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Safety and Efficacy of Dapagliflozin in Triple Therapy to Treat Subjects With Type 2 Diabetes

NCT01646320 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2016-06-22

Study results available
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Summary

The purpose of this study is to learn if BMS-512148 (Dapagliflozin) as part of a triple combination therapy can improve (decrease) hemoglobin A1c in patients with type 2 diabetes after 24 weeks of treatment compared to a 2 drug oral antidiabetic therapy. The safety of this treatment will also be studied.

Conditions

Interventions

DRUG

Dapagliflozin

Tablets, Oral, 10 mg, Once daily, Up to 52 weeks

DRUG

Placebo matching with Dapagliflozin

Tablets, Oral, 0 mg, Once daily, Up to 52 weeks

DRUG

Saxagliptin

Tablets, Oral, 5 mg, Once daily, Up to 52 weeks

DRUG

Metformin immediate release (IR)

Tablets, Oral, ≥ 1500 mg, Twice daily, Up to 52 weeks

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2014-08-31
Completion
2015-02-28

Countries

  • United States
  • Czechia
  • Mexico
  • Poland
  • Puerto Rico
  • Romania
  • Russia
  • United Kingdom

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 NCT01646320 on ClinicalTrials.gov