MedTrace Logo

Study of BMS-477118 as Monotherapy With Titration in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise

NCT00316082 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 365

Last updated 2015-04-29

Study results available
· View outcomes & findings →

Summary

The purpose of this trial is to understand if saxagliptin is more effective than placebo as a treatment for type 2 diabetic subjects who are not controlled with diet and exercise

Conditions

Interventions

DRUG

Saxagliptin

Coated tablets, Oral, 2.5 mg, QAM, Daily (6 months ST, 12 months LT)

DRUG

Saxagliptin

Coated tablets, Oral, 2.5 mg titrated to 5mg, QAM, Daily (6 months ST, 12 months LT)

DRUG

Saxagliptin

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

DRUG

Saxagliptin

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

DRUG

Placebo

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

DRUG

metformin

Tablets, Oral, 500-2000 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
2006-06-30
Primary Completion
2007-11-30
Completion
2008-11-30

Countries

  • United States
  • India
  • Russia
  • Taiwan

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 NCT00316082 on ClinicalTrials.gov