A Trial Comparing Insulin Degludec/Liraglutide, Insulin Degludec, and Liraglutide in Chinese Subjects With Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Drugs (OADs) (DUAL™ I China)

November 18, 2022 updated by: Novo Nordisk A/S

A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide, Insulin Degludec, and Liraglutide in Chinese Subjects With Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Drugs (OADs)

This trial is conducted in Asia. The aim of this trial is to confirm the efficacy of insulin degludec/liraglutide in controlling glycaemia in Chinese subjects with type 2 diabetes mellitus inadequately controlled on oral antidiabetic agents

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.
720

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 3

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

  • China
      • Fuzhou, China, 350005
        • Novo Nordisk Investigational Site
    • Anhui
      • Hefei, Anhui, China, 230061
        • Novo Nordisk Investigational Site
    • Beijing
      • Beijing, Beijing, China, 100071
        • Novo Nordisk Investigational Site
      • Beijing, Beijing, China, 101200
        • Novo Nordisk Investigational Site
    • Chongqing
      • ChongQing, Chongqing, China, 404000
        • Novo Nordisk Investigational Site
    • Fujian
      • Fuzhou, Fujian, China, 350025
        • Novo Nordisk Investigational Site
      • Fuzhou, Fujian, China, 350001
        • Novo Nordisk Investigational Site
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Novo Nordisk Investigational Site
      • Guangzhou, Guangdong, China, 510515
        • Novo Nordisk Investigational Site
      • Guangzhou, Guangdong, China, 510080
        • Novo Nordisk Investigational Site
    • Hebei
      • Cangzhou, Hebei, China, 061000
        • Novo Nordisk Investigational Site
      • Shijiazhuang, Hebei, China, 050000
        • Novo Nordisk Investigational Site
      • Shijiazhuang, Hebei, China, 050051
        • Novo Nordisk Investigational Site
    • Jiangsu
      • Changzhou, Jiangsu, China, 213003
        • Novo Nordisk Investigational Site
      • Huai'an, Jiangsu, China, 223002
        • Novo Nordisk Investigational Site
      • Huai'an, Jiangsu, China, 223300
        • Novo Nordisk Investigational Site
      • Nanjing, Jiangsu, China, 210011
        • Novo Nordisk Investigational Site
      • Nanjing, Jiangsu, China, 210012
        • Novo Nordisk Investigational Site
      • Nanjing, Jiangsu, China, 210029
        • Novo Nordisk Investigational Site
      • Zhenjiang, Jiangsu, China, 212001
        • Novo Nordisk Investigational Site
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Novo Nordisk Investigational Site
    • Jilin
      • Changchun, Jilin, China, 130021
        • Novo Nordisk Investigational Site
    • Liaoning
      • Dalian, Liaoning, China, 116011
        • Novo Nordisk Investigational Site
    • Ningxia
      • Yinchuan, Ningxia, China, 750004
        • Novo Nordisk Investigational Site
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • Novo Nordisk Investigational Site
    • Shandong
      • Jinan, Shandong, China, 250013
        • Novo Nordisk Investigational Site
    • Shanghai
      • Pudong New District, Shanghai, China, 201200
        • Novo Nordisk Investigational Site
      • Shanghai, Shanghai, China, 200240
        • Novo Nordisk Investigational Site
      • Shanghai, Shanghai, China, 200040
        • Novo Nordisk Investigational Site
      • Shanghai, Shanghai, China, 200072
        • Novo Nordisk Investigational Site
      • Shanghai, Shanghai, China, 200336
        • Novo Nordisk Investigational Site
      • Shanghai, Shanghai, China, 200080
        • Novo Nordisk Investigational Site
      • Shanghai, Shanghai, China, 200025
        • Novo Nordisk Investigational Site
      • Shanghai, Shanghai, China, 200123
        • Novo Nordisk Investigational Site
    • Tianjin
      • Tianjin, Tianjin, China, 300052
        • Novo Nordisk Investigational Site
    • Yunnan
      • Kunming, Yunnan, China, 650101
        • 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

