Evaluation of Dapagliflozin Taken Twice-daily

Phase 3

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: dapagliflozin; Drug: placebo; Drug: metformin

• Registration Number: NCT01217892
• Lead Sponsor: AstraZeneca

Brief Summary

This study is being carried out to see if dapagliflozin - administered in a daily dose of 2.5 mg given twice a day or 5 mg twice a day or 10mg once daily - in addition to metformin, is beneficial in diabetes treatment, and if so, how it compares to treatment with metformin alone.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-10-07
• Study First Submitted QC: 2010-10-07
• Study First Posted: 2010-10-08
• Study Start: 2010-11
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Results First Submitted: 2013-01-21
• Results First Submitted QC: 2013-10-31
• Results First Posted: 2013-11-01
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-16
• Last Update Posted: 2014-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Provision of informed consent prior to any study specific procedures
• Diagnosis of T2DM
• Current antihyperglycaemic treatment with metformin immediate release formulation monotherapy >/= 1500 mg/day at a stable dose for at least 10 weeks prior to enrolment. Other treatment with OADs within the 10 weeks prior to enrolment is not permitted.
• HbA1c ≥ 6.7% and ≤10.5%, based on central laboratory values from Screening Visit, and Enrolment Visit 1.

Exclusion Criteria

• Diagnosis of Type 1 diabetes mellitus, known diagnosis of Maturity Onset Diabetes of the Young (MODY) or secondary causes of diabetes mellitus
• History of diabetic ketoacidosis
• Symptoms of poorly controlled diabetes including, but not limited to, marked polyuria, polydipsia, and/or greater than 10% weight loss during the 3 months prior to enrolment
• FPG >270 mg/dL (>15.0 mmol/L)
• BMI >45 kg/m2

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4	placebo	Placebo plus open-label metformin
3	dapagliflozin	Dapagliflozin 10 mg once-daily plus open-label metformin
1	dapagliflozin	Dapagliflozin 2.5 mg twice-daily plus open-label metformin
1	metformin	Dapagliflozin 2.5 mg twice-daily plus open-label metformin
3	metformin	Dapagliflozin 10 mg once-daily plus open-label metformin
2	dapagliflozin	Dapagliflozin 5.0 mg twice-daily plus open-label metformin
2	metformin	Dapagliflozin 5.0 mg twice-daily plus open-label metformin
4	metformin	Placebo plus open-label metformin

Primary Outcome Measures

Name	Time	Method
Adjusted Mean Change in HbA1c Levels	Baseline to Week 16	To compare the change from baseline in HbA1c achieved with each of the 2 BID doses of dapagliflozin (2.5 mg BID and 5 mg BID) co-administered with metformin versus placebo co-administered with metformin after 16 weeks of double-blind treatment.

Secondary Outcome Measures

Name	Time	Method
Adjusted Mean Change in Fasting Plasma Glucose (FPG) From Baseline to Week 16	Baseline to Week 16	To compare the change from baseline in fasting plasma glucose (FPG) achieved with each of the 2 BID doses of dapagliflozin (2.5 mg BID and 5 mg BID) co-administered with metformin versus placebo co-administered with metformin after 16 weeks of double-blind treatment.
Adjusted Percent Change in Body Weight	Baseline to Week 16	To compare the percent change from baseline in body weight achieved with each of the 2 BID doses of dapagliflozin (2.5 mg BID, and 5 mg BID) co-administered with metformin versus placebo co-administered with metformin after 16 weeks of double-blind treatment.
Adjusted Mean Change in Fasting Plasma Glucose (FPG) From Baseline to Week 1	Baseline to Week 1	To compare the change from baseline in fasting plasma glucose (FPG) achieved with each of the 2 BID doses of dapagliflozin (2.5 mg BID and 5 mg BID) co-administered with metformin versus placebo co-administered with metformin after 1 week of double-blind treatment.
Proportion of Participants With HbA1c<7.0% at Week 16, in Participants Who Had HbA1c ≥7.0% at Baseline.	Baseline to Week 16	To compare the adjusted proportions controlling for baseline HbA1c \[acc. to Zhang, Tsiatis \& Davidian and Davidian, Tsiatis, Zhang \& Lu\] of participants with HbA1c \<7.0% achieved with each of the 2 BID doses of dapagliflozin (2.5 mg BID and 5 mg BID) co-administered with metformin versus placebo co-administered with metformin after 16 weeks of double-blind treatment, in patients who had HbA1c ≥7.0% at baseline.

Trial Locations

Locations (1)

Research Site; 🇺🇦 Zaporozhye, Ukraine