units per liter [U/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
(Week 0, week 54) and (week 0, week 80)
Change in Biochemistry: Creatinine
Time Frame: (Week 0, week 54) and (week 0, week 80)
Change in creatinine (measured in micromole per liter [umol/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
(Week 0, week 54) and (week 0, week 80)
Change in Biochemistry: Gamma-glutamyl Transferase (GGT)
Time Frame: (Week 0, week 54) and (week 0, week 80)
Change in GGT (measured in units per liter [U/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
(Week 0, week 54) and (week 0, week 80)
Change in Biochemistry: C-reactive Protein Serum
Time Frame: (Week 0, week 54) and (week 0, week 80)
Change in C-reactive protein serum (measured in milligrams per liter [mg/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
(Week 0, week 54) and (week 0, week 80)
Change in Biochemistry: Lactate Dehydrogenase
Time Frame: (Week 0, week 54) and (week 0, week 80)
Change in Lactate Dehydrogenase (measured in units per liter [U/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
(Week 0, week 54) and (week 0, week 80)
Change in Biochemistry: Lipase
Time Frame: (Week 0, week 54) and (week 0, week 80)
Change in lipase (measured in units per liter [U/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
(Week 0, week 54) and (week 0, week 80)
Change in Biochemistry: Magnesium
Time Frame: (Week 0, week 54) and (week 0, week 80)
Change in magnesium (measured in millimole per liter [mmol/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
(Week 0, week 54) and (week 0, week 80)
Change in Biochemistry: Phosphate
Time Frame: (Week 0, week 54) and (week 0, week 80)
Change in phosphate (measured in millimole per liter [mmol/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
(Week 0, week 54) and (week 0, week 80)
Change in Biochemistry: Potassium
Time Frame: (Week 0, week 54) and (week 0, week 80)
Change in potassium (measured in millimole per liter [mmol/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
(Week 0, week 54) and (week 0, week 80)
Change in Biochemistry: Sodium
Time Frame: (Week 0, week 54) and (week 0, week 80)
Change in sodium (measured in millimole per liter [mmol/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
(Week 0, week 54) and (week 0, week 80)
Change in Biochemistry: Total Protein
Time Frame: (Week 0, week 54) and (week 0, week 80)
Change in total protein (measured in gram per liter [g/dL]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
(Week 0, week 54) and (week 0, week 80)
Change in Biochemistry: Blood Urea Nitrogen Serum
Time Frame: (Week 0, week 54) and (week 0, week 80)
Change in blood urea nitrogen serum (measured in milligram per deciliter [mg/dL]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
(Week 0, week 54) and (week 0, week 80)
Change in Biochemistry: Uric Acid
Time Frame: (Week 0, week 54) and (week 0, week 80)
Change in Uric Acid (measured in milligram per deciliter [mg/dL]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
(Week 0, week 54) and (week 0, week 80)
Change in International Normalised Ratio (INR)
Time Frame: (Week 0, week 54) and (week 0, week 80)
Change in INR (measured in ratio]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
(Week 0, week 54) and (week 0, week 80)
Change in D-Dimer
Time Frame: (Week 0, week 54) and (week 0, week 80)
Change in D-Dimer (measured in mg/L) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
(Week 0, week 54) and (week 0, week 80)
Change in Lipids: Total Cholesterol (Ratio to Baseline)
Time Frame: (Week 0, week 54) and (week 0, week 80)
Change in total cholesterol (measured in mmol/L) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
(Week 0, week 54) and (week 0, week 80)
Change in Lipids: Free Fatty Acids (Ratio to Baseline)
Time Frame: (Week 0, week 54) and (week 0, week 80)
Change in total free fatty acids (measured in mmol/L) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
(Week 0, week 54) and (week 0, week 80)
Change in Lipids: HDL Cholesterol (Ratio to Baseline)
Time Frame: (Week 0, week 54) and (week 0, week 80)
Change in HDL cholesterol (measured in mmol/L) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
(Week 0, week 54) and (week 0, week 80)
Change in Lipids: LDL Cholesterol (Ratio to Baseline)
Time Frame: (Week 0, week 54) and (week 0, week 80)
Change in LDL cholesterol (measured in mmol/L) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