14 years and older (Adult, Older 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
  • Type 2 diabetes mellitus (clinically diagnosed)
  • Male or female, age at least 18 years at the time of signing informed consent
  • HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis, with the aim of a median of8.3%. When approximately 50% of the randomised subjects have an HbA1c above 8.3%, the remaining subjects randomised must have an HbA1c below or equal to 8.3%; or when approximately 50% of the randomised subjects have an HbA1c below or equal to 8.3%, the remaining subjects randomised must have an HbA1c above 8.3%
  • Current treatment for at least 90 calendar days prior to screening with metformin plus/minus one other OAD: α-glucosidase inhibitors, sulphonylureas, glinides or thiazolidinediones. For above or equal to 60 calendar days prior to screening subjects should be on a stable dose of:
  • Metformin (above or equal to 1500 mg or max tolerated dose) or
  • Metformin (above or equal to 1500 mg or max tolerated dose) and sulphonylureas (above or equal to half of the max approved dose according to local label) or
  • Metformin (above or equal to 1500 mg or max tolerated dose) and glinides (above or equal to half of the max approved dose according to local label) or
  • Metformin (above or equal to 1500 mg or max tolerated dose) and α-glucosidase inhibitors (above or equal to half of the max approved dose according to local label) or
  • Metformin (above or equal to 1500 mg or max tolerated dose) and thiazolidinediones (above or equal to half of the max approved dose according to local label)

Exclusion Criteria:

  • Treatment with insulin (except for short-term treatment at the discretion of the investigator)
  • Treatment with glucagon-like-peptide-1 receptor agonists or dipeptidyl-peptidase-4 inhibitors within 90 days prior to screening
  • Impaired liver function, defined as alanine aminotransferase above or equal to 2.5 times upper normal range
  • Impaired renal function defined as serum-creatinine above or equal to 133 μmol/L for males and above or equal to 125 μmol/L for females, or as defined according to local contraindications for metformin
  • Screening calcitonin above or equal to 50 ng/L
  • Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)
  • Cardiac disorder defined as: congestive heart failure (NYHA class III-IV), diagnosis of unstable angina pectoris, cerebral stroke and/or myocardial infarction within the last 12 months prior to screening and/or planned coronary, carotid or peripheral artery revascularisation procedures
  • Severe uncontrolled treated or untreated hypertension (systolic blood pressure above or equal to 180 mmHg or diastolic blood pressure above or equal to 100 mmHg
  • Proliferative retinopathy or maculopathy (macular oedema), requiring acute treatment
  • History of pancreatitis (acute or chronic)

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 Assignment
  • Masking: None (Open Label)

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.
Active Comparator: Liraglutide
Drug: Liraglutide

Subcutaneously (s.c., under the skin)administration once daily in combination with metformin.

For 26 weeks.
Experimental: Insulin degludec/liraglutide
Drug: Insulin degludec/liraglutide

Subcutaneously (s.c., under the skin)administration once daily in combination with metformin.

For 26 weeks.
Active Comparator: Insulin degludec
Drug: Insulin degludec

Subcutaneously (s.c., under the skin)administration once daily in combination with metformin.

For 26 weeks.

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
Change in HbA1c
Time Frame: Week 0, week 26
Change in HbA1c from baseline (week 0) after 26 weeks of treatment is presented.
Week 0, week 26

