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:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00518882
First received: August 20, 2007
Last updated: June 19, 2012
Last verified: June 2012
Results First Received: February 23, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Diabetes
Diabetes Mellitus, Type 2
Interventions: Drug: liraglutide
Drug: exenatide

  Participant Flow


  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Liraglutide -> Liraglutide -> Liraglutide Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Exenatide -> Liraglutide -> Liraglutide Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Total Total of all reporting groups

Baseline Measures
    Liraglutide -> Liraglutide -> Liraglutide     Exenatide -> Liraglutide -> Liraglutide     Total  
Number of Participants  
[units: participants]
  233     231     464  
Age  
[units: years]
Mean ± Standard Deviation
  56.3  ± 9.8     57.1  ± 10.8     56.7  ± 10.3  
Gender  
[units: participants]
     
Female     119     104     223  
Male     114     127     241  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     32     25     57  
Not Hispanic or Latino     201     206     407  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     1     1  
Asian     0     4     4  
Native Hawaiian or Other Pacific Islander     1     1     2  
Black or African American     13     12     25  
White     216     210     426  
More than one race     0     0     0  
Unknown or Not Reported     3     3     6  
Previous OAD treatment [1]
[units: participants]
     
Metformin/Sulphonylurea Combination     145     147     292  
Sulphonylurea     24     21     45  
Metformin     64     63     127  
BMI [2]
[units: kg/m2]
Mean ± Standard Deviation
  32.9  ± 5.5     32.9  ± 5.7     32.9  ± 5.6  
Duration of diabetes [3]
[units: years]
Mean ± Standard Deviation
  8.5  ± 6.2     7.9  ± 5.9     8.2  ± 6.0  
HbA1c [4]
[units: percentage of total haemoglobin]
Mean ± Standard Deviation
  8.4  ± 1.0     8.2  ± 1.0     8.3  ± 1.0  
Height  
[units: m]
Mean ± Standard Deviation
  1.68  ± 0.10     1.68  ± 0.10     1.68  ± 0.10  
Weight  
[units: kg]
Mean ± Standard Deviation
  93.1  ± 20.1     93.0  ± 19.5     93.1  ± 19.8  
[1] OAD = Oral Anti-diabetic Drug
[2] Body Mass Index
[3] Number of years since diagnosis
[4] Glycosylated Haemoglobin at screening



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Glycosylated A1c (HbA1c) at Week 26   [ Time Frame: week 0, week 26 ]

2.  Secondary:   Change in Glycosylated A1c (HbA1c), Weeks 26-78   [ Time Frame: week 26, week 78 ]

3.  Secondary:   Change in Glycosylated A1c (HbA1c) at Week 78   [ Time Frame: week 0, week 78 ]

4.  Secondary:   Percentage of Subjects Achieving Treatment Target of Either HbA1c < 7.0% or =< 6.5% at Week 26   [ Time Frame: week 0, week 26 ]

5.  Secondary:   Percentage of Subjects Achieving Treatment Target of Either HbA1c < 7.0% or =< 6.5% at Week 78   [ Time Frame: week 0, week 78 ]

6.  Secondary:   Change in Body Weight at Week 26   [ Time Frame: week 0, week 26 ]

7.  Secondary:   Change in Body Weight, Weeks 26-78   [ Time Frame: week 26, week 78 ]

8.  Secondary:   Change in Body Weight at Week 78   [ Time Frame: week 0, week 78 ]

9.  Secondary:   Change in Fasting Plasma Glucose at Week 26   [ Time Frame: week 0, week 26 ]

10.  Secondary:   Change in Fasting Plasma Glucose, Weeks 26-78   [ Time Frame: week 26, week 78 ]

11.  Secondary:   Change in Fasting Plasma Glucose at Week 78   [ Time Frame: week 0, week 78 ]

12.  Secondary:   Change in Mean Prandial Increment of Plasma Glucose After Breakfast at Week 26   [ Time Frame: week 0, week 26 ]

13.  Secondary:   Change in Mean Prandial Increment of Plasma Glucose After Lunch at Week 26   [ Time Frame: week 0, week 26 ]

14.  Secondary:   Change in Mean Prandial Increment of Plasma Glucose After Dinner at Week 26   [ Time Frame: week 0, week 26 ]

15.  Secondary:   Change in Mean Prandial Increment of Plasma Glucose After Breakfast, Weeks 26-78   [ Time Frame: week 26, week 78 ]

16.  Secondary:   Change in Mean Prandial Increment of Plasma Glucose After Lunch, Weeks 26-78   [ Time Frame: week 26, week 78 ]

17.  Secondary:   Change in Mean Prandial Increment of Plasma Glucose After Dinner, Weeks 26-78   [ Time Frame: week 26, week 78 ]

18.  Secondary:   Change in Mean Prandial Increment of Plasma Glucose After Breakfast at Week 78   [ Time Frame: week 0, week 78 ]

