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Evaluate Efficacy and Safety in Japanese Subjects With Type 2 Diabetes Mellitus

NCT01294423 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 261

Last updated 2014-07-24

Study results available
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Summary

This is a 24-week randomised, multi-centre phase III study to evaluate the efficacy and safety of dapagliflozin as monotherapy in Japanese subjects with Type 2 diabetes mellitus who have inadequate glycemic control with diet and exercise.

Conditions

Interventions

DRUG

Dapagliflozin

Dapagliflozin 5mg/matching placebo for Dapagliflozin 10mg oral dose

DRUG

Dapagliflozin

Dapagliflozin 10mg/matching placebo for Dapagliflozin 5mg oral dose

DRUG

Placebo

Matching placebo for Dapagliflozin 5mg/10mg oral dose

Sponsors & Collaborators

Principal Investigators

  • Jisin Yang, MD · AstraZeneca KK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2012-03-31
Completion
2012-03-31

Countries

  • Japan

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 NCT01294423 on ClinicalTrials.gov