Effect of Liraglutide or Exenatide Added to an Ongoing Treatment on Blood Glucose Control in Subjects With Type 2 Diabetes (LEAD-6)

January 25, 2017 updated by: Novo Nordisk A/S

Effect of Liraglutide or Exenatide Added to a Background Treatment of Metformin, Sulphonylurea or a Combination of Both on Glycaemic Control in Subjects With Type 2 Diabetes

This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to compare the effect on glycaemic control of liraglutide or exenatide when added to subject's ongoing OAD (oral anti-diabetic drug) treatment of either metformin, sulphonylurea or a combination of both in subjects with type 2 diabetes. Two trial periods: A 26 week randomised, followed by a 52 week extension (14 + 38 weeks) where all subjects received liraglutide + OAD after previous randomisation to either liraglutide or exenatide, both combined with OAD treatment.

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.
467

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

  • Austria
      • Graz, Austria, 8036
        • Novo Nordisk Investigational Site
      • Wien, Austria, 1130
        • Novo Nordisk Investigational Site
      • Wien, Austria, 1030
        • Novo Nordisk Investigational Site
  • Denmark
      • Aalborg, Denmark, 9000
        • Novo Nordisk Investigational Site
      • Gentofte, Denmark, 2820
        • Novo Nordisk Investigational Site
      • Hvidovre, Denmark, 2650
        • Novo Nordisk Investigational Site
      • Odense, Denmark, 5000
        • Novo Nordisk Investigational Site
      • Århus C, Denmark, 8000
        • Novo Nordisk Investigational Site
  • Finland
      • Helsinki, Finland, 00029
        • Novo Nordisk Investigational Site
      • Lahti, Finland, 15110
        • Novo Nordisk Investigational Site
      • Oulu, Finland, FI-90100
        • Novo Nordisk Investigational Site
  • France
      • Antibes, France, 06600
        • Novo Nordisk Investigational Site
      • Dommartin Les Toul, France, 54201
        • Novo Nordisk Investigational Site
      • LA ROCHELLE cedex, France, 17019
        • Novo Nordisk Investigational Site
      • NEVERS cedex, France, 58033
        • Novo Nordisk Investigational Site
      • Narbonne, France, 11108
        • Novo Nordisk Investigational Site
  • Germany
      • Bochum, Germany, 44791
        • Novo Nordisk Investigational Site
      • Dreieich-Sprendlingen, Germany, 63303
        • Novo Nordisk Investigational Site
      • Falkensee, Germany, 14612
        • Novo Nordisk Investigational Site
      • Frankfurt, Germany, 60388
        • Novo Nordisk Investigational Site
      • Hamburg, Germany, 22607
        • Novo Nordisk Investigational Site
      • Hannover, Germany, 30625
        • Novo Nordisk Investigational Site
      • Herrenberg, Germany, 71083
        • Novo Nordisk Investigational Site
      • Lampertheim, Germany, 68623
        • Novo Nordisk Investigational Site
      • Ludwigshafen, Germany, 67059
        • Novo Nordisk Investigational Site
      • Marburg, Germany, 35039
        • Novo Nordisk Investigational Site
      • Pohlheim, Germany, 35415
        • Novo Nordisk Investigational Site
      • Rehlingen-Siersburg, Germany, 66780
        • Novo Nordisk Investigational Site
      • Speyer, Germany, 67346
        • Novo Nordisk Investigational Site
      • Tübingen, Germany, 72072
        • Novo Nordisk Investigational Site
  • Ireland
      • Dublin, Ireland, DUBLIN 7
        • Novo Nordisk Investigational Site
      • Dublin, Ireland, DUBLIN 8
        • Novo Nordisk Investigational Site
      • Dublin 24, Ireland
        • Novo Nordisk Investigational Site
      • Dublin 9, Ireland
        • Novo Nordisk Investigational Site
  • Macedonia, The Former Yugoslav Republic of
      • Skopje, Macedonia, The Former Yugoslav Republic of, 1000
        • Novo Nordisk Investigational Site
  • Norway
      • Bergen, Norway, 5021
        • Novo Nordisk Investigational Site
      • Bergen, Norway, NO-5012
        • Novo Nordisk Investigational Site
      • Stavanger, Norway, 4011
        • Novo Nordisk Investigational Site
      • Trondheim, Norway, NO-7030
        • Novo Nordisk Investigational Site
  • Poland
