Effect of Exenatide Plus Metformin vs. Insulin Aspart Plus Metformin on Glycemic Control and Hypoglycemia 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:
NCT00434954
First received: February 12, 2007
Last updated: September 16, 2013
Last verified: September 2013
Results First Received: June 25, 2010  
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 twice daily (BID)
Drug: premixed insulin aspart twice daily (BID)

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients treated with metformin (MET only;confirmatory population used for primary analysis) and additional patients treated with metformin plus either sulfonylurea or meglitinide (MET+SU; exploratory population) were enrolled at a 3:1 ratio; metformin was continued.Within each population, patients were then randomly assigned 1:1 to study treatment

Reporting Groups
  Description
Exenatide Twice Daily Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
Premixed Insulin Aspart Twice Daily Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks

Participant Flow:   Overall Study
    Exenatide Twice Daily     Premixed Insulin Aspart Twice Daily  
STARTED     248     246  
Started - Previous Treatment MET Only     182     181  
Started - Previous Treatment MET + SU     66     65  
Full Analysis Set (FAS) Overall     247 [1]   233 [1]
FAS - Previous Treatment MET Only     181 [2]   173 [2]
FAS - Previous Treatment MET + SU     66     60  
Completed - Previous Treatment MET Only     135     137  
Completed - Previous Treatment MET + SU     31     38  
COMPLETED     166     175  
NOT COMPLETED     82     71  
Adverse Event                 17                 2  
Entry criteria not met                 14                 16  
Lost to Follow-up                 0                 1  
Physician Decision                 6                 3  
Protocol Violation                 36                 27  
Sponsor decision                 1                 0  
Subject decision                 8                 22  
[1] FAS=received >=1 dose of study drug. Adverse event data reported for Overall FAS.
[2] Baseline and efficacy data reported for "FAS-Previous Treatment MET Only" group.



  Baseline Characteristics
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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 Twice Daily Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
Premixed Insulin Aspart Twice Daily Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
Total Total of all reporting groups

Baseline Measures
    Exenatide Twice Daily     Premixed Insulin Aspart Twice Daily     Total  
Number of Participants  
[units: participants]
  181     173     354  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     138     133     271  
>=65 years     43     40     83  
Age  
[units: years]
Mean ± Standard Deviation
  57.2  ± 10.03     56.9  ± 9.94     57.1  ± 9.97  
Gender  
[units: participants]
     
Female     73     77     150  
Male     108     96     204  
Body Mass Index (BMI)  
[units: kg / m^2]
Mean ± Standard Deviation
  33.4  ± 4.23     32.9  ± 4.37     33.2  ± 4.30  
Body Weight  
[units: kg]
Mean ± Standard Deviation
  99.4  ± 16.22     96.6  ± 17.40     98.0  ± 16.85  
Duration of Diabetes  
[units: years]
Mean ± Standard Deviation
  4.8  ± 4.39     5.2  ± 4.67     5.0  ± 4.53  
Glycosylated hemoglobin (HbA1c)  
[units: percentage]
Mean ± Standard Deviation
  7.89  ± 0.822     7.88  ± 0.918     7.88  ± 0.869  



  Outcome Measures
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1.  Primary:   Change in Glycosylated Hemoglobin (HbA1c)   [ Time Frame: Baseline and 26 weeks ]

2.  Primary:   Incidence of Hypoglycemia (Percentage of Participants With at Least One Hypoglycemic Episode)   [ Time Frame: 26 weeks ]

3.  Secondary:   Percentage of Subjects Achieving HbA1c Target of < 6.5%   [ Time Frame: 26 weeks ]

4.  Secondary:   Percentage of Subjects Achieving HbA1c Target of < 7.0%   [ Time Frame: 26 weeks ]

5.  Secondary:   Incidence of Hypoglycemic Episodes [Blood Glucose <= 3.0 mmol/L or Severe] (Percentage of Subjects Who Experienced at Least One Treatment-emergent Hypoglycemic Episode During the 26-week Treatment Period)   [ Time Frame: 26 weeks ]

6.  Secondary:   Incidence of Nocturnal Hypoglycemia (Percentage of Subjects Who Experienced at Least One Episode of Nocturnal Hypoglycemia During the 26 Week Treatment Period)   [ Time Frame: 26 weeks ]

7.  Secondary:   7 Point Self-monitored Blood Glucose (SMBG) Profiles   [ Time Frame: Baseline and 26 weeks ]

8.  Secondary:   Blood Lipid Levels   [ Time Frame: Baseline and 26 weeks ]

9.  Secondary:   Change in Body Weight   [ Time Frame: Baseline and 26 weeks ]

10.  Secondary:   Change in Body Mass Index (BMI)   [ Time Frame: Baseline and 26 weeks ]

11.  Secondary:   Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaire (DTSQ)   [ Time Frame: Baseline and 26 weeks ]

12.  Secondary:   Patient Reported Outcomes: Quality of Life (SF-12)   [ Time Frame: Baseline and 26 weeks ]


  Serious Adverse Events


  Other Adverse Events


  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 Other disclosure agreement that restricts the right of the PI 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
e-mail: clinicaltrials@amylin.com


No publications provided by Bristol-Myers Squibb

Publications automatically indexed to this study:

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00434954     History of Changes
Other Study ID Numbers: H8O-SB-GWBN
Study First Received: February 12, 2007
Results First Received: June 25, 2010
Last Updated: September 16, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices