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

• ClinicalTrials.gov Identifier: NCT00518882
• Recruitment Status: Completed
• First Posted: August 21, 2007
• Results First Posted: March 23, 2010
• Last Update Posted: March 8, 2017
• Sponsor: Novo Nordisk A/S
• Information provided by (Responsible Party): Novo Nordisk A/S

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Diabetes; Diabetes Mellitus, Type 2	Drug: liraglutide; Drug: exenatide	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 467 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• 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
• Study Start Date: August 2007
• Actual Primary Completion Date: April 2008
• Actual Study Completion Date: April 2009

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. 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 :

1. 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)
2. 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)
3. 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)
4. 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)
5. 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)
6. 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)
7. 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)
8. 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)
9. 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)
10. 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)
11. 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.
12. 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.
13. 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.
14. 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.
15. 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.
16. 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.
17. 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.
18. 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.
19. 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.
20. 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.
21. 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.
22. 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.
23. 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.
24. 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.
25. 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.
26. 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.
27. 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.
28. 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.
29. 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).

30. 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).

31. 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).

32. 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)
33. 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).
34. 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).
35. 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)
36. 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).
37. 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).
38. 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)
39. 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).
40. 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).
41. 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)
42. 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).
43. 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).
44. 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)
45. 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).
46. 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).
47. 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)
48. 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).
49. 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).
50. 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)
51. 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).
52. 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).
53. 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.
54. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• 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

Locations

United States, Alabama

Novo Nordisk Investigational Site

Birmingham, Alabama, United States, 35242

United States, Arizona

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Goodyear, Arizona, United States, 85395

United States, California

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Artesia, California, United States, 90701

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Encino, California, United States, 91436

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Escondido, California, United States, 92025

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Los Angeles, California, United States, 90057

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Orange, California, United States, 92869

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Sacramento, California, United States, 95816

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San Mateo, California, United States, 94401

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Spring Valley, California, United States, 91978

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Walnut Creek, California, United States, 94598

United States, Florida

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Fort Myers, Florida, United States, 33907

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Hollywood, Florida, United States, 33023

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Jacksonville, Florida, United States, 32205

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Jacksonville, Florida, United States, 32216

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Jacksonville, Florida, United States, 32259

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Longwood, Florida, United States, 32779

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Ocala, Florida, United States, 34471

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Pembroke Pines, Florida, United States, 33029

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Plantation, Florida, United States, 33324

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St. Cloud, Florida, United States, 34769

United States, Georgia

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Atlanta, Georgia, United States, 30318

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Powder Springs, Georgia, United States, 30127

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Roswell, Georgia, United States, 30076

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Idaho Falls, Idaho, United States, 83404-7596

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Chicago, Illinois, United States, 60616

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Peoria, Illinois, United States, 61615

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Evansville, Indiana, United States, 47714

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Des Moines, Iowa, United States, 50314-3027

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New Orleans, Louisiana, United States, 70121

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Minneapolis, Minnesota, United States, 55416

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St. Paul, Minnesota, United States, 55108

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St. Peters, Missouri, United States, 63376

United States, New Jersey

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Flemington, New Jersey, United States, 08822

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South Bound Brook, New Jersey, United States, 08880

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Northport, New York, United States, 11768

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Chapel Hill, North Carolina, United States, 27517

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Canton, Ohio, United States, 44718

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Cincinnati, Ohio, United States, 45206

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Dayton, Ohio, United States, 45439

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Kettering, Ohio, United States, 45429

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Mentor, Ohio, United States, 44060

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Oklahoma City, Oklahoma, United States, 73103

United States, Pennsylvania

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Altoona, Pennsylvania, United States, 16602

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Philadelphia, Pennsylvania, United States, 19152

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Pittsburgh, Pennsylvania, United States, 15213

United States, South Carolina

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Sumter, South Carolina, United States, 29150

United States, Tennessee

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Chattanooga, Tennessee, United States, 37404

United States, Texas

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Austin, Texas, United States, 78731

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Corpus Christi, Texas, United States, 78412

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Dallas, Texas, United States, 75230

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Dallas, Texas, United States, 75231

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Dallas, Texas, United States, 75246

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Houston, Texas, United States, 77030

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Midland, Texas, United States, 79707

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San Antonio, Texas, United States, 78229

United States, Virginia

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Newport News, Virginia, United States, 23606

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Richmond, Virginia, United States, 23294

United States, Washington

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Olympia, Washington, United States, 98502

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Spokane, Washington, United States, 99218

United States, Wisconsin

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Milwaukee, Wisconsin, United States, 53209

Austria

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Graz, Austria, 8036

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Wien, Austria, 1030

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Wien, Austria, 1130

Denmark

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Aalborg, Denmark, 9000

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Gentofte, Denmark, 2820

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Hvidovre, Denmark, 2650

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Odense, Denmark, 5000

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Århus C, Denmark, 8000

Finland

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Helsinki, Finland, 00029

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Lahti, Finland, 15110

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Oulu, Finland, FI-90100

France

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Antibes, France, 06600

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Dommartin Les Toul, France, 54201

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LA ROCHELLE cedex, France, 17019

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Narbonne, France, 11108

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NEVERS cedex, France, 58033

Germany

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Bochum, Germany, 44791

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Dreieich-Sprendlingen, Germany, 63303

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Falkensee, Germany, 14612

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Frankfurt, Germany, 60388

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Hamburg, Germany, 22607

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Hannover, Germany, 30625

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Herrenberg, Germany, 71083

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Lampertheim, Germany, 68623

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Ludwigshafen, Germany, 67059

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Marburg, Germany, 35039

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Pohlheim, Germany, 35415

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Rehlingen-Siersburg, Germany, 66780

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Speyer, Germany, 67346

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Tübingen, Germany, 72072

Ireland

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Dublin 24, Ireland

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Dublin 9, Ireland

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Dublin, Ireland, DUBLIN 7

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Dublin, Ireland, DUBLIN 8

Macedonia, The Former Yugoslav Republic of

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Skopje, Macedonia, The Former Yugoslav Republic of, 1000

Norway

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Bergen, Norway, 5021

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Bergen, Norway, NO-5012

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Stavanger, Norway, 4011

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Trondheim, Norway, NO-7030

Poland

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Bydgoszcz, Poland, 85-822

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Gniewkowo, Poland, 88-140

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Krakow, Poland, 31-501

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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:

Clinical Trials at Novo Nordisk 

Publications of Results:

Sullivan SD, Alfonso-Cristancho R, Conner C, Hammer M, Blonde L. Long-term outcomes in patients with type 2 diabetes receiving glimepiride combined with liraglutide or rosiglitazone. Cardiovasc Diabetol. 2009 Feb 26;8:12. doi: 10.1186/1475-2840-8-12.

McGill JB. Insights from the Liraglutide Clinical Development Program--the Liraglutide Effect and Action in Diabetes (LEAD) studies. Postgrad Med. 2009 May;121(3):16-25. doi: 10.3810/pgm.2009.05.1998.

Buse JB, Rosenstock J, Sesti G, Schmidt WE, Montanya E, Brett JH, Zychma M, Blonde L; LEAD-6 Study Group. Liraglutide once a day versus exenatide twice a day for type 2 diabetes: a 26-week randomised, parallel-group, multinational, open-label trial (LEAD-6). Lancet. 2009 Jul 4;374(9683):39-47. doi: 10.1016/S0140-6736(09)60659-0. Epub 2009 Jun 8.

Buse JB, Sesti G, Schmidt WE, Montanya E, Chang CT, Xu Y, Blonde L, Rosenstock J; Liraglutide Effect Action in Diabetes-6 Study Group. Switching to once-daily liraglutide from twice-daily exenatide further improves glycemic control in patients with type 2 diabetes using oral agents. Diabetes Care. 2010 Jun;33(6):1300-3. doi: 10.2337/dc09-2260. Epub 2010 Mar 23.

Schmidt WE, Christiansen JS, Hammer M, Zychma MJ, Buse JB. Patient-reported outcomes are superior in patients with Type 2 diabetes treated with liraglutide as compared with exenatide, when added to metformin, sulphonylurea or both: results from a randomized, open-label study. Diabet Med. 2011 Jun;28(6):715-23. doi: 10.1111/j.1464-5491.2011.03276.x.

Buse JB, Garber A, Rosenstock J, Schmidt WE, Brett JH, Videbaek N, Holst J, Nauck M. Liraglutide treatment is associated with a low frequency and magnitude of antibody formation with no apparent impact on glycemic response or increased frequency of adverse events: results from the Liraglutide Effect and Action in Diabetes (LEAD) trials. J Clin Endocrinol Metab. 2011 Jun;96(6):1695-702. doi: 10.1210/jc.2010-2822. Epub 2011 Mar 30.