      • Bydgoszcz, Poland, 85-822
        • Novo Nordisk Investigational Site
      • Gniewkowo, Poland, 88-140
        • Novo Nordisk Investigational Site
      • Krakow, Poland, 31-501
        • Novo Nordisk Investigational Site
      • Lublin, Poland, 20-081
        • Novo Nordisk Investigational Site
      • Poznan, Poland, 60-821
        • Novo Nordisk Investigational Site
      • Tychy, Poland, 43-100
        • Novo Nordisk Investigational Site
      • Warszawa, Poland, 01-911
        • Novo Nordisk Investigational Site
      • Wroclaw, Poland, 50-127
        • Novo Nordisk Investigational Site
      • Zabrze, Poland, 41-800
        • Novo Nordisk Investigational Site
  • Puerto Rico
      • Manati, Puerto Rico, 00674
        • Novo Nordisk Investigational Site
  • Romania
      • Resita, Romania, 320076
        • Novo Nordisk Investigational Site
      • Suceava, Romania, 720237
        • Novo Nordisk Investigational Site
    • Alba
      • Alba Iulia, Alba, Romania, 510053
        • Novo Nordisk Investigational Site
  • Slovenia
      • Koper, Slovenia, SI-6000
        • Novo Nordisk Investigational Site
      • Ljubljana, Slovenia, 1525
        • Novo Nordisk Investigational Site
      • Novo mesto, Slovenia, 8000
        • Novo Nordisk Investigational Site
  • Spain
      • Hospitalet de Llobregat, Spain, 08907
        • Novo Nordisk Investigational Site
      • Oviedo, Spain, 33006
        • Novo Nordisk Investigational Site
      • Palma de Mallorca, Spain, 07010
        • Novo Nordisk Investigational Site
      • Puerto del Rosario, Spain, 35600
        • Novo Nordisk Investigational Site
  • Sweden
      • Stockholm, Sweden, 171 76
        • Novo Nordisk Investigational Site
      • Stockholm, Sweden, 141 86
        • Novo Nordisk Investigational Site
  • Switzerland
      • Basel, Switzerland, 4031
        • Novo Nordisk Investigational Site
      • Bern, Switzerland, 3010
        • Novo Nordisk Investigational Site
      • Genève 14, Switzerland, 1211
        • Novo Nordisk Investigational Site
      • Lugano, Switzerland, 6900
        • Novo Nordisk Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35242
        • Novo Nordisk Investigational Site
    • Arizona
      • Goodyear, Arizona, United States, 85395
        • Novo Nordisk Investigational Site
    • California
      • Artesia, California, United States, 90701
        • Novo Nordisk Investigational Site
      • Encino, California, United States, 91436
        • Novo Nordisk Investigational Site
      • Escondido, California, United States, 92025
        • Novo Nordisk Investigational Site
      • Los Angeles, California, United States, 90057
        • Novo Nordisk Investigational Site
      • Orange, California, United States, 92869
        • Novo Nordisk Investigational Site
      • Sacramento, California, United States, 95816
        • Novo Nordisk Investigational Site
      • San Mateo, California, United States, 94401
        • Novo Nordisk Investigational Site
      • Spring Valley, California, United States, 91978
        • Novo Nordisk Investigational Site
      • Walnut Creek, California, United States, 94598
        • Novo Nordisk Investigational Site
    • Florida
      • Fort Myers, Florida, United States, 33907
        • Novo Nordisk Investigational Site
      • Hollywood, Florida, United States, 33023
        • Novo Nordisk Investigational Site
      • Jacksonville, Florida, United States, 32216
        • Novo Nordisk Investigational Site
      • Jacksonville, Florida, United States, 32205
        • Novo Nordisk Investigational Site
      • Jacksonville, Florida, United States, 32259
        • Novo Nordisk Investigational Site
      • Longwood, Florida, United States, 32779
        • Novo Nordisk Investigational Site
      • Ocala, Florida, United States, 34471
        • Novo Nordisk Investigational Site
      • Pembroke Pines, Florida, United States, 33029
        • Novo Nordisk Investigational Site
      • Plantation, Florida, United States, 33324
        • Novo Nordisk Investigational Site
      • St. Cloud, Florida, United States, 34769
        • Novo Nordisk Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30318
