MedTrace Logo

Safety and Efficacy of Combination Saxagliptin & Dapagliflozin Added to Metformin to Treat Subjects With Type 2 Diabetes

NCT01606007 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1282

Last updated 2017-05-15

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to learn if a combination of BMS-477118 (Saxagliptin) and BMS -512148 (Dapagliflozin) added to Metformin can improve (decrease) Glycosylated Hemoglobin (Hemoglobin A1c) in patients with type 2 diabetes after 24 weeks of treatment. The safety of this treatment will also be studied.

Conditions

Interventions

DRUG

Saxagliptin

Tablets, Oral, 5mg , Once daily, 24 weeks

DRUG

Metformin XR

Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks

DRUG

Dapagliflozin

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

DRUG

Placebo matching with Dapagliflozin

Tablets, Oral, 0mg, Once daily, 24 weeks

DRUG

Placebo matching with Saxagliptin

Tablets, Oral, 0mg, Once daily, 24 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
2012-07-31
Primary Completion
2014-01-31
Completion
2014-01-31

Countries

  • United States
  • Canada
  • Mexico
  • Poland
  • Puerto Rico
  • Romania
  • South Africa
  • 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 NCT01606007 on ClinicalTrials.gov