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Evaluation of the Effect of Dapagliflozin in Combination With Metformin on Body Weight in Subjects With Type 2 Diabetes

NCT00855166 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 182

Last updated 2013-10-14

Study results available
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Summary

This study is being carried out to see if dapagliflozin in addition to metformin decreases body weight and if so, how it compares with metformin alone.

Conditions

Interventions

DRUG

Dapagliflozin

Tablet oral 10 mg total daily dose once daily 102 weeks

DRUG

Metformin

Tablet oral 1500 - 2500 mg total daily dose 1-3 times a day104 weeks

DRUG

Sitagliptin

Tablet oral 100 mg total daily dose once daily rescue medication

DRUG

Placebo

Matching placebo for dapagliflozin, tablet, oral, once daily, 102 weeks

Sponsors & Collaborators

Principal Investigators

  • Jan Bolinder, MD, PhD · Dept of Endocrinology, Metabolism and Diabetes Karolinska University Hospital Huddinge Karolinska Institutet 141 86 Stockholm Sweden

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2010-06-30
Completion
2011-12-31

Countries

  • Bulgaria
  • Czechia
  • Hungary
  • Poland
  • Sweden

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 NCT00855166 on ClinicalTrials.gov