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18-week add-on to Metformin Comparison of Saxagliptin and Sitagliptin in Adult Patients With Type 2 Diabetes (T2D)

NCT00666458 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 822

Last updated 2010-04-15

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 assess the efficacy and tolerability of saxagliptin in addition to metformin and compare to sitagliptin in addition with metformin.

Conditions

Interventions

DRUG

saxagliptin

tablet, per oral, once daily

DRUG

sitagliptin

capsule, per oral, once daily

Sponsors & Collaborators

Principal Investigators

  • André Scheen, Professor · Clinical Pharmacology Unit, Liege, Belgium

  • Peter Öhman, MD, PhD · AstraZeneca, Wilmington, USA

  • Deborah Price, MSc · AstraZeneca, Wilmington, USA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2009-03-31
Completion
2009-03-31

Countries

  • Argentina
  • Belgium
  • Denmark
  • France
  • Italy
  • Mexico
  • Norway
  • South Africa
  • Sweden

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 NCT00666458 on ClinicalTrials.gov