A Phase III, randomized, open-label, comparator-controlled, parallel-group, multicenter study to compare the effects of exenatide and insulin glargine on beta-cell function and cardiovascular risk markers in subjects with type 2 diabetes treated with metformin who have not achieved target HbA1c
Phase 3
Completed
- Conditions
- Diabetes Mellitus type II (DM type II)Nutritional, Metabolic, EndocrineDiabetes
- Registration Number
- ISRCTN87762302
- Lead Sponsor
- Eli-Lilly (The Netherlands)
- Brief Summary
2009 results in: https://www.ncbi.nlm.nih.gov/pubmed/19196887 (added 21/02/2019)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 75
Inclusion Criteria
1. Patients with type 2 diabetes mellitus (m/f)
2. 30-70 years of age
3. Body mass index 25-40 kg/m2
4. Using stable (>2 months) oral anti-diabetic therapy with metformin alone
5. Subjects must have HbA1c between 6.6% and 9.5%, inclusive.
Exclusion Criteria
1. Use of oral anti-diabetic therapy other than metformin
2. Clinical significant history or presence of hepatic, renal, central nervous system, gastrointestinal, haematological and pulmonary disease
3. Blood pressure >165/95
4. Electrocardiogram with clinically significant abnormalities as judged by the investigator
5. The use of prohibited medication as specified in the protocol
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Glycaemic control and beta-cell function, measured at baseline and after 52 weeks of exenatide or insulin glargine administration.
- Secondary Outcome Measures
Name Time Method <br> 1. Postprandial blood glucose, lipids, lipoproteins and markers of inflammation, coagulation, endothelial function<br> 2. Proportion of subjects with baseline HbA1c >7.0% that achieve HbA1c £7.0%. Proportion of subjects with baseline HbA1c >6.5% that achieve HbA1c £6.5%.<br> 3. Seven-point self-monitored blood glucose profiles.<br>