(Week 0, week 54) and (week 0, week 80)
Change in Lipids: Triglycerides (TG) (Ratio to Baseline)
Time Frame: (Week 0, week 54) and (week 0, week 80)
Change in Triglycerides (measured in mmol/L) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
(Week 0, week 54) and (week 0, week 80)
Change in Total Immunoglobulin E (IgE)
Time Frame: (Week 0, week 54) and (week 0, week 80)
Change in IgE (measured in kilo international units per liter [kIU/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
(Week 0, week 54) and (week 0, week 80)
Change in Urinalysis: Urine Dipsticks
Time Frame: Week 0, week 54 and week 80
Urinalysis was performed by urine dipsticks for protein, glucose, erythrocytes, ketones leukocytes, nitrite, pH and specific gravity and categorised as normal, abnormal not clinically significant (NCS) and abnormal clinially significant (CS). Number of participants in each category at baseline (week 0), week 54 and 80 are presented.
Week 0, week 54 and week 80
Change in Cytokines: Interleukin (IL)-6
Time Frame: Week 0, week 54 and week 80
IL-6 levels at baseline (week 0), weeks 54 and 80 are evaluated and presented.
Week 0, week 54 and week 80
Change in Cytokines- Interleukin (IL)-10
Time Frame: Week 0, week 54 and week 80
IL-10 levels at baseline (week 0), weeks 54 and 80 are evaluated and presented.
Week 0, week 54 and week 80
Change in Cytokines: Interleukin (IL)-17
Time Frame: Week 0, week 54 and week 80
IL-17 levels at baseline (week 0), weeks 54 and 80 are evaluated and presented.
Week 0, week 54 and week 80
Change in Cytokines: Interferon (IFN) Gamma
Time Frame: Week 0, week 54 and week 80
IFN gamma levels at baseline (week 0), weeks 54 and 80 are evaluated and presented.
Week 0, week 54 and week 80
Change in Cytokines: TNF-alpha
Time Frame: Week 0, week 54 and week 80
TNF-alpha levels at baseline (week 0), weeks 54 and 80 are evaluated and presented.
Week 0, week 54 and week 80
Change in Hormone Level: Thyroid Stimulating Hormone (TSH)
Time Frame: (Week 0, week 54) and (week 0, week 80)
Change in TSH (measured in milli international units per liter [mIU/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
(Week 0, week 54) and (week 0, week 80)
Change in Hormone Level: Calcitonin
Time Frame: (Week 0, week 54) and (week 0, week 80)
Change in Calcitonin (measured in nanogram per liter [ng/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
(Week 0, week 54) and (week 0, week 80)
Change in Systolic and Diastolic Blood Pressure
Time Frame: (Week 0, week 54) and (week 0, week 80)
Change in systolic blood pressure (SBP) and diastolic blood pressure (DBP) are evaluated from baseline (week 0) to weeks 54 and 80.
(Week 0, week 54) and (week 0, week 80)
Change in Pulse
Time Frame: (Week 0, week 54) and (week 0, week 80)
Change in pulse is evaluated from baseline (week 0) to weeks 54 and 80
(Week 0, week 54) and (week 0, week 80)
Change in Body Temperature
Time Frame: Week 0, week 54) and (week 0, week 80)
Change in body temperature is evaluated from baseline (week 0) to weeks 54 and 80.
Week 0, week 54) and (week 0, week 80)
Change in Respiratory Rate
Time Frame: (Week 0, week 54) and (week 0, week 80)
Change in respiratory rate is evaluated from baseline (week 0) to weeks 54 and 80.
(Week 0, week 54) and (week 0, week 80)
Change in Electrocardiogram (ECG)
Time Frame: Week 0, week 54 and week 80
The ECG was assessed by the investigator at baseline (week 0), week 54 and week 80 and categorised as normal, abnormal NCS or abnormal CS. Number of participants in each ECG category at baseline, week 54 and week 80 are presented.
Week 0, week 54 and week 80
Change in Eye-examination
Time Frame: Week 0, week 54 and week 80
Dilated fundoscopy or fundus photography was performed by the investigator at week 0, week 54 and week 80. The results of the examination were interpreted for each eye (left/right) are categorised as normal, abnormal NCS or abnormal CS. Number of participants in each category at week 0, week 54 and week 80 are presented.
Week 0, week 54 and week 80
Change in Physical Examination
Time Frame: Week 0, week 54 and week 80
Physical examination parameters are categorised as general appearance; head, ears, eyes, nose, throat, neck; respiratory system;cardiovascular system; gastrointestinal system including mouth; musculoskeletal system; central and peripheral nervous system; skin; lymph node palpation and thyroid gland. Investigator assessed the participants with normal, abnormal not clinically significant (NCS) and abnormal clinically significant (CS) findings at week 0, week 54 and week 80 are presented.