        • Novo Nordisk Investigational Site
      • Powder Springs, Georgia, United States, 30127
        • Novo Nordisk Investigational Site
      • Roswell, Georgia, United States, 30076
        • Novo Nordisk Investigational Site
    • Idaho
      • Idaho Falls, Idaho, United States, 83404-7596
        • Novo Nordisk Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60616
        • Novo Nordisk Investigational Site
      • Peoria, Illinois, United States, 61615
        • Novo Nordisk Investigational Site
    • Indiana
      • Evansville, Indiana, United States, 47714
        • Novo Nordisk Investigational Site
    • Iowa
      • Des Moines, Iowa, United States, 50314-3027
        • Novo Nordisk Investigational Site
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Novo Nordisk Investigational Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55416
        • Novo Nordisk Investigational Site
      • St. Paul, Minnesota, United States, 55108
        • Novo Nordisk Investigational Site
    • Missouri
      • St. Peters, Missouri, United States, 63376
        • Novo Nordisk Investigational Site
    • New Jersey
      • Flemington, New Jersey, United States, 08822
        • Novo Nordisk Investigational Site
      • South Bound Brook, New Jersey, United States, 08880
        • Novo Nordisk Investigational Site
    • New York
      • Northport, New York, United States, 11768
        • Novo Nordisk Investigational Site
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27517
        • Novo Nordisk Investigational Site
    • Ohio
      • Canton, Ohio, United States, 44718
        • Novo Nordisk Investigational Site
      • Cincinnati, Ohio, United States, 45206
        • Novo Nordisk Investigational Site
      • Dayton, Ohio, United States, 45439
        • Novo Nordisk Investigational Site
      • Kettering, Ohio, United States, 45429
        • Novo Nordisk Investigational Site
      • Mentor, Ohio, United States, 44060
        • Novo Nordisk Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • Novo Nordisk Investigational Site
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16602
        • Novo Nordisk Investigational Site
      • Philadelphia, Pennsylvania, United States, 19152
        • Novo Nordisk Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15213
        • Novo Nordisk Investigational Site
    • South Carolina
      • Sumter, South Carolina, United States, 29150
        • Novo Nordisk Investigational Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Novo Nordisk Investigational Site
    • Texas
      • Austin, Texas, United States, 78731
        • Novo Nordisk Investigational Site
      • Corpus Christi, Texas, United States, 78412
        • Novo Nordisk Investigational Site
      • Dallas, Texas, United States, 75230
        • Novo Nordisk Investigational Site
      • Dallas, Texas, United States, 75231
        • Novo Nordisk Investigational Site
      • Dallas, Texas, United States, 75246
        • Novo Nordisk Investigational Site
      • Houston, Texas, United States, 77030
        • Novo Nordisk Investigational Site
      • Midland, Texas, United States, 79707
        • Novo Nordisk Investigational Site
      • San Antonio, Texas, United States, 78229
        • Novo Nordisk Investigational Site
    • Virginia
      • Newport News, Virginia, United States, 23606
        • Novo Nordisk Investigational Site
      • Richmond, Virginia, United States, 23294
        • Novo Nordisk Investigational Site
    • Washington
      • Olympia, Washington, United States, 98502
        • Novo Nordisk Investigational Site
      • Spokane, Washington, United States, 99218
        • Novo Nordisk Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53209
        • 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 to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 2 diabetes
  • Stable treatment with Oral Anti-Diabetic Drugs (metformin, sulphonylurea or a combination of both) for at least 3 months at the discretion of the Investigator
  • HbA1C equal to or greater than 7.0% and equal to or lower than 11.0%
  • Body Mass Index (BMI) equal to or lower than 45.0 kg/m2

