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Efficacy and Safety of Dapagliflozin, Added to Therapy of Patients With Type 2 Diabetes With Inadequate Glycemic Control on Insulin

NCT00673231 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1240

Last updated 2013-10-29

Study results available
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Summary

This study is being carried out to see if Dapagliflozin in addition to insulin is effective and safe in treating patients with type 2 diabetes when compared to placebo (identical looking inactive treatment) in addition to insulin

Conditions

Interventions

DRUG

Dapagliflozin

tablet oral 2.5 mg total daily dose once daily 48 weeks (= 24 week randomised treatment period + 24 week study extension period I)

DRUG

Dapagliflozin

Tablet oral 5 mg total daily dose once daily 48 weeks (= 24 week randomised treatment period + 24 week study extension period I)

DRUG

Dapagliflozin

Tablet oral 10 mg total daily dose once daily 48 weeks (= 24 week randomised treatment period + 24 week study extension period I)

DRUG

Placebo

Placebo

DRUG

Dapagliflozin

tablet oral 2.5 total daily dose once daily 56 weeks (= 56 week study extension period II)

DRUG

Dapagliflozin

tablet oral 10 mg total daily dose once daily 56 weeks (= 56 week study extension period II)patients that have been treated with 5 mg during the 24 week randomised treatment period and extension I period will during extension II period switched to 10 mg

Sponsors & Collaborators

Principal Investigators

  • John Wilding, MD · Clinical Sciences CentreUniversity Hospital AintreeLongmoor LaneLiverpool, UK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2009-05-31
Completion
2011-01-31

Countries

  • United States
  • Austria
  • Bulgaria
  • Canada
  • Finland
  • Germany
  • Hungary
  • Netherlands
  • Romania
  • Russia
  • Slovakia
  • Spain
  • United Kingdom

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 NCT00673231 on ClinicalTrials.gov