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
Change in Body Weight
Time Frame: Week 0, week 26
Change in body weight from baseline (week 0) after 26 weeks of treatment is presented.
Week 0, week 26
Number of Treatment Emergent Severe or BG Confirmed Hypoglycaemic Episodes
Time Frame: Weeks 0-26
Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the American Diabetes Association (ADA) classification (requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or blood glucose (BG) confirmed by a plasma glucose (PG) value < 3.1 millimoles per liter (mmol/L) with or without symptoms consistent with hypoglycaemia. 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 7 calendar days after the last day on trial product. The number of episodes are represented as rates. The observed rates of treatment-emergent severe or BG confirmed hypoglycaemic episodes per patient years of exposure (PYE) (number of episodes divided by PYE multiplied by 100) during 26 weeks of treatment are presented.
Weeks 0-26
Insulin Dose
Time Frame: Week 26
The actual daily total insulin dose after 26 weeks of treatment is presented. This outcome measure is only applicable for Insulin degludec/liraglutide and Insulin degludec treatment arms.
Week 26
Participants Who Achieved HbA1c < 7.0%, American Diabetes Association (ADA) Target (Yes/no)
Time Frame: Week 26
Number of participants who achieved ADA HbA1c target (HbA1c < 7.0%) (yes/no) after 26 weeks of treatment are presented.
Week 26
Participants Who Achieved HbA1c ≤ 6.5%, International Diabetes Federation (IDF) Target (Yes/no)
Time Frame: Week 26
Number of participants who achieved IDF HbA1c target (HbA1c ≤ 6.5%) (yes/no) after 26 weeks of treatment are presented.
Week 26
Participants Who Achieved HbA1c <7.0% and Change in Body Weight From Baseline Below or Equal to Zero
Time Frame: Week 26
Number of participants who achieved ADA HbA1c target (HbA1c < 7.0%) (yes/no) and change from baseline in body weight below or equal to zero after 26 weeks are presented. Missing values are imputed by LOCF.
Week 26
Participants Who Achieved HbA1c ≤ 6.5% and Change From Baseline in Body Weight Below or Equal to Zero
Time Frame: Week 26
Number of participants who achieved IDF HbA1c target (HbA1c ≤ 6.5%) (yes/no) and change from baseline in body weight below or equal to zero after 26 weeks are presented. Missing values are imputed by LOCF.
Week 26
Participants Who Achieved HbA1c < 7.0% Without Severe or Blood Glucose (BG) Confirmed Hypoglycaemic Episodes
Time Frame: Week 26
Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a PG value <3.1 mmol/L with or without symptoms consistent with hypoglycaemia. 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 7 calendar days after the last day on trial product. Number of participants who achieved ADA HbA1c target (HbA1c <7.0%) (yes/no) after 26 weeks of treatment and without severe or BG confirmed hypoglycaemic episodes during the last 12 weeks of treatment are presented. Missing values are imputed by LOCF.
Week 26
Participants Who Achieved HbA1c ≤ 6.5% Without Severe or BG Confirmed Hypoglycaemic Episodes
Time Frame: Week 26
Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a PG value < 3.1 mmol/L with or without symptoms consistent with hypoglycaemia. 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 7 calendar days after the last day on trial product. Number of participants who achieved IDF HbA1c target (HbA1c ≤ 6.5%) (yes/no) after 26 weeks of treatment and without severe or BG confirmed hypoglycaemic episodes during the last 12 weeks of treatment are presented. Missing values are imputed by LOCF.
Week 26
Participants Who Achieved HbA1c < 7.0% Without Severe or BG Confirmed Episodes, and Change From Baseline in Body Weight Below or Equal to Zero.
Time Frame: Week 26
Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a PG value < 3.1 mmol/L with or without symptoms consistent with hypoglycaemia. 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 7 calendar days after the last day on trial product. Number of participants who achieved ADA HbA1c target (HbA1c < 7.0%) (yes/no) after 26 weeks of treatment without severe or BG confirmed hypoglycaemic episodes during the last 12 weeks of treatment and with change from baseline in body weight below or equal to zero are presented. Missing values are imputed by LOCF.
