Efficacy and Safety of Dapagliflozin in Combination With Metformin in Type 2 Diabetes Patients

Phase 3

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: dapagliflozin; Drug: glipizide; Drug: metformin hydrochloride

• Registration Number: NCT00660907
• Lead Sponsor: AstraZeneca

Brief Summary

This study is being carried out to see if dapagliflozin as an addition to metformin is effective and safe in treating patients with type 2 diabetes when compared to glipizide (sulphonylurea) as an addition to metformin treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-04-15
• Study First Submitted QC: 2008-04-15
• Study First Posted: 2008-04-17
• Primary Completion: 2009-12
• Study Completion: 2013-01
• Results First Submitted: 2013-01-21
• Results First Submitted QC: 2013-07-19
• Results First Posted: 2013-08-23
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-10
• Last Update Posted: 2015-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1217

Inclusion Criteria

• Type 2 Diabetes
• Treated with oral anti-diabetic drug therapy therapy including Metformin for at least 8 weeks prior to enrolment
• HbA1c >6.5% and </=10%

Exclusion Criteria

• Type 1 Diabetes
• Insulin therapy within one year of enrolment
• Renal (kidney) failure or dysfunction

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	dapagliflozin	dapagliflozin plus metformin
2	glipizide	glipizide plus metformin
1	metformin hydrochloride	dapagliflozin plus metformin
2	metformin hydrochloride	glipizide plus metformin

Primary Outcome Measures

Name	Time	Method
Adjusted Mean Change in HbA1c Levels	Baseline to Week 52	To assess the effect of dapagliflozin plus metformin compared to glipizide plus metformin on the absolute change from baseline in HbA1c level after 52 weeks double-blind treatment in patients with type 2 diabetes who have inadequate glycaemic control on 1500 mg/day or higher doses of metformin therapy alone.

Secondary Outcome Measures

Name	Time	Method
Adjusted Mean Change in Body Weight	Baseline to Week 52	To assess the effect of dapagliflozin plus metformin compared to glipizide plus metformin on body weight after 52 weeks double-blind treatment.
Proportion of Participants With Body Weight Reduction of at Least 5%	Baseline to Week 52	To evaluate the effect of dapagliflozin plus metformin compared to glipizide plus metformin on body weight assessed by a reduction after 52 weeks of at least 5% compared to baseline. Least Squares Mean represents the percent of participants adjusted for baseline value.
Proportion of Participants With at Least One Episode of Hypoglycemia	Baseline to Week 52	To assess the effect of dapagliflozin plus metformin treatment compared to glipizide plus metformin on the occurrence of hypoglycemic events. Least Squares Mean represents the percent of participants adjusted for HbA1c baseline value.

Trial Locations

Locations (1)

Research Site; 🇬🇧 Trowbridge, United Kingdom