MedTrace Logo

Evaluation of Safety and Efficacy of Dapagliflozin in Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Background Combination of Metformin and Sulfonylurea

NCT01392677 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 311

Last updated 2014-03-12

Study results available
· View outcomes & findings →

Summary

This study intends to compare the efficacy and safety of dapagliflozin versus placebo in patients with type 2 diabetes who have inadequate glycaemic control on a background combination of metformin and sulfonylurea.

Conditions

Interventions

DRUG

dapagliflozin

10 mg tablet, oral, once daily, 24- week treatment and 28- week extension period

DRUG

placebo

matching placebo tablet, oral, once daily, 24- week treatment and 28- week extension period

Sponsors & Collaborators

Principal Investigators

  • Eva Johnsson, PhD, Medical Science Director · AstraZeneca R&D, Global Medicines Development CVGI, SE-431 83 Mölndal, Sweden

  • Stephan Matthaei, Prof.Dr.med · Diabetes-Zentrum Quakenbruck

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2013-01-31
Completion
2013-08-31

Countries

  • Canada
  • Czechia
  • Germany
  • Poland
  • Slovakia
  • Spain

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 NCT01392677 on ClinicalTrials.gov