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Completed

NCT Number: NCT00518882

Effect of Liraglutide or Exenatide Added to an Ongoing Treatment on Blood Glucose 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.

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novo Nordisk Investigational Site, Graz, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

liraglutide

Drug

1.8 mg once daily for s.c. (under the skin) injection.

exenatide

Drug

10 mcg twice daily for s.c. (under the skin) injection.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Acronym: LEAD-6

Important dates

Study start
2007
Primary completion
2008
Study completion
2009
First posted
Aug 21, 2007
Registry last updated
Mar 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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