Exclusion Criteria:

  • Previous treatment with insulin
  • Treatment with any anti-diabetic drug other than metformin and sulphonylurea
  • Any previous exposure to exenatide or liraglutide
  • Impaired liver or/and renal function
  • History of any significant cardiac events
  • Known retinopathy or maculopathy requiring acute treatment
  • Recurrent major hypoglycaemia or hypoglycaemic unawareness

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: Liraglutide
Liraglutide 1.8 mg once daily + subject's own OAD treatment
Drug: liraglutide
1.8 mg once daily for s.c. (under the skin) injection.
Active Comparator: Exenatide
Exenatide 10 mcg twice daily + subject's own OAD treatment
Drug: exenatide
10 mcg twice daily for s.c. (under the skin) injection.

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 Glycosylated A1c (HbA1c) at Week 26
Time Frame: week 0, week 26
Percentage point change in glycosylated A1c (HbA1c) from baseline (week 0) to 26 weeks (end of randomisation)
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 Glycosylated A1c (HbA1c), Weeks 26-78
Time Frame: week 26, week 78
Percentage point change in glycosylated A1c (HbA1c) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group)
week 26, week 78
Change in Glycosylated A1c (HbA1c) at Week 78
Time Frame: week 0, week 78
Percentage point change in glycosylated A1c (HbA1c) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group)
week 0, week 78
Percentage of Subjects Achieving Treatment Target of Either HbA1c < 7.0% or =< 6.5% at Week 26
Time Frame: week 0, week 26
Percentage of subjects achieving treatment target of HbA1c less than 7.0% or less than or equal to 6.5% at Week 26 (end of randomisation)
week 0, week 26
Percentage of Subjects Achieving Treatment Target of Either HbA1c < 7.0% or =< 6.5% at Week 78
Time Frame: week 0, week 78
Percentage of subjects achieving treatment target of HbA1c less than 7.0% or less than or equal to 6.5% at Week 78 (end of treatment)
week 0, week 78
Change in Body Weight at Week 26
Time Frame: week 0, week 26
Change in body weight from baseline (week 0) to 26 weeks (end of randomisation)
week 0, week 26
Change in Body Weight, Weeks 26-78
Time Frame: week 26, week 78
Change in body weight from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group)
week 26, week 78
Change in Body Weight at Week 78
Time Frame: week 0, week 78
Change in body weight from baseline (Week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group)
week 0, week 78
Change in Fasting Plasma Glucose at Week 26
Time Frame: week 0, week 26
Change in fasting plasma glucose (FPG) from baseline (week 0) to 26 weeks (end of randomisation)
week 0, week 26
Change in Fasting Plasma Glucose, Weeks 26-78
Time Frame: week 26, week 78
Change in fasting plasma glucose from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group)
week 26, week 78
Change in Fasting Plasma Glucose at Week 78
Time Frame: week 0, week 78
Change in fasting plasma glucose from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group)
week 0, week 78
Change in Mean Prandial Increment of Plasma Glucose After Breakfast at Week 26
Time Frame: week 0, week 26
Change in mean prandial increment of plasma glucose after breakfast from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between glucose values measured before and after breakfast.
week 0, week 26
Change in Mean Prandial Increment of Plasma Glucose After Lunch at Week 26
Time Frame: week 0, week 26
Change in mean prandial increment of plasma glucose after lunch from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after lunch.
week 0, week 26
Change in Mean Prandial Increment of Plasma Glucose After Dinner at Week 26
Time Frame: week 0, week 26
Change in mean prandial increment of plasma glucose after dinner from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner.
week 0, week 26
Change in Mean Prandial Increment of Plasma Glucose After Breakfast, Weeks 26-78
