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52-week add-on to Metformin Comparison of Saxagliptin and Sulphonylurea, With a 52-week Extension Period

NCT00575588 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 891

Last updated 2012-03-21

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 sulphonylurea in addition with metformin.

Conditions

Interventions

DRUG

Metformin

open-label metformin

DRUG

Sulphonylurea

Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks)

DRUG

Saxagliptin

Saxagliptin 5 mg tablets

Sponsors & Collaborators

Principal Investigators

  • Burkhard Goke · University of Munich, Germany

  • 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
2007-12-31
Primary Completion
2009-08-31
Completion
2010-08-31

Countries

  • Finland
  • Germany
  • Hungary
  • India
  • Netherlands
  • Norway
  • Russia
  • Slovakia
  • South Korea
  • United Kingdom
  • Vietnam

Study Locations

More Related Trials

Entities

Drugs
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 NCT00575588 on ClinicalTrials.gov