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Effect of Liraglutide in Combination With Sulfonylurea (SU) on Blood Glucose Control in Subjects With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00395746
First received: November 2, 2006
Last updated: June 19, 2012
Last verified: June 2012
History of Changes
Results First Received: February 23, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Diabetes
Diabetes Mellitus, Type 2
Interventions: Drug: sulfonylurea
Drug: liraglutide

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
49 sites in Japan

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects included were patients with type 2 diabetes treated with diet therapy and one sulphonylurea (SU) agent (glibenclamide, gliclazide or glimepiride). Subjects continued their current SU therapy with, as a rule, no change in the dose and dosage in the study. A total of 267 subjects were randomised, 3 subjects were not exposed to study drug.

Reporting Groups
  Description
0.6 mg + SU Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
0.9 mg + SU Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
SU Mono Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment

Participant Flow:   Overall Study
    0.6 mg + SU     0.9 mg + SU     SU Mono  
STARTED     88 [1]   88 [1]   88 [1]
COMPLETED     78 [2]   84 [2]   66 [2]
NOT COMPLETED     10     4     22  
Adverse Event                 5                 2                 2  
Protocol Violation                 0                 1                 0  
Lack of Efficacy                 2                 0                 17  
Hypoglycaemia                 2                 1                 0  
Subject decision                 0                 0                 1  
Withdrawal of consent                 0                 0                 1  
Difficultulty in use of device                 0                 0                 1  
Unable to visit site on schedule                 1                 0                 0  
[1] Exposed to study drug
[2] Completed 52 weeks treatment



  Baseline Characteristics
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Reporting Groups
  Description
0.6 mg + SU Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
0.9 mg + SU Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
SU Mono Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
Total Total of all reporting groups

Baseline Measures
    0.6 mg + SU     0.9 mg + SU     SU Mono     Total  
Number of Participants  
[units: participants]
 		  88     88     88     264  
Age, Customized  
[units: participants]
 		       
20-29     0     1     0     1  
30-39     2     4     0     6  
40-49     16     5     19     40  
50-59     24     27     28     79  
60-69     30     32     30     92  
70-     16     19     11     46  
Age  
[units: years]
Mean ± Standard Deviation 		  59.1  ± 10.3     61.3  ± 11.0     58.6  ± 9.7     59.7  ± 10.4  
Gender  
[units: participants]
 		       
Female     35     29     31     95  
Male     53     59     57     169  
BMI [1]
[units: kg/m2]
Mean ± Standard Deviation 		  25.25  ± 3.58     24.40  ± 3.37     24.94  ± 3.96     24.86  ± 3.65  
Body weight  
[units: kg]
Mean ± Standard Deviation 		  66.19  ± 12.03     64.53  ± 11.95     66.79  ± 13.66     65.84  ± 12.56  
Duration of diabetes [2]
[units: years]
Mean ± Standard Deviation 		  9.33  ± 5.77     11.61  ± 7.68     10.06  ± 7.28     10.33  ± 7.00  
HbA1c [3]
[units: percentage of total haemoglobin]
Mean ± Standard Deviation 		  8.48  ± 0.73     8.26  ± 0.71     8.44  ± 0.83     8.39  ± 0.76  
[1] Body Mass Index
[2] Number of years since diagnosis of diabetes
[3] Glycosylated Haemoglobin



  Outcome Measures
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1.  Primary:   Glycosylated Haemoglobin A1c (HbA1c) After 24 Weeks of Treatment   [ Time Frame: after 24 weeks of treatment ]
  Show Outcome Measure 1

2.  Secondary:   Glycosylated Haemoglobin A1c (HbA1c) After 52 Weeks of Treatment   [ Time Frame: after 52 weeks of treatment ]
  Hide Outcome Measure 2

Measure Type Secondary
Measure Title Glycosylated Haemoglobin A1c (HbA1c) After 52 Weeks of Treatment
Measure Description No text entered.
Time Frame after 52 weeks of treatment  
Safety Issue No  

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.
Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.

Reporting Groups
  Description
0.6 mg + SU Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
0.9 mg + SU Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
SU Mono Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment

Measured Values
    0.6 mg + SU     0.9 mg + SU     SU Mono  
Number of Participants Analyzed  
[units: participants]
 		  86     87     88  
Glycosylated Haemoglobin A1c (HbA1c) After 52 Weeks of Treatment  
[units: percentage of total haemoglobin]
Least Squares Mean ± Standard Error 		  7.42  ± 0.12     7.06  ± 0.13     8.39  ± 0.12  


Statistical Analysis 1 for Glycosylated Haemoglobin A1c (HbA1c) After 52 Weeks of Treatment
Groups [1] 0.9 mg + SU vs. SU Mono
Least Squares Mean [2] -1.33
95% Confidence Interval ( -1.62 to -1.04 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  95% confidence interval for the mean difference (each liraglutide – SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.
[2] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Glycosylated Haemoglobin A1c (HbA1c) After 52 Weeks of Treatment
Groups [1] 0.6 mg + SU vs. SU Mono
Least Squares Mean [2] -0.96
95% Confidence Interval ( -1.25 to -0.67 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  95% confidence interval for the mean difference (each liraglutide – SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.
[2] Other relevant estimation information:
  No text entered.



3.  Secondary:   Fasting Plasma Glucose After 24 Weeks of Treatment   [ Time Frame: after 24 weeks of treatment ]
  Show Outcome Measure 3

4.  Secondary:   Fasting Plasma Glucose After 52 Weeks of Treatment   [ Time Frame: after 52 weeks of treatment ]
  Show Outcome Measure 4

5.  Secondary:   Postprandial Glucose AUC After 24 Weeks of Treatment   [ Time Frame: after 24 weeks of treatment ]
  Show Outcome Measure 5

6.  Secondary:   Postprandial Glucose AUC After 52 Weeks of Treatment   [ Time Frame: after 52 weeks of treatment ]
  Show Outcome Measure 6

7.  Secondary:   Mean PG in 7-point Plasma Glucose Profile After 24 Weeks of Treatment   [ Time Frame: after 24 weeks of treatment ]
  Show Outcome Measure 7

8.  Secondary:   Mean PG in 7-point Plasma Glucose Profile After 52 Weeks of Treatment   [ Time Frame: after 52 weeks of treatment ]
  Show Outcome Measure 8

9.  Secondary:   Mean Postprandial PG Increment in 7-point Plasma Glucose Profile After 24 Weeks of Treatment   [ Time Frame: after 24 weeks of treatment ]
  Show Outcome Measure 9

10.  Secondary:   Mean Postprandial PG Increment in 7-point Plasma Glucose Profile After 52 Weeks of Treatment   [ Time Frame: after 52 weeks of treatment ]
  Show Outcome Measure 10

11.  Secondary:   Body Weight After 24 Weeks of Treatment   [ Time Frame: after 24 weeks of treatment ]
  Show Outcome Measure 11

12.  Secondary:   Body Weight After 52 Weeks of Treatment   [ Time Frame: after 52 weeks of treatment ]
  Show Outcome Measure 12

13.  Secondary:   Hypoglycaemic Episodes   [ Time Frame: over 52 weeks of treatment ]
  Show Outcome Measure 13


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


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.  


Results Point of Contact:  
Name/Title: Public Access to Clinical Trials
Organization: Novo Nordisk A/S
e-mail: clinicaltrials@novonordisk.com


No publications provided by Novo Nordisk

Publications automatically indexed to this study:


Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00395746     History of Changes
Other Study ID Numbers: NN2211-1701, JapicCTI-060324
Study First Received: November 2, 2006
Results First Received: February 23, 2010
Last Updated: June 19, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare