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Safety and Efficacy of Exenatide Once Weekly Injection Versus Metformin, Dipeptidyl Peptidase-4 Inhibitor, or Thiazolidinedione as Monotherapy in Drug-Naive Patients With Type 2 Diabetes (DURATION-4)

NCT00676338 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 820

Last updated 2015-04-09

Study results available
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Summary

This study will compare the effects of 2.0 mg exenatide once weekly injection as monotherapy to 3 active comparators(metformin, dipeptidyl peptidase-4 inhibitor, and thiazolidinedione) in drug naive patients with type 2 diabetes treated with diet and exercise.

Conditions

Interventions

DRUG

exenatide once weekly

subcutaneous injection, 2mg, once weekly plus placebo oral once daily

DRUG

metformin

oral, 1000-2500mg, daily plus placebo once weekly subcutaneous injection

DRUG

sitagliptin

oral, 100 mg, daily plus placebo once weekly subcutaneous injection

DRUG

pioglitazone

oral, 30-45mg, daily plus placebo once weekly subcutaneous injection

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
2008-11-30
Primary Completion
2010-07-31
Completion
2011-01-31

Countries

  • United States
  • Argentina
  • Belgium
  • Brazil
  • Canada
  • France
  • Germany
  • Hungary
  • India
  • Israel
  • Italy
  • Mexico
  • Poland
  • Puerto Rico
  • Romania
  • Russia
  • Slovakia
  • South Africa
  • South Korea
  • Spain
  • Turkey (Türkiye)
  • United Kingdom

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 NCT00676338 on ClinicalTrials.gov