Efficacy and Safety of Pioglitazone and Metformin Combination Therapy in Treating Type 2 Diabetes Mellitus.

NCT00727857 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2011-07-29

Study results available
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Summary

The purpose of this study is to determine the efficacy of pioglitazone, twice daily (BID), combined with metformin versus pioglitazone taken alone and metformin taken alone in treating Type 2 Diabetes Mellitus.

Conditions

Interventions

DRUG

Pioglitazone and metformin

Pioglitazone 15 mg /metformin 850 mg combination, tablets, orally, twice daily for up to 24 weeks.

DRUG

Pioglitazone

Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks.

DRUG

Metformin

Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.

Sponsors & Collaborators

Principal Investigators

  • VP Clinical Science Strategy · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2008-08-31
Completion
2008-08-31

Countries

  • United States
  • Chile
  • Mexico
  • Puerto Rico

Study Locations

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Entities

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 NCT00727857 on ClinicalTrials.gov