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Study of Multiple Doses of Saxagliptin (BMS-477118)

NCT00950599 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 423

Last updated 2015-04-03

Study results available
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Summary

To evaluate the positive efficacy trend among doses of saxagliptin (BMS-477118) in subjects with Type 2 diabetes mellitus by assessing the change from baseline in HbA1c following 12 weeks of double-blind treatment.

Conditions

Interventions

DRUG

Saxagliptin

Tablets, Oral, 2.5 mg, once daily, 12 weeks

DRUG

Saxagliptin

Tablets, Oral, 5 mg, once daily, 12 weeks

DRUG

Saxagliptin

Tablets, Oral, 10 mg, once daily, 12 weeks

DRUG

Saxagliptin

Tablets, Oral, 20 mg, once daily, 12 weeks

DRUG

Saxagliptin

Tablets, Oral, 40 mg, once daily, 12 weeks

DRUG

Saxagliptin

Tablets, Oral, 100 mg, once daily, 6 weeks

DRUG

Placebo

Tablets, Oral, 0 mg, once daily, 6 and 12 weeks

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-05-31
Primary Completion
2004-05-31
Completion
2004-05-31

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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 NCT00950599 on ClinicalTrials.gov