Phase 3
Completed N=69
Effects of Exenatide and Insulin Glargine in Subjects With Type 2 Diabetes
Source: ClinicalTrials.gov NCT00097500 ↗Enrolled (actual)
69
Serious AEs
5.8%
Results posted
Jan 2011
Primary outcomePrimary: Beta-cell Function After 52 Weeks of Therapy — 2.89; 1.15 ratio — p=0.0001
Summary
This Phase 3, open-label, multicenter study is designed to compare the effects of exenatide and insulin glargine (Lantus® injection) on beta-cell function in patients with type 2 diabetes mellitus using metformin.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Beta-cell Function After 52 Weeks of Therapy |
2.89; 1.15 | 0.0001 sig |
| SECONDARY Beta-cell Function 4 Weeks After Cessation of Therapy |
1.02; 1.08 | 0.4185 |
| SECONDARY Change in First Phase C-peptide Release |
1.72; 1.13; 0.95; 1.06 | <0.0001 sig |
| SECONDARY Change in Second Phase C-peptide Release |
2.88; 1.01; 1.00; 1.08 | <0.0001 sig |
| SECONDARY Change in Glycosylated Hemoglobin (HbA1c) |
-0.97; -0.87 | 0.5522 |
| SECONDARY Change in Fasting Plasma Glucose |
-1.53; -3.10 | <0.0001 sig |
| SECONDARY Seven Point Self Monitored Blood Glucose (SMBG) Measurements |
8.92; 8.38; 7.27; 5.63; 11.00; 11.17 | — |
| SECONDARY Change in Body Weight |
-3.80; 0.75 | <0.0001 sig |
| SECONDARY M-value at Baseline, Week 52 and Week 56 |
2.24; 2.79; 3.18; 3.85; 3.19; 2.81 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of type 2 diabetes, but otherwise healthy
- HbA1c between 6.6% and 9.5%, inclusive.
- Body mass index (BMI) of 25 kg/m2 to 40 kg/m2, inclusive.
- Treated with a stable dose of metformin for at least 2 months prior to screening.
Exclusion Criteria
- Patients previously in a study using exenatide.
- Treated with oral anti-diabetic medications other than metformin within 2 months of screening (thiazolidinediones within 5 months of screening).
- Treated with insulin within 3 months of screening.
Data sourced from ClinicalTrials.gov (NCT00097500). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.