Week 0, week 54 and week 80
Occurrence of Anti-NNC0114-0006 Antibodies
Time Frame: Week 0, week 54 and week 80
This outcome measure was applicable for NNC0114-0006 + Liraglutide treatment arm and NNC0114-0006 treatment arm. Participants was assessed for anti-NNC0114-0006 antibodies. Participant who reported anti-NNC0114-0006 antibodies were further analyzed for cross-reactivity. Number of participants who measured with anti-NNC0114-0006 antibodies at week 54 and week 80 are presented.
Week 0, week 54 and week 80
Occurrence of Anti-liraglutide Antibodies
Time Frame: Week 0, week 54 and week 80
This outcome measure is applicable for NNC0114-0006 + Liraglutide treatment arm and Liraglutide treatment arm. Participants was assessed for anti-liraglutide antibodies. Participant who reported anti-liraglutide antibodies were further analyzed for cross-reactivity. Number of participants who measured with anti-liraglutide antibodies at week 54 and week 80 are presented.
Week 0, week 54 and week 80
Change in Insulin Dose
Time Frame: (Week 0, week 54) and (week 0, week 80)
The total daily insulin dose was derived as the average of the doses reported on the three days prior to the visit. Change in daily total insulin dose from baseline (week 0) after 54 weeks of treatment and week 80 are presented.
(Week 0, week 54) and (week 0, week 80)
Change in Number of Insulin Injections
Time Frame: (Week 0, week 54) and (week 0, week 80)
The number of insulin injections was derived as the average of the reported number on the three days prior to the visit. The change in number of insulin injections per day (count) from baseline (week 0) after 54 weeks of treatment and week 80 are presented.
(Week 0, week 54) and (week 0, week 80)
Number of Weeks Off Bolus Insulin
Time Frame: (Week 0 to week 54) and (week 0 to week 80)
The number of weeks off bolus insulin after 54 weeks of treatment and week 80 are presented.
(Week 0 to week 54) and (week 0 to week 80)
Change in HbA1c
Time Frame: (Week 0, week 54) and (week 0, week 80)
Change in glycosylated haemoglobin (HbA1c) is evaluated from baseline (week 0) to weeks 54 and 80.
(Week 0, week 54) and (week 0, week 80)
Change in Fasting Plasma Glucose
Time Frame: (Week 0, week 54) and (week 0, week 80)
Change in fasting plasma glucose is evaluated from baseline (week 0) to weeks 54 and 80.
(Week 0, week 54) and (week 0, week 80)
Change in Fasting C-peptide- Ratio to Baseline
Time Frame: (Week 0, week 54) and (week 0, week 80)
Change in fasting C-peptide (measured in nanomole per liter [nmol/L]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
(Week 0, week 54) and (week 0, week 80)
Change in Fasting Glucagon- Ratio to Baseline
Time Frame: (Week 0, week 54) and (week 0, week 80)
Change in fasting glucagon (measured in picogram per milliliter [pg/mL]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.
(Week 0, week 54) and (week 0, week 80)
7-point SMPG Profiles
Time Frame: Week 54 and Week 80
Participants measured plasma glucose values using the blood glucose meter at 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime. 7-point SMPG profile values are presented for week 54 and week 80.
Week 54 and Week 80
Change in 7- Points Self-measured Plasma Glucose (SMPG) Postprandial Glucose /Prandial Increment: Breakfast, Lunch, Dinner
Time Frame: (Week 0, week 54) and (week 0, week 80)
Participants measured plasma glucose values using the blood glucose meter at 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner and at bedtime. Change from baseline (week 0) to week 54 and week 80 in 7-point SMPG postprandial glucose /prandial increment (breakfast, lunch and dinner) value are presented.
(Week 0, week 54) and (week 0, week 80)
Change in 7- Points Self-measured Plasma Glucose (SMPG) Postprandial Glucose /Prandial Increment (Average Over the Three Meals)
Time Frame: (Week 0, week 54) and (week 0, week 80)
Participants measured plasma glucose values using the blood glucose meter at 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime. Change from baseline (week 0) to week 54 and week 80 in 7-point self-measured plasma glucose (SMPG) postprandial glucose /prandial increment (average over the three meals) value is presented.
