Effects of Exenatide on Glycemic Control and Weight in Continuous Subcutaneous Insulin Infusion (CSII) Type 2 Treated Patients With Type 2 Diabetes

NCT01140893 · Unknown status

Last updated 2026-05-28

This clinical trial tested whether adding exenatide to insulin therapy in adults with type 2 diabetes who use insulin pumps could help improve blood sugar control over 6 months.

Status Unknown status The sponsor has not confirmed the status recently.

Phase Phase2, Phase3

Type Interventional (clinical trial)

Design Randomized, quadruple-blind treatment study

Participants 110 people Planned (estimated).

Who can join Ages 35–70 · all sexes

Timeline Started 2010-11

Where 3 sites · France

What this study is testing ClinicalTrials.gov NCT01140893 ↗

Description as written by the study sponsor.

The purpose of this study is to determine whether exenatide is effective to improve glycemic control among type 2 diabetic patients treated by insulin pump therapy.

Treatments tested

Exenatide also known as Exenatide = BYETTA (R) Drug

Research drug (exenatide or placebo), will begin at V0, after randomization. The initial dosage for the first month will be 5 µg SC BID. Injections can be administered at any time within the 60 minute period before the morning and evening meal. From V1, research drug will be titrated from 5 to 10 µg SC BID. If gastro-intestinal adverse effects occur with 10 µg SC BID, the dosage will be back-titrated to 5 µg SC BID. Thus, the higher research drug dosage tolerated will be used during the study time.
Placebo Drug

Placebo

Main thing measured	Change from baseline to 6 months of centrally measured HbA1c
Sponsor	University Hospital, Caen
Conditions studied	Type 2 Diabetes
GLP-1 drugs	exenatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT01140893 ↗