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Add-on to Thiazolidinedione (TZD) Failures

NCT00683878 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 972

Last updated 2017-02-23

Study results available
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Summary

The purpose of this clinical research study is to learn if BMS-512148 (Dapagliflozin) can help reduce the blood sugar levels in subjects with Type 2 Diabetes who are not well controlled on TZD alone. The safety of this treatment will also be studied

Conditions

Interventions

DRUG

Dapagliflozin

Tablets, Oral, 5.0 mg, once daily, up to 48 weeks

DRUG

Dapagliflozin

Tablets, Oral, 10.0 mg, once daily, up to 48 weeks

DRUG

Placebo matching Dapagliflozin

Tablets, Oral, 0 mg, once daily, up to 48 weeks

DRUG

Thiazolidinedione (Pioglitazone)

Tablets, ≥ 30 mg, Once daily, up to 48 weeks

Sponsors & Collaborators

  • Astra Zeneca, Bristol-Myers Squibb

    collaborator OTHER

  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2010-01-31
Completion
2010-06-30

Countries

  • United States
  • Argentina
  • Canada
  • India
  • Mexico
  • Peru
  • Philippines
  • Puerto Rico
  • Taiwan

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 NCT00683878 on ClinicalTrials.gov