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Study To Evaluate 24 Hour Blood Sugar Control (24-hour Mean Weighted Glucose) In Subjects That Are Taking Saxagliptin 5 mg Added Onto Metformin XR 1500 XR mg Compared To Subjects Taking Metformin XR 1500 mg Up-titrated To Metformin XR 2000 mg

NCT00918138 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 219

Last updated 2015-05-21

Study results available
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Summary

The purpose of this study was to compare effect of Saxagliptin as add-on to Metformin on 24-hour mean weighted glucose (MWG) to the effect of uptitrating Metformin in subjects with T2DM inadequately controlled on metformin alone.

Conditions

Interventions

DRUG

Saxagliptin

Tablets, Oral, 5 mg, once daily, 4 weeks

DRUG

Metformin XR

Tablets, Oral, 1500 mg, once daily, 4 weeks

DRUG

Placebo matching Metformin XR

Tablets, Oral, 0 mg, once daily, 4 weeks

DRUG

Metformin XR

Tablets, Oral, 500 mg, once daily, 4 weeks

DRUG

Placebo matching Saxagliptin

Tablets, Oral, 0 mg, once daily, 4 weeks

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
78 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2010-05-31
Completion
2010-05-31

Countries

  • United States
  • Argentina
  • Israel
  • Mexico

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 NCT00918138 on ClinicalTrials.gov