Evaluation of Dapagliflozin Taken Twice-daily

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes

Treatments: Drug: dapagliflozin; Drug: metformin; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01217892

D1691C00003

Details and patient eligibility

About

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.

Enrollment: 400 patients

Sex: All

Ages: 18 to 77 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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400 participants in 4 patient groups, including a placebo group

1

Experimental group

Description:

Dapagliflozin 2.5 mg twice-daily plus open-label metformin

Treatment:

Drug: dapagliflozin

Drug: dapagliflozin

Drug: dapagliflozin

Drug: metformin

2

Experimental group

Description:

Dapagliflozin 5.0 mg twice-daily plus open-label metformin

Treatment:

Drug: dapagliflozin

Drug: dapagliflozin

Drug: dapagliflozin

Drug: metformin

3

Experimental group

Description:

Dapagliflozin 10 mg once-daily plus open-label metformin

Treatment:

Drug: dapagliflozin

Drug: dapagliflozin

Drug: dapagliflozin

Drug: metformin

4

Placebo Comparator group

Description:

Placebo plus open-label metformin

Treatment:

Drug: placebo

Drug: metformin