Completed

Dapagliflozin and Glimepiride Combination for Type 2 Diabetes Treatment

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Study Aim

This study aims to evaluate the effectiveness of combining Dapagliflozin with Glimepiride, compared to a placebo, in improving blood sugar control for individuals with Type 2 Diabetes, as measured by changes in HbA1c levels over a 24-week treatment period.

What is being tested

dapagliflozin

+ Glimepiride

+ metformin hydrochloride

Drug
Who is being recruted

Diabetes Mellitus+3

+ Diabetes Mellitus, Type 2

+ Endocrine System Diseases

Over 18 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 3
Interventional
Study Start: April 2008
See protocol details

Summary

Principal SponsorAstraZeneca
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2008

Actual date on which the first participant was enrolled.

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.

Official TitleA 24-Week,Int.,Rand.,Double-blind,Parallel-group,Multi-centre, Plac.-Controlled Phase III Study With a 24-Wk Ext.Per.to Eval.the Efficacy and Safety of Dapagliflozin in Comb.With Glimepiride (a Sulphonylurea) in Subjects With Type2 Diab.Who Have Inadeq. Glycaemic Control on Glimepiride Therapy Alone
NCT00680745
Principal SponsorAstraZeneca
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

597 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diabetes MellitusDiabetes Mellitus, Type 2Endocrine System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism Disorders

Criteria

3 inclusion criteria required to participate
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%
3 exclusion criteria prevent from participating
Type 1 Diabetes
Hepatic (liver) impairment
Renal (kidney) failure or dysfunction

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

25% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
dapagliflozin 2.5mg + Glimepiride

Group II

Experimental
dapagliflozin 5mg + Glimepiride

Group III

Experimental
dapagliflozin 10mg + Glimepiride

Group IV

Placebo
Placebo + Glimepiride

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 66 locations

Suspended

Research Site

Blansko, CzechiaOpen Research Site in Google Maps
Suspended

Research Site

Bruntál, Czechia
Suspended

Research Site

Břeclav, Czechia
Suspended

Research Site

Hodonín, Czechia
Completed66 Study Centers