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A Phase III Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes Who Are Not Well Controlled on Metformin Alone

NCT00528879 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 915

Last updated 2015-10-20

Study results available
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Summary

The purpose of this clinical research study is to learn whether dapagliflozin can help reduce blood sugar levels in participants with Type 2 diabetes that is not well controlled on metformin alone. The safety of this treatment will also be studied.

Conditions

Interventions

DRUG

Dapagliflozin

Tablets administered orally as a 2.5-, 5-, or 10-mg dose once daily for up to 102 weeks

DRUG

Placebo

Dapagliflozin-matching placebo administered as tablets orally once daily for up to 102 weeks

DRUG

Metformin

Open-label metformin administered as ≥1500 mg per day for up to 102 weeks

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
77 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2008-11-30
Completion
2010-05-31

Countries

  • United States
  • Argentina
  • Brazil
  • Canada
  • Mexico

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 NCT00528879 on ClinicalTrials.gov