A Comparison of Adding Exenatide With Switching to Exenatide in Patients With Type 2 Diabetes Experiencing Inadequate Glycemic Control With Sitagliptin Plus Metformin

NCT00870194 · Completed

Last updated 2026-05-28

This clinical trial is testing whether adding exenatide to sitagliptin and metformin or switching to exenatide while stopping sitagliptin helps people with type 2 diabetes better control their blood sugar levels.

Status Completed The study has finished.

Phase Phase 4 Monitors a drug already on the market.

Type Interventional (clinical trial)

Design Randomized, double-blind treatment study

Participants 255 people

Who can join Ages 18–75 · all sexes

Timeline Started 2009-03 · est. completion 2010-04

Where 36 sites · Argentina, Australia, Germany, Greece, India, Mexico, South Korea

What this study is testing ClinicalTrials.gov NCT00870194 ↗

Description as written by the study sponsor.

The purpose of this study is to determine whether ceasing sitagliptin and switching to exenatide and metformin is non-inferior to adding exenatide to sitagliptin and metformin, in those patients with type 2 diabetes who are experiencing inadequate glycemic control with a combination of sitagliptin and metformin.

Treatments tested

exenatide and sitagliptin also known as exenatide-Byetta; sitagliptin-Januvia Drug

exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; sitagliptin-100mg tablet orally once a day
exenatide and placebo also known as exenatide-Byetta Drug

exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; placebo-tablet orally once a day

Main thing measured	Change in HbA1c (Percent)
Sponsor	AstraZeneca
Conditions studied	Type 2 Diabetes Mellitus
GLP-1 drugs	exenatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT00870194 ↗