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A Phase III Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes Who Are Not Well Controlled With Diet and Exercise

NCT00528372 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1067

Last updated 2015-10-20

Study results available
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Summary

The purpose of this clinical research study is to determine whether dapagliflozin can improve (decrease) blood glucose values in patients with Type 2 diabetes who have never been treated with medication or have been taking medication for less than 24 weeks since their original diabetes diagnosis. The safety of this treatment will also be studied.

Conditions

Interventions

DRUG

Dapagliflozin

Tablets; oral; 2.5, 5.0, or 10 mg; once daily in the morning or evening for up to 102 weeks

DRUG

Dapagliflozin placebo

Tablets, oral, 0 mg, once daily in the morning or evening for up to 102 weeks

DRUG

Metformin

Sponsors & Collaborators

Principal Investigators

  • Anna Maria Langkilde · AstraZeneca

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
2009-02-28
Completion
2010-07-31

Countries

  • United States
  • Canada
  • Mexico
  • Russia

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 NCT00528372 on ClinicalTrials.gov