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A Phase 3 Study of BMS-477118 in Combination With Metformin in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise

NCT00327015 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1306

Last updated 2015-04-29

Study results available
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Summary

The purpose of this trial is to understand if adding saxagliptin to metformin therapy is safe and works better than taking either saxagliptin or metformin alone

Conditions

Interventions

DRUG

Saxagliptin

Coated Tablets, Oral, 10 mg, Daily (6 months ST, 12 months LT)

DRUG

Saxagliptin

Coated tablets, PO, 5 mg, Daily (6 months ST, 12 months LT)

DRUG

Metformin

Coated tablets, Oral, 500 mg, Daily (6 months ST, 12 months LT)

DRUG

Placebo

Coated tablets, Oral, 0 mg, Daily (6 months ST, 12 months LT)

DRUG

pioglitazone

Tablets, Oral, 15-45 mg, as needed (12 months LT)

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
2006-05-31
Primary Completion
2007-11-30
Completion
2008-12-31

Countries

  • United States
  • Argentina
  • Brazil
  • Germany
  • Hungary
  • India
  • Italy
  • Mexico
  • Philippines
  • Poland
  • Puerto Rico
  • Russia
  • Ukraine

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 NCT00327015 on ClinicalTrials.gov