(Week 0, week 54) and (week 0, week 80)
Change in Mean of 7-point Profiles
Time Frame: (Week 0, week 54) and (week 0, week 80)
Participants measured plasma glucose values using the blood glucose meter at 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime. Change from baseline (week 0) to week 54 and week 80 in mean of 7-point profiles value is presented.
(Week 0, week 54) and (week 0, week 80)
Before Breakfast 7- Points Self Measured Plasma Glucose (SMPG)
Time Frame: Week 54 and week 80
Participants measured plasma glucose values using the blood glucose meter at 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner and at bedtime. Before breakfast 7-point self-measured plasma glucose (SMPG) profile values are presented at week 54 and week 80.
Week 54 and week 80
Area Under the NNC0114-0006 Concentration-time Curve Over a Dosing Interval at Steady State (AUCtau, NNC0114-0006)
Time Frame: Pre-dose and 1 hour post-dose during week 48 to week 54
AUCtau, NNC0114-0006 was derived as the area under the concentration-time curve using the linear trapezoidal technique based on observed values and actual measurement times between 0 and 6 weeks (after the last dose). This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms.
Pre-dose and 1 hour post-dose during week 48 to week 54
Terminal Half-life (t½) After Last Dose of NNC0114-0006
Time Frame: Pre-dose and 1 hour post-dose during week 48 to week 80
Terminal half life was calculated as log(2)/λz. The terminal rate constant λz was determined through linear regression with the logarithm to concentration as the response variable and actual measurement time as the explanatory variable. Valid observations from the terminal part of the curve, which is approximately linear, were used for the determination. This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms.
Pre-dose and 1 hour post-dose during week 48 to week 80
Apparent Volume of Distribution of NNC0114-0006 at Steadystate (Vss, NNC0114-0006)
Time Frame: Pre-dose and 1 hour post-dose during week 48 to week 80
The apparent volume of distribution of NNC0114-0006 at steady-state was calculated as mean residence time of (MRT) of NNC0114-0006 multiplied by clearance of NNC0114-0006 at steady state. This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms.
Pre-dose and 1 hour post-dose during week 48 to week 80
Clearance of NNC0114-0006 at Steady State (CLss, NNC0114-0006)
Time Frame: Pre-dose and 1 hour post-dose during week 48 to week 54
Clearance of NNC0114-0006 at steady state was calculated as dose/AUCtau, NNC0114-0006. This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms.
Pre-dose and 1 hour post-dose during week 48 to week 54
Mean Residence Time of NNC0114-0006 (MRT, NNC0114-0006)
Time Frame: Pre-dose and 1 hour post-dose during week 48 to week 80
This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms. Mean residence time of NNC0114-0006 is presented.
Pre-dose and 1 hour post-dose during week 48 to week 80
Accumulation Ratio of NNC114-0006 (RA,AUC, NNC0114-0006)
Time Frame: Pre-dose and 1 hour post-dose during (week 0 to week 6) and (week 48 to week 54)
Accumulation ratio of NNC114-0006 was defined as AUC48-54 weeks/AUC0-6 weeks. This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms.
Pre-dose and 1 hour post-dose during (week 0 to week 6) and (week 48 to week 54)
Observed NNC0114-0006 Concentration Prior to Dosing of NNC0114-0006 at Steady State (Ctrough, NNC0114-0006)
Time Frame: Week 48 (predose)
Ctrough of NNC0114-0006 was defined as concentration prior to dosing of NNC0114-0006 at steady state. This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms.
Week 48 (predose)
Observed NNC0114-0006 Concentration 1 Hour After Dosing of NNC0114-0006 at Steady State (C1h, NNC0114-0006)
Time Frame: Week 48 (1 hour post-dose)
C1h, NNC0114-0006 was defined as concentration of NNC0114-0006 at 1 hour after dosing of NNC0114-0006 at steady state. This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms.
Week 48 (1 hour post-dose)
Liraglutide Concentration at Steady State (C Liraglutide)
Time Frame: Week 54 (post-dose)
C liraglutide was defined as the liraglutide concentration at steady state. This outcome measure was applicable for NNC0114-0006 + Liraglutide and Liraglutide treatment arms.
Week 54 (post-dose)
Change in Biomarker: Immune Phenotyping- B Cell Panel
Time Frame: Week 0, week 54 and week 80

