Status:

COMPLETED

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

Lead Sponsor:

AstraZeneca

Collaborating Sponsors:

Bristol-Myers Squibb

Conditions:

Type 2 Diabetes

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief 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.

Eligibility Criteria

Inclusion

  • Type 2 Diabetes
  • Treatment with a stable sulphonylurea monotherapy dose that is at least half the maximal recommended dose for a minimum of 8 weeks prior to study
  • Inadequate glycaemic control, defined as A1C ≥ 7.0 % and ≤ 10%

Exclusion

  • Type 1 Diabetes
  • Hepatic (liver) impairment
  • Renal (kidney) failure or dysfunction

Key Trial Info

Start Date :

April 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 1 2010

Estimated Enrollment :

597 Patients enrolled

Trial Details

Trial ID

NCT00680745

Start Date

April 1 2008

End Date

May 1 2010

Last Update

October 14 2013

Active Locations (66)

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Page 1 of 17 (66 locations)

1

Research Site

Blansko, Czechia

2

Research Site

Bruntál, Czechia

3

Research Site

Břeclav, Czechia

4

Research Site

Hodonín, Czechia

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