Adjunctive Therapy of Exenatide or Sitagliptin to Insulin Glargine in Type 2 Diabetes
NCT00971659 · Completed
Last updated 2026-05-28This clinical trial tested whether adding exenatide or sitagliptin to insulin glargine helps control blood sugar levels after meals in adults with type 2 diabetes.
What this study is testing ClinicalTrials.gov NCT00971659 ↗
Description as written by the study sponsor.
This study investigated a 4-week adjunctive therapy of either a GLP-1 analog (exenatide), or a DPP-4 inhibitor (sitagliptin), given to a basal insulin analog (insulin glargine), and their effect on blood glucose control, versus insulin glargine alone as active comparator in type 2 diabetes.
Treatments tested
- insulin glargine + exenatide + preexisting metformin also known as Lantus, Byetta Drug
insulin glargine once daily subcutaneously over 4 weeks, dose adjustment according to a treat-to-target algorithm, exenatide 5ug twice daily subcutaneously for 2 weeks, then 10ug twice daily for 2 weeks, continuation of preexisting metformin
- insulin glargine + sitagliptin + preexisting metformin also known as Lantus, Januvia Drug
insulin glargine once daily subcutaneously over 4 weeks, dose adjustment according to a treat-to-target algorithm, sitagliptin 100 mg once daily in the morning over 4 weeks, continuation of preexisting metformin
- insulin glargine + preexisting metformin also known as Lantus Drug
insulin glargine once daily subcutaneously over 4 weeks, continuation of preexisting metformin
| Main thing measured | the unadjusted 6-hour postprandial blood glucose excursion (AUCBG0-6h) following ingestion of a standardized breakfast |
|---|---|
| Sponsor | Profil Institut für Stoffwechselforschung GmbH |
| Conditions studied | Type 2 Diabetes |
| GLP-1 drugs | exenatide |
Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT00971659 ↗