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Evaluation of Dapagliflozin Taken Twice-daily

NCT01217892 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2014-10-27

Study results available
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Summary

This study is being carried out to see if dapagliflozin - administered in a daily dose of 2.5 mg given twice a day or 5 mg twice a day or 10mg once daily - in addition to metformin, is beneficial in diabetes treatment, and if so, how it compares to treatment with metformin alone.

Conditions

Interventions

DRUG

dapagliflozin

2.5 mg tablet, taken orally, twice daily

DRUG

dapagliflozin

5 mg tablet taken orally, twice daily

DRUG

dapagliflozin

10 mg tablet taken orally, once daily

DRUG

metformin

\>/= 1500 mg total daily dose, tablets taken orally, twice daily

DRUG

placebo

placebo

Sponsors & Collaborators

Principal Investigators

  • Shamik Parikh · AstraZeneca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
77 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2011-08-31
Completion
2011-08-31

Countries

  • Germany
  • Hungary
  • Romania
  • Slovakia
  • South Africa
  • Switzerland
  • Ukraine

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 NCT01217892 on ClinicalTrials.gov