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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00518882
First received: August 20, 2007
Last updated: January 25, 2017
Last verified: January 2017
  Purpose
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.

Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: liraglutide
Drug: exenatide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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).


  • 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).


  • 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).


  • 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)

  • 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).

  • 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).

  • 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)

  • 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).

  • 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).

  • 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)

  • 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).

  • 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).

  • 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)

  • 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).

  • 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).

  • 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)

  • 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).

  • 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).

  • 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)

  • 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).

  • 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).

  • 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)

  • 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).

  • 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).

  • 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.

  • 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.


Enrollment: 467
Study Start Date: August 2007
Study Completion Date: April 2009
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00518882

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Locations
United States, Alabama
Novo Nordisk Investigational Site
Birmingham, Alabama, United States, 35242
United States, Arizona
Novo Nordisk Investigational Site
Goodyear, Arizona, United States, 85395
United States, California
Novo Nordisk Investigational Site
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
United States, Florida
Novo Nordisk Investigational Site
Fort Myers, Florida, United States, 33907
Novo Nordisk Investigational Site
Hollywood, Florida, United States, 33023
Novo Nordisk Investigational Site
Jacksonville, Florida, United States, 32205
Novo Nordisk Investigational Site
Jacksonville, Florida, United States, 32216
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
United States, Georgia
Novo Nordisk Investigational Site
Atlanta, Georgia, United States, 30318
Novo Nordisk Investigational Site
Powder Springs, Georgia, United States, 30127
Novo Nordisk Investigational Site
Roswell, Georgia, United States, 30076
United States, Idaho
Novo Nordisk Investigational Site
Idaho Falls, Idaho, United States, 83404-7596
United States, Illinois
Novo Nordisk Investigational Site
Chicago, Illinois, United States, 60616
Novo Nordisk Investigational Site
Peoria, Illinois, United States, 61615
United States, Indiana
Novo Nordisk Investigational Site
Evansville, Indiana, United States, 47714
United States, Iowa
Novo Nordisk Investigational Site
Des Moines, Iowa, United States, 50314-3027
United States, Louisiana
Novo Nordisk Investigational Site
New Orleans, Louisiana, United States, 70121
United States, Minnesota
Novo Nordisk Investigational Site
Minneapolis, Minnesota, United States, 55416
Novo Nordisk Investigational Site
St. Paul, Minnesota, United States, 55108
United States, Missouri
Novo Nordisk Investigational Site
St. Peters, Missouri, United States, 63376
United States, New Jersey
Novo Nordisk Investigational Site
Flemington, New Jersey, United States, 08822
Novo Nordisk Investigational Site
South Bound Brook, New Jersey, United States, 08880
United States, New York
Novo Nordisk Investigational Site
Northport, New York, United States, 11768
United States, North Carolina
Novo Nordisk Investigational Site
Chapel Hill, North Carolina, United States, 27517
United States, Ohio
Novo Nordisk Investigational Site
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
United States, Oklahoma
Novo Nordisk Investigational Site
Oklahoma City, Oklahoma, United States, 73103
United States, Pennsylvania
Novo Nordisk Investigational Site
Altoona, Pennsylvania, United States, 16602
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, United States, 19152
Novo Nordisk Investigational Site
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
Novo Nordisk Investigational Site
Sumter, South Carolina, United States, 29150
United States, Tennessee
Novo Nordisk Investigational Site
Chattanooga, Tennessee, United States, 37404
United States, Texas
Novo Nordisk Investigational Site
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
United States, Virginia
Novo Nordisk Investigational Site
Newport News, Virginia, United States, 23606
Novo Nordisk Investigational Site
Richmond, Virginia, United States, 23294
United States, Washington
Novo Nordisk Investigational Site
Olympia, Washington, United States, 98502
Novo Nordisk Investigational Site
Spokane, Washington, United States, 99218
United States, Wisconsin
Novo Nordisk Investigational Site
Milwaukee, Wisconsin, United States, 53209
Austria
Novo Nordisk Investigational Site
Graz, Austria, 8036
Novo Nordisk Investigational Site
Wien, Austria, 1030
Novo Nordisk Investigational Site
Wien, Austria, 1130
Denmark
Novo Nordisk Investigational Site
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
Finland
Novo Nordisk Investigational Site
Helsinki, Finland, 00029
Novo Nordisk Investigational Site
Lahti, Finland, 15110
Novo Nordisk Investigational Site
Oulu, Finland, FI-90100
France
Novo Nordisk Investigational Site
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
Narbonne, France, 11108
Novo Nordisk Investigational Site
NEVERS cedex, France, 58033
Germany
Novo Nordisk Investigational Site
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
Ireland
Novo Nordisk Investigational Site
Dublin 24, Ireland
Novo Nordisk Investigational Site
Dublin 9, Ireland
Novo Nordisk Investigational Site
Dublin, Ireland, DUBLIN 7
Novo Nordisk Investigational Site
Dublin, Ireland, DUBLIN 8
Macedonia, The Former Yugoslav Republic of
Novo Nordisk Investigational Site
Skopje, Macedonia, The Former Yugoslav Republic of, 1000
Norway
Novo Nordisk Investigational Site
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
Poland
Novo Nordisk Investigational Site
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
Puerto Rico
Novo Nordisk Investigational Site
Manati, Puerto Rico, 00674
Romania
Novo Nordisk Investigational Site
Alba Iulia, Alba, Romania, 510053
Novo Nordisk Investigational Site
Resita, Romania, 320076
Novo Nordisk Investigational Site
Suceava, Romania, 720237
Slovenia
Novo Nordisk Investigational Site
Koper, Slovenia, SI-6000
Novo Nordisk Investigational Site
Ljubljana, Slovenia, 1525
Novo Nordisk Investigational Site
Novo mesto, Slovenia, 8000
Spain
Novo Nordisk Investigational Site
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
Sweden
Novo Nordisk Investigational Site
Stockholm, Sweden, 141 86
Novo Nordisk Investigational Site
Stockholm, Sweden, 171 76
Switzerland
Novo Nordisk Investigational Site
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
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00518882     History of Changes
Other Study ID Numbers: NN2211-1797
2006-006092-21 ( EudraCT Number )
Study First Received: August 20, 2007
Results First Received: February 23, 2010
Last Updated: January 25, 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Exenatide
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on March 30, 2017