Week 26
Participants Who Achieved HbA1c ≤ 6.5% Without Severe or BG Confirmed Episodes and Change From Baseline in Body Weight Below or Equal to Zero.
Time Frame: Week 26
Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a PG value < 3.1 mmol/L with or without symptoms consistent with hypoglycaemia. 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 7 calendar days after the last day on trial product. Number of participants who achieved IDF HbA1c target (HbA1c ≤ 6.5%) (yes/no) after 26 weeks of treatment without severe or BG confirmed hypoglycaemic episodes during the last 12 weeks of treatment and with change from baseline in body weight below or equal to zero are presented. Missing values are imputed by LOCF.
Week 26
Change in Fasting Plasma Glucose (FPG)
Time Frame: Week 0, week 26
Change from baseline (week 0) in FPG after 26 weeks of treatment is presented.
Week 0, week 26
Change in Waist Circumferance
Time Frame: Week 0, week 26
Change from baseline (week 0) in waist circumferance after 26 weeks of treatment is presented.
Week 0, week 26
9-point SMPG Profile
Time Frame: Week 26
Participants measured their PG levels using blood glucose meters at 9 time points (before breakfast, 90 minutes after the start of breakfast, before lunch, 90 minutes after the start of lunch, before dinner, 90 minutes after the start of dinner, at bedtime, at 4 am, before breakfast the following day). 9-point SMPG values at 26 weeks of treatment are presented.
Week 26
Change in Mean of 9-point SMPG Profile
Time Frame: Week 0, week 26
Participants measured their PG levels using blood glucose meters at 9 time points (before breakfast, 90 minutes after the start of breakfast, before lunch, 90 minutes after the start of lunch, before dinner, 90 minutes after the start of dinner, at bedtime, at 4 am, before breakfast the following day). The mean of profile is defined as the area under the profile divided by measurement time and is calculated using the trapezoidal method. Change in mean of the 9-point SMPG profile from baseline (week 0) to week 26 is presented.
Week 0, week 26
Change in Mean Post-prandial Plasma Glucose (PG) Increments
Time Frame: Week 0, week 26
Participants measured their PG levels using blood glucose meters at 9 time points (before breakfast, 90 minutes after the start of breakfast, before lunch, 90 minutes after the start of lunch, before dinner, 90 minutes after the start of dinner, at bedtime, at 4 am, before breakfast the following day). Post-prandial SMPG increments from before meal to 90 minutes after for breakfast, lunch and dinner were calculated. The mean increment over all meals was derived as the mean of all available meal increments. Change from baseline (week 0) in post-prandial SMPG increments for all meals after 26 weeks of treatment is presented.
Week 0, week 26
Change in Fasting C-peptide - Ratio to Baseline
Time Frame: Week 0, week 26
Change in fasting C-peptide (measured in nanomoles per liter [nmol/L]) from baseline (week 0) to week 26 is presented as ratio to baseline.
Week 0, week 26
Change in Fasting Human Insulin - Ratio to Baseline
Time Frame: Week 0, week 26
Change in fasting human insulin (measured in picomoles per liter [pmol/L]) from baseline (week 0) to week 26 is presented as ratio to baseline.
Week 0, week 26
Change in Fasting Glucagon - Ratio to Baseline
Time Frame: Week 0, week 26
Change in fasting glucagon (measured in picograms per milliliter [pg/mL]) from baseline (week 0) to week 26 is presented as ratio to baseline.
Week 0, week 26
Change in HOMA-B (Beta Cell Function)- Ratio to Baseline
Time Frame: Week 0, week 26
Change in HOMA-B (measured in %) from baseline (week 0) to week 26 is presented as ratio to baseline.
Week 0, week 26
Change in Fasting Total Cholesterol - Ratio to Baseline
Time Frame: Week 0, week 26
Change in fasting total cholesterol (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline.
Week 0, week 26
Change in Fasting High Density Lipoprotein (HDL) Cholesterol- Ratio to Baseline
Time Frame: Week 0, week 26
Change in fasting HDL cholesterol (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline
Week 0, week 26
Change in Fasting Low Density Lipoprotein (LDL) Cholesterol- Ratio to Baseline
Time Frame: Week 0, week 26
