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

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes

Treatments: Drug: dapagliflozin; Drug: pioglitazone hydrochloride; Drug: Glimepiride; Drug: metformin hydrochloride; Drug: Rosiglitazone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00680745

D1690C00005

Details and patient eligibility

About

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.

Enrollment: 597 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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597 participants in 4 patient groups, including a placebo group

1

Experimental group

Description:

dapagliflozin 2.5mg + Glimepiride

Treatment:

Drug: Rosiglitazone

Drug: metformin hydrochloride

Drug: Glimepiride

Drug: dapagliflozin

Drug: pioglitazone hydrochloride

2

Experimental group

Description:

dapagliflozin 5mg + Glimepiride

Treatment:

Drug: Rosiglitazone

Drug: metformin hydrochloride

Drug: Glimepiride

Drug: dapagliflozin

Drug: pioglitazone hydrochloride

3

Experimental group

Description:

dapagliflozin 10mg + Glimepiride

Treatment:

Drug: Rosiglitazone

Drug: metformin hydrochloride

Drug: Glimepiride

Drug: dapagliflozin

Drug: pioglitazone hydrochloride

4

Placebo Comparator group

Description:

Placebo + Glimepiride

Treatment:

Drug: Rosiglitazone

Drug: metformin hydrochloride

Drug: Glimepiride

Drug: pioglitazone hydrochloride