Time Frame: week 26, week 78
Change in mean prandial increment of plasma glucose after breakfast from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after breakfast.
week 26, week 78
Change in Mean Prandial Increment of Plasma Glucose After Lunch, Weeks 26-78
Time Frame: week 26, week 78
Change in mean prandial increment of plasma glucose after lunch from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after a lunch.
week 26, week 78
Change in Mean Prandial Increment of Plasma Glucose After Dinner, Weeks 26-78
Time Frame: week 26, week 78
Change in mean prandial increment of plasma glucose after dinner from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner.
week 26, week 78
Change in Mean Prandial Increment of Plasma Glucose After Breakfast at Week 78
Time Frame: week 0, week 78
Change in mean prandial increment of plasma glucose after breakfast from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after breakfast.
week 0, week 78
Change in Mean Prandial Increment of Plasma Glucose After Lunch at Week 78
Time Frame: week 0, week 78
Change in mean prandial increment of plasma glucose after lunch from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after lunch.
week 0, week 78
Change in Mean Prandial Increment of Plasma Glucose After Dinner at Week 78
Time Frame: week 0, week 78
Change in mean prandial increment of plasma glucose after dinner from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner.
week 0, week 78
Change in Mean Postprandial Increment of Plasma Glucose After Breakfast at Week 26
Time Frame: week 0, week 26
Change in mean postprandial increment of plasma glucose after breakfast from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after breakfast.
week 0, week 26
Change in Mean Postprandial Increment of Plasma Glucose After Lunch at Week 26
Time Frame: week 0. week 26
Change in mean postprandial increment of plasma glucose after lunch from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after lunch.
week 0. week 26
Change in Mean Postprandial Increment of Plasma Glucose After Dinner at Week 26
Time Frame: week 0, week 26
Change in mean postprandial increment of plasma glucose after dinner from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner.
week 0, week 26
Change in Mean Postprandial Increment of Plasma Glucose After Breakfast, Weeks 26-78
Time Frame: week 26, week 78
Change in mean postprandial increment of plasma glucose after breakfast from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after breakfast.
week 26, week 78
Change in Mean Postprandial Increment of Plasma Glucose After Lunch, Weeks 26-78
Time Frame: week 26, week 78
Change in mean postprandial increment of plasma glucose after lunch from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after lunch.
week 26, week 78
Change in Mean Postprandial Increment of Plasma Glucose After Dinner, Weeks 26-78
Time Frame: week 26, week 78
Change in mean postprandial increment of plasma glucose after dinner from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner.
week 26, week 78
Change in Mean Postprandial Increment of Plasma Glucose After Breakfast at Week 78
Time Frame: week 0, week 78
Change in mean postprandial increment of plasma glucose after breakfast from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after breakfast.
week 0, week 78
Change in Mean Postprandial Increment of Plasma Glucose After Lunch at Week 78
Time Frame: week 0, week 78
Change in mean postprandial increment of plasma glucose after lunch from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after lunch.
week 0, week 78
Change in Mean Postprandial Increment of Plasma Glucose After Dinner at Week 78
Time Frame: week 0, week 78
Change in mean postprandial increment of plasma glucose after dinner from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner.
week 0, week 78
Change in Beta-cell Function at Week 26
Time Frame: week 0, week 26

