A Clinical Trial Comparing Efficacy and Safety of Insulin Degludec/Liraglutide (IDegLira) Versus Basal-bolus Therapy in Subjects With Type 2 Diabetes Mellitus

March 1, 2018 updated by: Novo Nordisk A/S
This trial is conducted globally. The aim of this trial is to compare efficacy and safety of insulin degludec/liraglutide (IDegLira) versus basal-bolus therapy in combination with metformin in subjects with type 2 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.
506

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

  • Argentina
      • Caba, Argentina, C1440AAD
        • Novo Nordisk Investigational Site
      • Capital Federal, Argentina, 1405
        • Novo Nordisk Investigational Site
      • Córdoba, Argentina, X5006IKK
        • Novo Nordisk Investigational Site
      • Salta, Argentina, 4400
        • Novo Nordisk Investigational Site
  • Czechia
      • Brno, Czechia, 65691
        • Novo Nordisk Investigational Site
      • Hradec Králové, Czechia, 500 36
        • Novo Nordisk Investigational Site
      • Olomouc, Czechia, 77900
        • Novo Nordisk Investigational Site
      • Olomouc, Lazce, Czechia, 77900
        • Novo Nordisk Investigational Site
      • Pardubice, Czechia, 53002
        • Novo Nordisk Investigational Site
      • Prostejov, Czechia, 79601
        • Novo Nordisk Investigational Site
  • France
      • Angers, France, 49000
        • Novo Nordisk Investigational Site
      • Bourgoin-jallieu, France, 38302
        • Novo Nordisk Investigational Site
      • Brest, France, 29609
        • Novo Nordisk Investigational Site
      • LA ROCHELLE cedex, France, 17019
        • Novo Nordisk Investigational Site
      • Le Coudray, France, 28630
        • Novo Nordisk Investigational Site
      • Le Creusot, France, 71200
        • Novo Nordisk Investigational Site
      • MARSEILLE cedex 08, France, 13285
        • Novo Nordisk Investigational Site
      • Marseille, France, 13008
        • Novo Nordisk Investigational Site
      • Saint Herblain, France, 44800
        • Novo Nordisk Investigational Site
      • Saint Priest en Jarez, France, 42270
        • Novo Nordisk Investigational Site
      • Strasbourg, France, 67098
        • Novo Nordisk Investigational Site
      • Venissieux, France, 69200
        • Novo Nordisk Investigational Site
  • Greece
      • Athens, Greece, GR-11527
        • Novo Nordisk Investigational Site
      • Chalkida, Evia, Greece, GR-34100
        • Novo Nordisk Investigational Site
      • Ioannina, Greece, 45500
        • Novo Nordisk Investigational Site
      • Larissa, Greece, GR-41110
        • Novo Nordisk Investigational Site
      • Thessaloniki, Greece, GR-57001
        • Novo Nordisk Investigational Site
      • Thessaloniki, Greece, GR-54642
        • Novo Nordisk Investigational Site
  • Hungary
      • Budapest, Hungary, 1115
        • Novo Nordisk Investigational Site
      • Gyula, Hungary, H-5700
        • Novo Nordisk Investigational Site
      • Szeged, Hungary, H-6720
        • Novo Nordisk Investigational Site
      • Szombathely, Hungary, H-9700
        • Novo Nordisk Investigational Site
      • Tatabánya, Hungary, 2800
        • Novo Nordisk Investigational Site
  • Israel
      • Haifa, Israel, 35152
        • Novo Nordisk Investigational Site
      • Holon, Israel, 58100
        • Novo Nordisk Investigational Site
      • Jerusalem, Israel, 91120
        • Novo Nordisk Investigational Site
      • Kfar Saba, Israel, 44281
        • Novo Nordisk Investigational Site
      • Nahariya, Israel, 22100
        • Novo Nordisk Investigational Site
      • Rehovot, Israel, 76100
        • Novo Nordisk Investigational Site
  • Mexico
      • Aguascalientes, Mexico, 20230
        • Novo Nordisk Investigational Site
      • Durango, Mexico, 34000
        • Novo Nordisk Investigational Site
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44650
        • Novo Nordisk Investigational Site
    • México, D.F.
      • Mexico City, México, D.F., Mexico, 03300
        • Novo Nordisk Investigational Site
  • Russian Federation
      • Kazan, Russian Federation, 420073
        • Novo Nordisk Investigational Site
      • Moscow, Russian Federation, 117036
        • Novo Nordisk Investigational Site
      • Saint-Petersburg, Russian Federation, 199034
        • Novo Nordisk Investigational Site
      • Saint-Petersburg, Russian Federation, 191119
        • Novo Nordisk Investigational Site
      • Saint-Petersburg, Russian Federation, 194354
        • Novo Nordisk Investigational Site
      • Saint-Petersburg, Russian Federation, 194291
        • Novo Nordisk Investigational Site
      • Volgograd, Russian Federation, 400131
        • Novo Nordisk Investigational Site
  • Slovakia
      • Bardejov, Slovakia, 08501
        • Novo Nordisk Investigational Site
      • Dolny Kubin, Slovakia, 02601
        • Novo Nordisk Investigational Site
      • Malacky, Slovakia, 90101
        • Novo Nordisk Investigational Site
      • Poprad, Slovakia, 05801
        • Novo Nordisk Investigational Site
      • Roznava, Slovakia, 04801
        • Novo Nordisk Investigational Site
  • Spain
      • Almería, Spain, 04001
        • Novo Nordisk Investigational Site
      • Fuenlabrada - Madrid, Spain, 28942
        • Novo Nordisk Investigational Site
      • Pozuelo de Alarcon, Spain, 28223
        • Novo Nordisk Investigational Site
      • Sevilla, Spain, 41010
        • Novo Nordisk Investigational Site
      • Sevilla, Spain, 41003
        • Novo Nordisk Investigational Site
      • Valencia, Spain, 46026
        • Novo Nordisk Investigational Site
  • Turkey
      • Ankara, Turkey, 06110
        • Novo Nordisk Investigational Site
      • Ankara, Turkey, 06100
        • Novo Nordisk Investigational Site
      • Antalya, Turkey, 07058
        • Novo Nordisk Investigational Site
      • Istanbul, Turkey, 34096
        • Novo Nordisk Investigational Site
      • Istanbul, Turkey, 34303
        • Novo Nordisk Investigational Site