Valentine WJ, Palmer AJ, Lammert M, Langer J, Brandle M. Evaluating the long-term cost-effectiveness of liraglutide versus exenatide BID in patients with type 2 diabetes who fail to improve with oral antidiabetic agents. Clin Ther. 2011 Nov;33(11):1698-712. doi: 10.1016/j.clinthera.2011.09.022. Epub 2011 Oct 21.

Bode BW, Brett J, Falahati A, Pratley RE. Comparison of the efficacy and tolerability profile of liraglutide, a once-daily human GLP-1 analog, in patients with type 2 diabetes >/=65 and <65 years of age: a pooled analysis from phase III studies. Am J Geriatr Pharmacother. 2011 Dec;9(6):423-33. doi: 10.1016/j.amjopharm.2011.09.007. Epub 2011 Nov 4.

Henry RR, Buse JB, Sesti G, Davies MJ, Jensen KH, Brett J, Pratley RE. Efficacy of antihyperglycemic therapies and the influence of baseline hemoglobin A(1C): a meta-analysis of the liraglutide development program. Endocr Pract. 2011 Nov-Dec;17(6):906-13. doi: 10.4158/ep.17.6.906.

Zinman B, Schmidt WE, Moses A, Lund N, Gough S. Achieving a clinically relevant composite outcome of an HbA1c of <7% without weight gain or hypoglycaemia in type 2 diabetes: a meta-analysis of the liraglutide clinical trial programme. Diabetes Obes Metab. 2012 Jan;14(1):77-82. doi: 10.1111/j.1463-1326.2011.01493.x. Epub 2011 Oct 30.

Niswender K, Pi-Sunyer X, Buse J, Jensen KH, Toft AD, Russell-Jones D, Zinman B. Weight change with liraglutide and comparator therapies: an analysis of seven phase 3 trials from the liraglutide diabetes development programme. Diabetes Obes Metab. 2013 Jan;15(1):42-54. doi: 10.1111/j.1463-1326.2012.01673.x. Epub 2012 Sep 9.

Alves C, Batel-Marques F, Macedo AF. A meta-analysis of serious adverse events reported with exenatide and liraglutide: acute pancreatitis and cancer. Diabetes Res Clin Pract. 2012 Nov;98(2):271-84. doi: 10.1016/j.diabres.2012.09.008. Epub 2012 Sep 23.

King AB, Montanya E, Pratley RE, Blonde L, Svendsen CB, Donsmark M, Sesti G. Liraglutide achieves A1C targets more often than sitagliptin or exenatide when added to metformin in patients with type 2 diabetes and a baseline A1C <8.0%. Endocr Pract. 2013 Jan-Feb;19(1):64-72. doi: 10.4158/EP12232.OR.

Jensen TM, Saha K, Steinberg WM. Is there a link between liraglutide and pancreatitis? A post hoc review of pooled and patient-level data from completed liraglutide type 2 diabetes clinical trials. Diabetes Care. 2015 Jun;38(6):1058-66. doi: 10.2337/dc13-1210. Epub 2014 Dec 12. Erratum In: Diabetes Care. 2015 Aug;38(8):1622.

Davidson JA, Orsted DD, Campos C. Efficacy and safety of liraglutide, a once-daily human glucagon-like peptide-1 analogue, in Latino/Hispanic patients with type 2 diabetes: post hoc analysis of data from four phase III trials. Diabetes Obes Metab. 2016 Jul;18(7):725-8. doi: 10.1111/dom.12653. Epub 2016 Apr 28.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Fonseca VA, Devries JH, Henry RR, Donsmark M, Thomsen HF, Plutzky J. Reductions in systolic blood pressure with liraglutide in patients with type 2 diabetes: insights from a patient-level pooled analysis of six randomized clinical trials. J Diabetes Complications. 2014 May-Jun;28(3):399-405. doi: 10.1016/j.jdiacomp.2014.01.009. Epub 2014 Jan 21.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT00518882
• Other Study ID Numbers: NN2211-1797; 2006-006092-21 ( EudraCT Number )
• First Posted: August 21, 2007
• Results First Posted: March 23, 2010
• Last Update Posted: March 8, 2017
• Last Verified: January 2017

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Liraglutide; Exenatide; Hypoglycemic Agents; Physiological Effects of Drugs; Incretins; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Obesity Agents