Change in Beta-cell function from baseline (week 0) to 26 weeks (end of randomisation). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B).

Beta-cell function: HOMA-B (%) = 20∙fasting insulin[uU/mL] divided by (FPG mmol/L]-3.5).
week 0, week 26
Change in Beta-cell Function, Weeks 26-78
Time Frame: week 26, week 78

Change in Beta-cell function from Week 26 (end of randomisation) to Week 78 (end of treatment). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B).

Beta-cell function: HOMA-B (%) = 20∙fasting insulin[uU/mL] divided by (FPG mmol/L]-3.5).
week 26, week 78
Change in Beta-cell Function at Week 78
Time Frame: week 0, week 78

Change in Beta-cell function from baseline (week 0) to 78 weeks (end of treatment). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B).

Beta-cell function: HOMA-B (%) = 20∙fasting insulin[uU/mL] divided by (FPG mmol/L]-3.5).
week 0, week 78
Change in Total Cholesterol at Week 26
Time Frame: week 0, week 26
Change in total cholesterol (TC) from baseline (week 0) to 26 weeks (end of randomisation)
week 0, week 26
Change in Total Cholesterol, Weeks 26-78
Time Frame: week 26, week 78
Change in total cholesterol (TC) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).
week 26, week 78
Change in Total Cholesterol at Week 78
Time Frame: week 0, week 78
Change in total cholesterol (TC) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).
week 0, week 78
Change in Low-density Lipoprotein-cholesterol at Week 26
Time Frame: week 0, week 26
Change in Low-density Lipoprotein-cholesterol (LDL-C) from baseline (week 0) to 26 weeks (end of randomisation)
week 0, week 26
Change in Low-density Lipoprotein-cholesterol, Weeks 26-78
Time Frame: week 26, week 78
Change in low-density lipoprotein-cholesterol (LDL-C) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).
week 26, week 78
Change in Low-density Lipoprotein-cholesterol at Week 78
Time Frame: week 0, week 78
Change in Low-density Lipoprotein-cholesterol (LDL-C) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).
week 0, week 78
Change in Very Low-density Lipoprotein-cholesterol at Week 26
Time Frame: week 0, week 26
Change in very low-density lipoprotein-cholesterol (VLDL-C) from baseline (week 0) to 26 weeks (end of randomisation)
week 0, week 26
Change in Very Low-density Lipoprotein-cholesterol, Weeks 26-78
Time Frame: week 26, week 78
Change in Very Low-density Lipoprotein-cholesterol (VLDL-C) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).
week 26, week 78
Change in Very Low-density Lipoprotein-cholesterol at Week 78
Time Frame: week 0, week 78
Change in Very Low-density Lipoprotein-cholesterol (VLDL-C) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).
week 0, week 78
Change in High-density Lipoprotein-cholesterol at Week 26
Time Frame: week 0, week 26
Change in High-density Lipoprotein-cholesterol (HDL-C) from baseline (week 0) to 26 weeks (end of randomisation)
week 0, week 26
Change in High-density Lipoprotein-cholesterol, Weeks 26-78
Time Frame: week 26, week 78
Change in High-density Lipoprotein-cholesterol (HDL-C) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).
week 26, week 78
Change in High-density Lipoprotein-cholesterol at Week 78
Time Frame: week 0, week 78
Change in High-density Lipoprotein-cholesterol (HDL-C) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).
week 0, week 78
Change in Triglyceride at Week 26
Time Frame: week 0, week 26
Change in triglyceride (TG) from from baseline (week 0) to 26 weeks (end of randomisation)
week 0, week 26
Change in Triglyceride, Weeks 26-78
Time Frame: week 26, week 78
Change in Triglyceride (TG) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).
week 26, week 78
Change in Triglyceride at Week 78
Time Frame: week 0, week 78
Change in triglyceride (TG) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).
week 0, week 78
Change in Free Fatty Acid at Week 26
Time Frame: week 0, week 26
Change in Free Fatty Acid (FFA) from baseline (week 0) to 26 weeks (end of randomisation)
week 0, week 26
Change in Free Fatty Acid, Weeks 26-78
Time Frame: week 26, week 78
Change in Free Fatty Acid (FFA) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).
week 26, week 78
Change in Free Fatty Acid at Week 78
Time Frame: week 0, week 78
Change in Free Fatty Acid (FFA) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).
week 0, week 78
Change in Apolipoprotein B at Week 26
Time Frame: week 0, week 26
Change in apolipoprotein B (ApoB) from baseline (week 0) to 26 weeks (end of randomisation)
week 0, week 26
Change in Apolipoprotein B, Weeks 26-78
Time Frame: week 26, week 78
Change in apolipoprotein B (ApoB) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).
week 26, week 78
Change in Apolipoprotein B at Week 78
Time Frame: week 0, week 78
Change in apolipoprotein B (ApoB) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).
week 0, week 78
Hypoglycaemic Episodes at Week 26
Time Frame: weeks 0-26
Total number of hypoglycaemic episodes occurring after baseline (week 0) and until week 26 (end of randomisation). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.
weeks 0-26
Hypoglyceamic Episodes, Weeks 26-78
Time Frame: weeks 26-78
Total number of hypoglycaemic episodes occurring after end of randomisation (week 26) and until week 78 (end of treatment). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.
weeks 26-78

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

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.
August 1, 2007

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.
April 1, 2008

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.
April 1, 2009

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).
August 20, 2007

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.
August 20, 2007

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.
August 21, 2007

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 8, 2017

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.
January 25, 2017

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.
January 1, 2017

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.
  • NN2211-1797
  • 2006-006092-21 (EudraCT Number)

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

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Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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