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A Study to Compare the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly to Those of Sitagliptin and Pioglitazone,in Subjects With Type 2 Diabetes Treated With Metformin (DURATION - 2)

NCT00637273 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 514

Last updated 2015-04-07

Study results available
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Summary

This study will compare the benefits of exenatide once weekly treatment to those achieved by the approved antidiabetic therapies sitagliptin and pioglitazone in subjects whose type 2 diabetes is managed with metformin therapy alone. The safety and tolerability of the three treatment regimens will also be compared.

Conditions

Interventions

DRUG

exenatide once weekly

subcutaneous injection, 2.0mg, once a week

DRUG

sitagliptin

oral tablet, 100mg, once a day

DRUG

pioglitazone

oral tablet, 45mg, once a day

DRUG

placebo tablet

oral tablet, once a day

DRUG

placebo once weekly

subcutaneous injection, once a week

Sponsors & Collaborators

Principal Investigators

  • Lisa Porter, MD · Amylin Pharmaceuticals, LLC.

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
2009-02-28
Completion
2009-07-31

Countries

  • United States
  • India
  • Mexico

Study Locations

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Entities

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 NCT00637273 on ClinicalTrials.gov