B cell panel is evaluated by Immune phenotyping of peripheral blood mononuclear cells (PBMC) at baseline (week 0), week 54 and week 80.

In below table CD refer to Cluster of Differentiation; IgMNeg refers to Immunoglobulin M negative; IgDNeg refers to Immunoglobulin D negative.
Week 0, week 54 and week 80
Change in Biomarker: Immune Phenotyping- Natural Killer (NK) Cell Panel
Time Frame: Week 0, week 54 and week 80

NK cell panel is evaluated by Immune phenotyping of peripheral blood mononuclear cells (PBMC) at baseline (week 0), week 54 and week 80.

In below table ADCC refer to Antibody-dependent cellular cytotoxicity; CD refer to Cluster of Differentiation.
Week 0, week 54 and week 80
Change in Biomarker: Immune Phenotyping- T Cell Panel
Time Frame: Week 0, week 54 and week 80

T cell panel is evaluated by Immune phenotyping of peripheral blood mononuclear cells (PBMC) at baseline (week 0), week 54 and week 80.

In below table CD refer to Cluster of Differentiation; TEMRA refers to terminally differentiated effector memory cells re-expressing CD45RA; CCR refers to C-C chemokine receptor; TREG refers to Regulatory T cells.
Week 0, week 54 and week 80
Change in Biomarker: Immune Phenotyping- T Follicular Helper (TfH) Cell Panel
Time Frame: Week 0, week 54 and week 80

TfH cell panel is evaluated by Immune phenotyping of peripheral blood mononuclear cells (PBMC) at baseline (week 0), week 54 and week 80.

In below table CTFH refer to Circulating T follicular helper; ICOS refers to inducible T-cell co-stimulator; PD refers to Programmed cell death protein; CCR refers to C-C chemokine receptor; CXCR refers to C-X-C chemokine receptor; CD refer to Cluster of Differentiation; CM refers to central memory; EM refers to effector memory, TIGIT refers to T cell immunoreceptor with Ig and ITIM domains.
Week 0, week 54 and week 80
Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel
Time Frame: Week 0, week 54 and week 80

Myeloid panel is evaluated by Immune phenotyping of peripheral blood mononuclear cells (PBMC) at baseline (week 0), week 54 and week 80.