19.  Secondary:   Change in Mean Prandial Increment of Plasma Glucose After Lunch at Week 78   [ Time Frame: week 0, week 78 ]

20.  Secondary:   Change in Mean Prandial Increment of Plasma Glucose After Dinner at Week 78   [ Time Frame: week 0, week 78 ]

21.  Secondary:   Change in Mean Postprandial Increment of Plasma Glucose After Breakfast at Week 26   [ Time Frame: week 0, week 26 ]

22.  Secondary:   Change in Mean Postprandial Increment of Plasma Glucose After Lunch at Week 26   [ Time Frame: week 0. week 26 ]

23.  Secondary:   Change in Mean Postprandial Increment of Plasma Glucose After Dinner at Week 26   [ Time Frame: week 0, week 26 ]

24.  Secondary:   Change in Mean Postprandial Increment of Plasma Glucose After Breakfast, Weeks 26-78   [ Time Frame: week 26, week 78 ]

25.  Secondary:   Change in Mean Postprandial Increment of Plasma Glucose After Lunch, Weeks 26-78   [ Time Frame: week 26, week 78 ]

26.  Secondary:   Change in Mean Postprandial Increment of Plasma Glucose After Dinner, Weeks 26-78   [ Time Frame: week 26, week 78 ]

27.  Secondary:   Change in Mean Postprandial Increment of Plasma Glucose After Breakfast at Week 78   [ Time Frame: week 0, week 78 ]

28.  Secondary:   Change in Mean Postprandial Increment of Plasma Glucose After Lunch at Week 78   [ Time Frame: week 0, week 78 ]

29.  Secondary:   Change in Mean Postprandial Increment of Plasma Glucose After Dinner at Week 78   [ Time Frame: week 0, week 78 ]

30.  Secondary:   Change in Beta-cell Function at Week 26   [ Time Frame: week 0, week 26 ]

31.  Secondary:   Change in Beta-cell Function, Weeks 26-78   [ Time Frame: week 26, week 78 ]

32.  Secondary:   Change in Beta-cell Function at Week 78   [ Time Frame: week 0, week 78 ]

33.  Secondary:   Change in Total Cholesterol at Week 26   [ Time Frame: week 0, week 26 ]

34.  Secondary:   Change in Total Cholesterol, Weeks 26-78   [ Time Frame: week 26, week 78 ]

35.  Secondary:   Change in Total Cholesterol at Week 78   [ Time Frame: week 0, week 78 ]

36.  Secondary:   Change in Low-density Lipoprotein-cholesterol at Week 26   [ Time Frame: week 0, week 26 ]

37.  Secondary:   Change in Low-density Lipoprotein-cholesterol, Weeks 26-78   [ Time Frame: week 26, week 78 ]

38.  Secondary:   Change in Low-density Lipoprotein-cholesterol at Week 78   [ Time Frame: week 0, week 78 ]

39.  Secondary:   Change in Very Low-density Lipoprotein-cholesterol at Week 26   [ Time Frame: week 0, week 26 ]

40.  Secondary:   Change in Very Low-density Lipoprotein-cholesterol, Weeks 26-78   [ Time Frame: week 26, week 78 ]

41.  Secondary:   Change in Very Low-density Lipoprotein-cholesterol at Week 78   [ Time Frame: week 0, week 78 ]

42.  Secondary:   Change in High-density Lipoprotein-cholesterol at Week 26   [ Time Frame: week 0, week 26 ]

43.  Secondary:   Change in High-density Lipoprotein-cholesterol, Weeks 26-78   [ Time Frame: week 26, week 78 ]

44.  Secondary:   Change in High-density Lipoprotein-cholesterol at Week 78   [ Time Frame: week 0, week 78 ]

45.  Secondary:   Change in Triglyceride at Week 26   [ Time Frame: week 0, week 26 ]

46.  Secondary:   Change in Triglyceride, Weeks 26-78   [ Time Frame: week 26, week 78 ]

47.  Secondary:   Change in Triglyceride at Week 78   [ Time Frame: week 0, week 78 ]

48.  Secondary:   Change in Free Fatty Acid at Week 26   [ Time Frame: week 0, week 26 ]

49.  Secondary:   Change in Free Fatty Acid, Weeks 26-78   [ Time Frame: week 26, week 78 ]

50.  Secondary:   Change in Free Fatty Acid at Week 78   [ Time Frame: week 0, week 78 ]

51.  Secondary:   Change in Apolipoprotein B at Week 26   [ Time Frame: week 0, week 26 ]

52.  Secondary:   Change in Apolipoprotein B, Weeks 26-78   [ Time Frame: week 26, week 78 ]

53.  Secondary:   Change in Apolipoprotein B at Week 78   [ Time Frame: week 0, week 78 ]

54.  Secondary:   Hypoglycaemic Episodes at Week 26   [ Time Frame: weeks 0-26 ]

55.  Secondary:   Hypoglyceamic Episodes, Weeks 26-78   [ Time Frame: weeks 26-78 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information