Change in fasting LDL cholesterol (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline.
Week 0, week 26
Change in Fasting Very Low-density Lipoprotein (VLDL) Cholesterol- Ratio to Baseline
Time Frame: Week 0, week 26
Change in fasting VLDL cholesterol (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline
Week 0, week 26
Change in Fasting Triglycerides - Ratio to Baseline.
Time Frame: Week 0, week 26
Change in fasting triglycerides (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline.
Week 0, week 26
Change in Fasting Free Fatty Acid - Ratio to Baseline
Time Frame: Week 0, week 26
Change in fasting free fatty acid (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline.
Week 0, week 26
Number of Treatment-emergent Adverse Events (TEAE)
Time Frame: Weeks 0-26
A TEAE was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. The observed rates of adverse events (AEs) per patient years of exposure (PYE) (number of AEs divided by PYE multiplied by 100) after 26 weeks are presented.
Weeks 0-26
Number of Treatment Emergent Nocturnal Severe or BG Confirmed Hypoglycaemic Episodes.
Time Frame: Weeks 0-26
Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a PG value < 3.1 mmol/L with or without symptoms consistent with hypoglycaemia. 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 7 calendar days after the last day on trial product. Hypoglycaemic episodes were defined as nocturnal if the time of the onset was between 00:01 and 05.59 both inclusive. The number of episodes are represented as rates. The observed rates of episodes per PYE (number of episodes divided by PYE multiplied by 100) after 26 weeks of treatment are presented.
Weeks 0-26
Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes.
Time Frame: Weeks 0-26
Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a PG value <3.1 mmol/L with symptoms consistent with hypoglycaemia. 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 7 calendar days after the last day on trial product. The number of episodes are represented as rates. The observed rates of episodes per PYE (number of episodes divided by PYE multiplied by 100) after 26 weeks of treatment are presented.
Weeks 0-26
Number of Treatment Emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes
Time Frame: Weeks 0-26
Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a PG value <3.1 mmol/L with symptoms consistent with hypoglycaemia. 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 7 calendar days after the last day on trial product. Hypoglycaemic episodes were defined as nocturnal if the time of the onset was between 00:01 and 05.59 both inclusive. The number of episodes are represented as rates. The observed rates of episodes per PYE (number of episodes divided by PYE multiplied by 100) after 26 weeks of treatment are presented.
Weeks 0-26
Number of Treatment Emergent Hypoglycaemic Episodes According to ADA Definition
Time Frame: Weeks 0-26
A hypoglycaemic episode was 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 7 days after the last day on trial product. The number of episodes are represented as rates. The observed rates of episodes (according to the ADA definition) per PYE (number of episodes divided by PYE multiplied by 100) after 26 weeks of treatment are presented.
Weeks 0-26
Change in Physical Examination
Time Frame: Week -2, week 26
Physical examination parameters are categorised as cardiovascular system; central and peripheral nervous system; gastrointestinal system including mouth; general appearance; head, ears, eyes, nose, throat, neck; lymph node palpation; musculoskeletal system; respiratory system; skin and thyroid gland. The number of participants assessed as normal, abnormal not clinically significant (NCS) and abnormal clinically significant (CS) at screening (week -2) and week 26 per each category is presented.
Week -2, week 26
Eye Examination
Time Frame: Week -2, Week 26
Dilated fundoscopy or fundus photography was performed by the investigator at screening (week -2) and week 26. The results of the examination were interpreted for each eye (left and right) and are categorised as normal, abnormal NCS or abnormal CS. Number of participants in each category at screening (week -2) and week 26 is presented.
Week -2, Week 26
Change in Electrocardiogram (ECG)
Time Frame: Week -2, week 26