In below table HLA refers to Human Leukocyte Antigen; MDSC refers to myeloid-derived suppressor cell; DC refers to Dendritic cells; MYDC refers to Myeloid Dendritic Cells; IMMYE_MDSC refers to Immature myeloid cells & a subset of myeloid suppressor cells within the CD14-HLA class II- myeloid cell population.
Week 0, week 54 and week 80
Autoantibodies Against Glutamic Acid Decarboxylase (GAD)
Time Frame: Week 0, week 54 and week 80
Participants were analyzed for autoantibodies against Glutamic acid decarboxylase (GAD) and were categorized as negative and positive.
Week 0, week 54 and week 80
Autoantibodies Against Zinc-transporter 8 (ZnT8)
Time Frame: Week 0, week 54 and week 80
Participants were analyzed for autoantibodies against Zinc-transporter 8 (ZnT8) and were categorized as negative and positive.
Week 0, week 54 and week 80
Autoantibodies Against Islet Antigen-2 (IA2)
Time Frame: Week 0, week 54 and week 80
Participants were analyzed for autoantibodies against Islet antigen-2 (IA2) and were categorized as negative and positive.
Week 0, week 54 and week 80
Autoantibodies Against Insulin Autoantibodies (IAA)
Time Frame: Week 0, week 54 and week 80
Participants were analyzed for autoantibodies against Insulin autoantibodies (IAA) and were categorized as negative and positive.
Week 0, week 54 and week 80
Change in Biomarker: Total Interleukin-21 (IL-21)
Time Frame: Week 0, week 54 and week 80
IL-21 is evaluated at baseline (week 0), week 54 and week 80.
Week 0, week 54 and week 80
Change in Biomarker: Serum Vitamin D (1,25 Dehydroxy-calciferol)
Time Frame: Week 0, week 54 and week 80
Serum vitamin D is evaluated at baseline (week 0), week 54 and week 80.
Week 0, week 54 and week 80
Change in Short Form 36 Health Survey (SF-36)
Time Frame: (Week 0, week 54) and (week 0, week 80)
SF-36v2™ questionnaire measured the HRQoL on 8 domains (Bodily Pain, General Health, Mental Health, Physical Functioning, Role Emotion, Physical Health, Social Functioning and Vitality) on individual scale ranges. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. Change from baseline (week 0) to week 54 and week 80 in SF-36 score is presented.The MCS measure is derived from domain scales of vitality, social functioning, role emotional and mental health. The PCS measure is derived from domain scales of physical functioning, role-physical, bodily pain, and general health. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. A positive change score indicate an improvement since baseline.
(Week 0, week 54) and (week 0, week 80)
Change in Experience of Treatment Benefits and Barriers (ETBB)
Time Frame: (Week 0, week 54) and (week 0, week 80)
Treatment Benefits and Barriers (ETBB) questionnaire measured diabetes-specific health beliefs on 2 categories: Total Score for Perceived Barriers and Perceived Benefits. The measurement of perceived benefits of, and barriers to, treatment was achieved by creating a pool 28 statements each with a 7-point scale ranging from strongly agree (6) to strongly disagree (0). ETBB benefits score was calculated using the responses from questions 1, 4, 7, 8, 10, and 12 and ETBB barriers score was calculated using the responses from questions 2, 3, 5, 6, 9, and 11. Both was calculated as the sum of responses divided by number of responses received multiplied by the maximum number of responses. Based on the responses used the maximum responses available was 6. The higher score indicates more perceived benefits or more perceived barrier.
(Week 0, week 54) and (week 0, week 80)
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ)
Time Frame: (Week 0, week 54) and (week 0, week 80)
Change from baseline (week 0) in DTSQ is evaluated at week 54 and 80. The DTSQs items are scored on a 7-point graded response scale ranging from 6 to 0. Higher score indicates a higher level of glycaemia/treatment satisfaction.
(Week 0, week 54) and (week 0, week 80)
Area Under the Concentration-time Curve (AUC) 0-4h of Mixed Meal Tolerance Test (MMTT) Stimulated C-peptide at Week 80 Relative to Baseline
Time Frame: 0 - 4 hours post-dose on week 0 and week 80
Area under the concentration-time curve, from 0 to 4 hours (AUC0-4h) of a mixed meal tolerance test (MMTT) stimulated C-peptide at week 80 is presented as ratio to baseline. AUC of C-peptide was measured as Nano moles*hour per liter (nmol*h/L).
0 - 4 hours post-dose on week 0 and week 80
AUC0-2h of C-peptide at Week 80 Relative to Baseline
Time Frame: 0-2 hours post-dose on week 0 and week 80
Area under the concentration-time curve, from 0 to 2 hours (AUC0-2h) of a MMTT stimulated C-peptide at week 80 is presented as ratio to baseline. AUC of C-peptide was measured as 'nmol*h/L'.
0-2 hours post-dose on week 0 and week 80
Cmax of C-peptide at Week 80 Relative to Baseline
Time Frame: 0-4 hours post-dose on week 0 and week 80
Maximum observed concentration (Cmax) of a MMTT stimulated C-peptide at week 80 is presented as ratio to baseline. Cmax of C-peptide was measured as nanomoles per liter (nmol/L).
0-4 hours post-dose on week 0 and week 80
AUC0-4h of Glucose at Week 80 Relative to Baseline
Time Frame: 0 - 4 hours post-dose on week 0 and week 80
Area under the concentration-time curve, from 0 to 4 hours (AUC0-4h) of a MMTT stimulated glucose at week 80 is presented as ratio to baseline. AUC of glucose was measured as Milli moles*hour per liter (mmol*h/L).
0 - 4 hours post-dose on week 0 and week 80
AUC0-2h of Glucose at Week 80 Relative to Baseline
Time Frame: 0-2 hours post-dose on week 0 and week 80
Area under the concentration-time curve, from 0 to 2 hours (AUC0-2h) of a MMTT stimulated glucose at week 80 is presented as ratio to baseline. AUC of glucose was measured as 'mmol*h/L'.
0-2 hours post-dose on week 0 and week 80
Cmax of Glucose at Week 80 Relative to Baseline
Time Frame: 0-4 hours post-dose on week 0 and week 80
Maximum observed concentration (Cmax) of a MMTT stimulated glucose at week 80 is presented as ratio to baseline. Cmax of C-peptide was measured as 'mmol/L'.
0-4 hours post-dose on week 0 and week 80

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 10, 2015

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 27, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 11, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2015

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 13, 2015

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 9, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NN9828-4150
  • 2014-001215-39 (EUDRACT_NUMBER)
  • U1111-1154-7172 (OTHER: WHO)
  • REec-2015-1768 (REGISTRY: Spanish registry)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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