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Safety and Efficacy of Saxagliptin Plus Insulin With or Without Metformin

NCT00757588 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 455

Last updated 2015-06-01

Study results available
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Summary

The purpose of this study is to compare the effects of saxagliptin with those of placebo as add-on therapy to insulin and insulin with metformin in improving glycemic control at 24 and 52 weeks.

Conditions

Interventions

DRUG

Saxagliptin, 5 mg + insulin

Saxagliptin, 5-mg tablets (plus stable insulin dose), given orally once daily (24 weeks short-term, 28 weeks long-term); participants stratified by use of stable metformin dose; flexible insulin dose (as needed for rescue)

DRUG

Placebo + insulin

Placebo tablets given orally once daily for 24 weeks (short-term period)+ insulin with metformin

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
78 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2010-04-30
Completion
2010-04-30

Countries

  • United States
  • Canada
  • France
  • Hungary
  • India
  • Mexico
  • Poland
  • Russia
  • South Africa
  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT00757588 on ClinicalTrials.gov