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Efficacy and Safety of Dapagliflozin in Combination With Metformin in Type 2 Diabetes Patients

NCT00660907 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1217

Last updated 2015-03-30

Study results available
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Summary

This study is being carried out to see if dapagliflozin as an addition to metformin is effective and safe in treating patients with type 2 diabetes when compared to glipizide (sulphonylurea) as an addition to metformin treatment.

Conditions

Interventions

DRUG

dapagliflozin

Tablet oral 2.5, 5, or 10 mg total daily dose once daily 208 weeks

DRUG

glipizide

Capsule oral 5, 10, or 20 mg total daily dose once or split/twice daily 208 weeks

DRUG

metformin hydrochloride

Tablet oral 1500, 2000, or 2500 mg total daily dose split/twice daily 218 weeks

Sponsors & Collaborators

Principal Investigators

  • Michael A. Nauck, Prof. Dr. med. · Diabeteszentrum Bad Lauterberg, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2009-12-31
Completion
2013-01-31

Countries

  • Argentina
  • France
  • Germany
  • Italy
  • Mexico
  • Netherlands
  • South Africa
  • Spain
  • Sweden
  • United Kingdom

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 NCT00660907 on ClinicalTrials.gov