MedTrace Logo

Glycemic Efficacy and Renal Safety Study of Dapagliflozin in Subjects With Type 2 Diabetes Mellitus and Moderate Renal Impairment

NCT00663260 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 631

Last updated 2017-02-10

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to determine whether dapagliflozin is effective in the treatment of type 2 diabetes in subjects with poor blood sugar control and moderate renal impairment

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Dapagliflozin

Tablets, Oral, 10 mg, Once Daily, 104 weeks

DRUG

Dapagliflozin

Tablets, Oral, 5 mg, Once Daily, 104 weeks

DRUG

Placebo

Tablets, Oral, 0 mg, Once Daily, 104 weeks

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2009-12-31
Completion
2011-06-30

Countries

  • United States
  • Argentina
  • Australia
  • Canada
  • Denmark
  • France
  • India
  • Italy
  • Mexico
  • Peru
  • Puerto Rico
  • Singapore
  • Spain

Study Locations

More Related Trials

Entities

Drugs
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 NCT00663260 on ClinicalTrials.gov