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Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using a Thiazolidinedione or a Thiazolidinedione and Metformin

NCT00603239 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 165

Last updated 2015-04-07

Study results available
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Summary

This study will assess safety and efficacy of exenatide in combination with a thiazolidinedione (TZD) and a TZD plus metformin over 26 weeks in adult patients with type 2 diabetes who have not achieved adequate glycemic control.

Conditions

Interventions

DRUG

exenatide

subcutaneous injection, 5 mcg or 10 mcg, twice a day (BID)

DRUG

placebo

subcutaneous injection, volume equivalent to 5 mcg or 10 mcg of active drug, twice a day

Sponsors & Collaborators

Principal Investigators

  • Chief Medical Officer, MD · Eli Lilly and Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2009-07-31
Completion
2009-07-31

Countries

  • United States
  • Canada
  • Mexico
  • Romania
  • South Africa

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00603239 on ClinicalTrials.gov