Evaluate Efficacy and Safety of Saxagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes

NCT00661362 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 570

Last updated 2012-03-08

Study results available
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Summary

Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to evaluate the efficacy and safety in adult patients who have inadequate glycaemic control when treated with metformin in addition to diet and exercise.

Conditions

Interventions

DRUG

Saxagliptin

Oral tablet, once daily for 24 weeks

DRUG

Placebo

oral tablet, once daily for 24 weeks

DRUG

Metformin

oral tablet, once daily for 24 weeks

Sponsors & Collaborators

Principal Investigators

  • Peter Ohman, MD · AstraZeneca

  • Deborah Price, MSc · AstraZeneca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2009-09-30
Completion
2009-09-30

Countries

  • China
  • India
  • South Korea

Study Locations

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Entities

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 NCT00661362 on ClinicalTrials.gov