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A Study Assessing Saxagliptin Treatment in Type 2 Diabetic Subjects Who Are Not Controlled With TZD Therapy Alone

NCT00295633 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 565

Last updated 2015-04-07

Study results available
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Summary

The purpose of this clinical research study is to learn whether Saxagliptin added to thiazolidinedione (TZD) therapy is more effective than TZD alone as a treatment for Type 2 diabetic subjects who are not sufficiently controlled with TZD alone

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Saxagliptin

Tablets, Oral, 2.5 mg, Once daily (6 months ST, 12 months LT)

DRUG

Saxagliptin

Tablets, Oral, 5 mg, once daily (6 months ST, 12 months LT)

DRUG

Placebo

Tablets, Oral, 0 mg, Once daily (6 months ST, 12 months LT)

DRUG

pioglitazone

Tablets, Oral, 30 mg or 45 mg, once daily (6 months ST, 12 months LT)

DRUG

rosiglitazone

Tablets, Oral, 4 mg, once daily or 8 mg, either as once or twice daily (6 months ST, 12 months LT)

DRUG

metformin

Tablets, Oral, 500-2500 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
2006-03-31
Primary Completion
2007-10-31
Completion
2008-10-31

Countries

  • United States
  • Argentina
  • Canada
  • India
  • Mexico
  • Peru
  • Philippines
  • Puerto Rico

Study Locations

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Entities

Drugs
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 NCT00295633 on ClinicalTrials.gov