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Study of Dapagliflozin in Combination With Metformin XR to Initiate the Treatment of Type 2 Diabetes

NCT00859898 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1093

Last updated 2016-07-07

Study results available
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Summary

The primary purpose of this study is to compare the change from baseline in hemoglobin A1C achieved with dapagliflozin 10 mg in combination with metformin XR as compared with metformin XR monotherapy and compared with Dapagliflozin monotherapy, after 24 weeks of oral administration of double-blind treatment. The safety of treatment with dapagliflozin will also be assessed in this study

Conditions

Interventions

DRUG

Dapagliflozin

Tablets, Oral, 10 mg, once daily, 24 weeks

DRUG

Metformin XR

Tablets, Oral, up to 2000 mg, once daily, 24 weeks

DRUG

Metformin XR

Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks

DRUG

dapagliflozin matching Placebo

Tablets

DRUG

metformin HCl Modified Release matching Placebo

Tablets

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2010-05-31
Completion
2010-05-31

Countries

  • United States
  • India
  • Mexico
  • Puerto Rico
  • Russia
  • South Korea

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 NCT00859898 on ClinicalTrials.gov