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Efficacy and Safety of Dapagliflozin in Combination With Glimepiride (a Sulphonylurea) in Type 2 Diabetes Patients

NCT00680745 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 597

Last updated 2013-10-14

Study results available
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Summary

This study is being carried out to see if dapagliflozin in addition to glimepiride (sulphonylurea) is effective and safe in treating patients with type 2 diabetes when compared to glimepiride alone.

Conditions

Interventions

DRUG

dapagliflozin

tablet oral 2.5, 5, or 10 mg total daily dose once daily 48 weeks

DRUG

Glimepiride

tablet oral 2.5, 5, or 10 mg total daily dose once daily 48 weeks

DRUG

metformin hydrochloride

rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice

DRUG

pioglitazone hydrochloride

rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice

DRUG

Rosiglitazone

rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice

Sponsors & Collaborators

Principal Investigators

  • Krzysztof Strojek, Prof. Dr. · Silesian Medical University3-Maja 13/15, 41-800 Zabrze; Poland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2009-11-30
Completion
2010-05-31

Countries

  • Czechia
  • Hungary
  • Philippines
  • Poland
  • South Korea
  • Thailand
  • 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 NCT00680745 on ClinicalTrials.gov