Evaluation of Dapagliflozin Taken Twice-daily

AstraZeneca400 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

400

Conditions

Type 2 Diabetes

Interventions

dapagliflozinDRUG

2.5 mg tablet, taken orally, twice daily

dapagliflozinDRUG

5 mg tablet taken orally, twice daily

dapagliflozinDRUG

10 mg tablet taken orally, once daily

metformin

Eligibility

Sex: ALLMin age: 18 YearsMax age: 77 Years

Medical Language ↔ Plain English

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

Locations (55)

Outcomes

Primary Outcomes

Adjusted Mean Change in HbA1c Levels

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.

Time frame: Baseline to Week 16

Secondary Outcomes

Adjusted Percent Change in Body Weight

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.

Time frame: Baseline to Week 16

Adjusted Mean Change in Fasting Plasma Glucose (FPG) From 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.

Time frame: Baseline to Week 1

Adjusted Mean Change in Fasting Plasma Glucose (FPG) From Baseline to Week 16

Time frame: Baseline to Week 16

Proportion of Participants With HbA1c<7.0% at Week 16, in Participants Who Had HbA1c ≥7.0% at Baseline.

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.

Data from ClinicalTrials.gov

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Research Site

Aßlar, Germany

Research Site

Berlin, Germany

Research Site

Biberach A.d. Riss, Germany

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Bosenheim, Germany

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Dippoldiswalde, Germany

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Falkensee, Germany

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Meissen, Germany

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München, Germany

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Neuwied, Germany

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Pirna, Germany

...and 45 more locations