      • Istanbul, Turkey, 34371
        • Novo Nordisk Investigational Site
  • United States
    • Alabama
      • Tuscumbia, Alabama, United States, 35674
        • Novo Nordisk Investigational Site
    • California
      • Anaheim, California, United States, 92801
        • Novo Nordisk Investigational Site
      • Bermuda Dunes, California, United States, 92203
        • Novo Nordisk Investigational Site
      • Fresno, California, United States, 93720
        • Novo Nordisk Investigational Site
      • Lancaster, California, United States, 93534
        • Novo Nordisk Investigational Site
      • Lincoln, California, United States, 95648
        • Novo Nordisk Investigational Site
      • Lomita, California, United States, 90717
        • Novo Nordisk Investigational Site
      • Los Angeles, California, United States, 90057
        • Novo Nordisk Investigational Site
      • Montclair, California, United States, 91763
        • Novo Nordisk Investigational Site
      • Northridge, California, United States, 91325
        • Novo Nordisk Investigational Site
      • San Mateo, California, United States, 94401
        • Novo Nordisk Investigational Site
      • Ventura, California, United States, 93003
        • Novo Nordisk Investigational Site
    • Connecticut
      • Waterbury, Connecticut, United States, 06708
        • Novo Nordisk Investigational Site
    • Florida
      • Palm Harbor, Florida, United States, 34684-3609
        • Novo Nordisk Investigational Site
      • Plantation, Florida, United States, 33324
        • Novo Nordisk Investigational Site
    • Idaho
      • Blackfoot, Idaho, United States, 83221
        • Novo Nordisk Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Novo Nordisk Investigational Site
      • Skokie, Illinois, United States, 60077
        • Novo Nordisk Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46254
        • Novo Nordisk Investigational Site
    • Louisiana
      • Metairie, Louisiana, United States, 70002
        • Novo Nordisk Investigational Site
      • Natchitoches, Louisiana, United States, 71457-5881
        • Novo Nordisk Investigational Site
      • Shreveport, Louisiana, United States, 71105
        • Novo Nordisk Investigational Site
    • Maryland
      • Rockville, Maryland, United States, 20852
        • Novo Nordisk Investigational Site
    • Massachusetts
      • Waltham, Massachusetts, United States, 02453
        • Novo Nordisk Investigational Site
    • Montana
      • Billings, Montana, United States, 59101
        • Novo Nordisk Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89109
        • Novo Nordisk Investigational Site
      • Las Vegas, Nevada, United States, 89128
        • Novo Nordisk Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Novo Nordisk Investigational Site
    • New York
      • Albany, New York, United States, 12206
        • Novo Nordisk Investigational Site
      • Jackson Heights, New York, United States, 11372
        • Novo Nordisk Investigational Site
      • New Windsor, New York, United States, 12553
        • Novo Nordisk Investigational Site
      • West Seneca, New York, United States, 14224
        • Novo Nordisk Investigational Site
    • North Carolina
      • Shelby, North Carolina, United States, 28150
        • Novo Nordisk Investigational Site
      • Statesville, North Carolina, United States, 28625
        • Novo Nordisk Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45245
        • Novo Nordisk Investigational Site
      • Columbus, Ohio, United States, 43213
        • Novo Nordisk Investigational Site
      • Dayton, Ohio, United States, 45439
        • Novo Nordisk Investigational Site
      • Mason, Ohio, United States, 45040-6815
        • Novo Nordisk Investigational Site
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16602
        • Novo Nordisk Investigational Site
      • Philadelphia, Pennsylvania, United States, 19152
        • Novo Nordisk Investigational Site
    • South Carolina
      • Greer, South Carolina, United States, 29651
        • Novo Nordisk Investigational Site
      • Murrells Inlet, South Carolina, United States, 29576
        • Novo Nordisk Investigational Site
    • Tennessee
      • Kingsport, Tennessee, United States, 37660
        • Novo Nordisk Investigational Site
    • Texas
      • Houston, Texas, United States, 77024
        • Novo Nordisk Investigational Site
      • Houston, Texas, United States, 77058
        • Novo Nordisk Investigational Site
      • San Antonio, Texas, United States, 78229
        • Novo Nordisk Investigational Site
      • Sugar Land, Texas, United States, 77478
        • Novo Nordisk Investigational Site
      • Sugar Land, Texas, United States, 77479
        • Novo Nordisk Investigational Site
    • Virginia
      • Midlothian, Virginia, United States, 23114
        • Novo Nordisk Investigational Site
    • Washington
      • Spokane, Washington, United States, 99208
        • 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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female, age at least 18 years at the time of signing informed consent
  • Type 2 diabetes subjects (diagnosed clinically) at least 6 months prior to screening
  • HbA1c (glycosylated haemoglobin) 7.0-10.0% [53mmol/mol-86mmol/mol] (both inclusive) by central laboratory analysis
  • Current treatment with IGlar (insulin glargine) for at least 90 calendar days prior to screening
  • Stable daily dose of IGlar between 20 units and 50 units (both inclusive) for at least 56 calendar days prior to screening. Individual fluctuations of plus/minus 10% within the 56 calendar days prior to screening are acceptable, however on the day of screening total daily dose should be within the range of 20 units-50 units both inclusive
  • Stable daily dose of metformin (at least 1500 mg or max tolerated dose) for at least 90 calendar days prior to screening
  • Body mass index (BMI) below or equal to 40 kg/m^2

