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An 18 Week Efficacy and Safety Study of Saxagliptin and Metformin XR Combination in Subjects With Type 2 Diabetes

NCT00960076 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 282

Last updated 2011-09-27

Study results available
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Summary

The purpose of this study is to compare reduction in A1C for subjects taking Saxagliptin and Metformin XR vs. uptitrated Metformin XR.

Conditions

Interventions

DRUG

Saxagliptin

5mg oral tablet once daily

DRUG

Metformin XR

500mg oral tablet once daily

DRUG

Metformin XR

750mg, 2 tablets once daily

Sponsors & Collaborators

Principal Investigators

  • Boaz Hirschberg, MD · AstraZeneca

  • Vivian Fonseca, MD · Tulane University

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
2010-10-31
Completion
2010-10-31

Countries

  • United States
  • Colombia
  • Costa Rica
  • Mexico
  • Peru

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 NCT00960076 on ClinicalTrials.gov