Efficacy of Once-Weekly Exenatide Versus Once or Twice Daily Insulin Detemir in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01003184
First received: October 15, 2009
Last updated: September 18, 2013
Last verified: September 2013
Results First Received: November 20, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Type 2 Diabetes Mellitus
Interventions: Drug: exenatide once weekly
Drug: insulin detemir

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
6 patients who were enrolled and randomized, subsequently discontinued the study before receiving study drug. These patients were not included in analysis.

Reporting Groups
  Description
Exenatide Once Weekly Exenatide once weekly : subcutaneous injection, 2mg, once a week
Insulin Detemir Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day

Participant Flow:   Overall Study
    Exenatide Once Weekly     Insulin Detemir  
STARTED     111     111  
Full Analysis Set (FAS)     111     105  
COMPLETED     92     99  
NOT COMPLETED     19     12  
Adverse Event                 12                 5  
Lost to Follow-up                 1                 0  
Loss of glucose control                 1                 1  
Protocol Violation                 3                 0  
Withdrawal by Subject                 1                 6  
Physician Decision                 1                 0  



  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
Exenatide Once Weekly Exenatide once weekly : subcutaneous injection, 2mg, once a week
Insulin Detemir Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day
Total Total of all reporting groups

Baseline Measures
    Exenatide Once Weekly     Insulin Detemir     Total  
Number of Participants  
[units: participants]
  111     105     216  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     74     78     152  
>=65 years     37     27     64  
Age  
[units: years]
Mean ± Standard Deviation
  59.2  ± 9.86     57.8  ± 9.48     58.5  ± 9.68  
Gender  
[units: participants]
     
Female     40     33     73  
Male     71     72     143  
HbA1c [1]
[units: Percentage of total hemoglobin]
Mean ± Standard Deviation
  8.4  ± 0.85     8.4  ± 0.88     8.4  ± 0.86  
Weight  
[units: Kilograms]
Mean ± Standard Deviation
  96.7  ± 17.03     97.9  ± 15.82     97.3  ± 16.42  
[1] At visit 3 (week 0).



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Patients Achieving Glycosylated Hemoglobin (HbA1c) Concentration ≤7.0% With Weight Loss (≥1.0 kg) at Endpoint (Week 26)   [ Time Frame: Baseline, Week 26 ]

2.  Secondary:   Percentage of Patients Who Have Achieved HbA1c ≤7.4% With Weight Loss (≥1.0 kg) at Endpoint (Week 26)   [ Time Frame: Baseline, Week 26 ]

3.  Secondary:   Change in HbA1c From Baseline to Week 26   [ Time Frame: Baseline, Week 26 ]

4.  Secondary:   Change in Body Weight From Baseline to Week 26   [ Time Frame: Baseline, Week 26 ]
  Hide Outcome Measure 4

Measure Type Secondary
Measure Title Change in Body Weight From Baseline to Week 26
Measure Description Change in body weight from baseline to week 26
Time Frame Baseline, Week 26  
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.
The analysis was done for the FAS population (as randomised).

Reporting Groups
  Description
Exenatide Once Weekly Exenatide once weekly : subcutaneous injection, 2mg, once a week
Insulin Detemir Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day

Measured Values
    Exenatide Once Weekly     Insulin Detemir  
Number of Participants Analyzed  
[units: participants]
  96     98  
Change in Body Weight From Baseline to Week 26  
[units: kilograms]
Least Squares Mean ± Standard Error
  -2.79  ± 0.347     0.88  ± 0.351  


Statistical Analysis 1 for Change in Body Weight From Baseline to Week 26
Groups [1] All groups
Method [2] Mixed Models Analysis
P Value [3] <.0001
Least Squares Mean Difference [4] -3.67
Standard Error of the mean ± 0.488
95% Confidence Interval ( -4.63 to -2.71 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Mixed model repeated measures MMRM) includes baseline value as covariate, study treatment, use of SU (yes/no), baseline HbA1c stratum, week of visit and treatment-by-week interaction as fixed effects and patient and error as random effects.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



5.  Secondary:   Percentage of Patients Achieving HbA1c ≤7.4% at Endpoint   [ Time Frame: Week 26 ]

6.  Secondary:   Percentage of Patients Achieving ≤7.0% at Endpoint   [ Time Frame: Week 26 ]

7.  Secondary:   Percentage of Patients Achieving ≤6.5% at Endpoint   [ Time Frame: Week 26 ]

8.  Secondary:   Change in Fasting Serum Glucose From Baseline to Endpoint (Week 26).   [ Time Frame: Baseline, Week 26 ]

9.  Secondary:   Changes in Systolic Blood Pressure From Baseline to Week 26   [ Time Frame: Baseline, Week 26 ]

10.  Secondary:   Change in Diastolic Blood Pressure From Baseline to Week 26.   [ Time Frame: Baseline, Week 26 ]

11.  Secondary:   Change in Total Cholesterol From Baseline to Endpoint (Week 26).   [ Time Frame: Baseline, Week 26 ]

12.  Secondary:   Change in High-density Lipoprotein (HDL) Cholesterol From Baseline to Endpoint (Week 26).   [ Time Frame: Baseline, Week 26 ]

13.  Secondary:   Change in Triglycerides From Baseline to Endpoint (Week 26).   [ Time Frame: Baseline, Week 26 ]

14.  Secondary:   Hypoglycemia Rate Per Year   [ Time Frame: Baseline, Week 26 ]


  Serious Adverse Events


  Other Adverse Events


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


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: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 1-877-285-4559
e-mail: clinicaltrials@amylin.com


No publications provided


Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01003184     History of Changes
Other Study ID Numbers: H8O-EW-GWDL
Study First Received: October 15, 2009
Results First Received: November 20, 2012
Last Updated: September 18, 2013
Health Authority: Ireland: Irish Medicines Board
United Kingdom: Medicines and Healthcare Products Regulatory Agency