Exclusion Criteria:

  • Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 calendar days before screening
  • Anticipated initiation or change in concomitant medications in excess of 14 calendar days known to affect weight or glucose metabolism, such as weight loss/modifying (e.g.; sibutramine, orlistat, thyroid hormones, corticosteroids)
  • Impaired liver function, defined as alanine aminotransferase (ALT) at least 2.5 times upper limit of normal
  • Renal impairment eGFR (electronic case report form) below 60 mL/min/1.73 m^2 as per CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration)
  • Screening calcitonin at least 50 ng/L
  • History of pancreatitis (acute or chronic)
  • Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2

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.
Experimental: IDegLira
Drug: insulin degludec/liraglutide
Once daily injected s.c./subcutaneously (under the skin) in combination with metformin.
Active Comparator: IGlar plus IAsp
Drug: insulin glargine
Once daily injected s.c./subcutaneously (under the skin) in combination with metformin.
Drug: insulin aspart
Injected s.c./subcutaneously (under the skin) before each main meal.

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 (Glycosylated Haemoglobin)
Time Frame: Week 0, Week 26
Change in HbA1c values after 26 weeks of treatment.
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
Number of Treatment Emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes.
Time Frame: Weeks 0-26
Severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe and/or BG confirmed by a plasma glucose value of <56 mg/dL (3.1 mmol/L), with symptoms consistent with hypoglycaemia.
Weeks 0-26
Change in Body Weight
Time Frame: Week 0, Week 26
Change in body weight after 26 weeks of treatment.
Week 0, Week 26
Responder for HbA1c Below 7.0%
Time Frame: After 26 weeks of treatment
Number of subjects with HbA1c below 7% after 26 weeks of treatment.
After 26 weeks of treatment
Responder for HbA1c Below or Equal to 6.5 %
Time Frame: After 26 weeks of treatment
Number of subjects with HbA1c below 6.5% after 26 weeks of treatment.
After 26 weeks of treatment

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.
July 26, 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.
October 5, 2016

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.
October 5, 2016

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).
April 8, 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.
April 14, 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.
April 17, 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.
March 29, 2018

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 1, 2018

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.
February 1, 2018

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.
  • NN9068-4185
  • 2014-003621-18 (EudraCT Number)
  • U1111-1160-6923 (Other Identifier: WHO)
  • REec-2015-1682 (Registry Identifier: 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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