Electrocardiogram was assessed by the investigator as normal, abnormal NCS and abnormal CS. Number of participants at screening (week -2) and at week 26 is presented.
Week -2, week 26
Change in Pulse
Time Frame: Week 0, week 26
Change in pulse from baseline (week 0) after 26 weeks of treatment is presented
Week 0, week 26
Change in Blood Pressure (Systolic and Diastolic Blood Pressure)
Time Frame: Week 0, week 26
Change in blood pressure (systolic and diastolic blood pressure) from baseline (week 0) after 26 weeks of treatment is presented
Week 0, week 26
Change in Biochemistry Parameters: Alkaline Phosphatase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase, Amalyse, Lipase, Creatiine Kinase Serum
Time Frame: Week 0, week 26
Change in alkaline phosphatase, ALT, AST, creatine kinase, amylase, lipase, creatine kinase serum from baseline (week 0) after 26 weeks of treatment is presented.
Week 0, week 26
Change in Biochemistry Parameters (Albumin Serum, Total Protein)
Time Frame: Week 0, week 26
Change in total protein, albumin serum from baseline (week 0) after 26 weeks of treatment is presented.
Week 0, week 26
Change in Biochemistry Parameters: Calcium Serum (Total), Calcium Corrected Serum, Potassium Serum, Sodium Serum, Urea Serum
Time Frame: Week 0, week 26
Change in calcium serum (total), calcium corrected serum, potassium serum, sodium serum, urea serum from baseline (week 0) after 26 weeks of treatment is presented.
Week 0, week 26
Change in Biochemistry Parameters: Total Bilirubin Serum, Creatinine Serum
Time Frame: Week 0, week 26
Change in total bilirubin serum, creatinine serum from baseline (week 0) after 26 weeks of treatment is presented.
Week 0, week 26
Change in Haematological Parameter: Erythrocytes Blood
Time Frame: Week 0, week 26
Change in erythrocyte blood from baseline (week 0) after 26 weeks of treatment is presented.
Week 0, week 26
Change in Haematological Parameter: Haematocrits
Time Frame: Week 0, week 26
Change in haematocrits from baseline (week 0) after 26 weeks of treatment is presented.
Week 0, week 26
Change in Haemotological Parameter- Eosinophils
Time Frame: Week 0, week 26
Change in eosinophils from baseline after 26 weeks of treatment is presented.
Week 0, week 26
Change in Haematological Parameter - Neutrophils
Time Frame: Week 0, week 26
Change in neutrophils from baseline (week 0) after 26 weeks of treatment is presented.
Week 0, week 26
Change in Haematological Parameter: Basophils
Time Frame: Week 0, week 26
Change in basophils from baseline (week 0) after 26 weeks of treatment is presented.
Week 0, week 26
Change in Haemotological Parameter- Monocytes
Time Frame: Week 0, week 26
Change in monocytes from baseline (week 0) after 26 weeks of treatment is presented
Week 0, week 26
Change in Haematological Parameter - Lymphocytes
Time Frame: Week 0, week 26
Change in lymphocytes from baseline (week 0) after 26 weeks of treatment is presented
Week 0, week 26
Change in Haematology: Haemoglobin Blood
Time Frame: Week 0, week 26
Change in haemoglobin from baseline (week 0) after 26 weeks of treatment is presented.
Week 0, week 26
Change in Haematologcal Parameter: Leukocytes
Time Frame: Week 0, week 26
Change in leukocytes from baseline (week 0) after 26 weeks of treatment
Week 0, week 26
Change in Haematological Parameter: Thrombocytes
Time Frame: Week 0, week 26
Change in thrombocytes from baseline (week 0) after 26 weeks of treatment
Week 0, week 26
Change in Calcitonin
Time Frame: Week 0, week 26
Calcitonin levels were measured and were categorised as low, normal or high in relation to reference range (8.31- 14.3 picogram/milliliter [pg/mL]). Number of participants in each category at baseline (week 0) and week 26 are presented.
Week 0, week 26
Urinalysis (Protein, Glucose, Erythrocytes and Ketones)
Time Frame: Week 0, week 26
The urinalysis assessment was the measurements of protein, glucose, erythrocytes and ketones in urine at baseline (week 0) and week 26 and categorised as negative, trace and positive. Number of participants in each category at week 0 and week 26 is presented.
Week 0, week 26
Occurence of Anti-insulin Degludec Specific Antibodies
Time Frame: Week 27
This outcome measure is only applicable for the insulin degludec/liraglutide arm and insulin degludec arm. Serum samples were analysed for the presence of anti-insulin degludec specific antibodies. Results at week 27 are presented as percentage of bound radioactive-labelled insulin (B) /total radioactive-labelled insulin added to the samples (T).
Week 27
Occurence of Antibodies Cross-reacting to Human Insulin
Time Frame: Week 27
This outcome measure is only applicable for the insulin degludec/liraglutide arm and insulin degludec arm. Serum samples were analysed for the presence of cross-reacting antibodies to human insulin. Results at week 27 are presented as percentage of bound radioactive-labelled insulin (B) /total radioactive-labelled insulin added to the samples (T).
Week 27
Occurence of Total Insulin Antibodies
Time Frame: Week 27
This outcome measure is only applicable for the Insulin degludec/liraglutide arm and Insulin degludec arm. Serum samples were analysed for the presence of antobodies to human insulin. Results at week 27 are presented as percentage of bound radioactive-labelled insulin (B) /total radioactive-labelled insulin added to the samples (T).
Week 27
Occurence of Anti-liraglutide Antibodies
Time Frame: Week 27
This outcome measure is applicable for the Insulin degludec/liraglutide arm and the liraglutide arm. Serum samples were analysed for the presence of anti-liraglutide antibodies. Number of participants who were assessed for anti-liraglutide antibodies at week 27 are presented.
Week 27
Occurence of Antibodies Cross-reacting to Native Glucagon-like Peptide (GLP-1)
Time Frame: Week 27
This outcome measure is applicable to the Insulin degludec/liraglutide arm and the liraglutide arm. Serum samples were analysed for the presence of cross-reacting antibodies to native GLP-1. Number of participants who measured with anti-liraglutide antibodies cross reacting native GLP-1 at week 27 are presented.
Week 27
Occurence of Neutralising Liraglutide Antibodies
Time Frame: Week 27
This outcome measure is only applicable for the Insulin degludec/liraglutide arm and liraglutide arm. Neutralising antibodies were assessed when the corresponding anti-Liraglutide antibody were positive at week 27. Number of participants who measured with neutralising liraglutide antibodies at week 27 are presented.
Week 27
Occurence of Neutralising Antibodies Cross-reacting to Native GLP-1
Time Frame: Week 27
This outcome measure is only applicable for the Insulin degludec/liraglutide arm and liraglutide arm. Cross reacting antibodies were assessed when anti-liraglutide antibody was positive. Number of participants who measured with neutralising liraglutide antibodies cross-reacting to native GLP-1 at week 27 are presented.
Week 27
Serum Concentrations of Insulin Degludec
Time Frame: Week 0, week 26
This outcome measure is applicable for Insulin degludec and Insulin degludec/liraglutide arms. Serum samples from the Insulin degludec/liraglutide and Insulin degludec arms were assayed using population PK analysis. The maximum serum concentrations (Cmax) are summarised for the two arms.
Week 0, week 26
Plasma Concentration of Liraglutide
Time Frame: Week 0, week 26
This outcome measure is for Insulin degludec/liraglutide and liraglutide arms. Serum samples from the Insulin degludec/liraglutide and liraglutide arms were assayed using population PK analysis. The Cmax are summarised for the two arms.
Week 0, week 26

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

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.
May 26, 2017

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.
June 14, 2019

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.
July 13, 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 24, 2017

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 29, 2017

First Posted (Actual)

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.
June 1, 2017

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.
December 14, 2022

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.
November 18, 2022

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.
November 1, 2022

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.
  • NN9068-4148
  • U1111-1154-6671 (Other Identifier: World Health Organization (WHO))
  • CTR20170004 (Registry Identifier: China Drug Trials (China))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

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