A 24-week National Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase III Trial in India to Evaluate the Efficacy and Safety of Dapagliflozin as Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control With Diet and Exercise Alone.

AstraZeneca1 site in 1 country375 target enrollmentJanuary 2012

ConditionsType 2 Diabetes

InterventionsDapagliflozin placebo

DrugsDapagliflozin placebo

Overview

Phase: Phase 3
Intervention: Dapagliflozin
Conditions: Type 2 Diabetes
Sponsor: AstraZeneca
Enrollment: 375
Locations: 1
Primary Endpoint: change in glycosylated haemoglobin A1c (HbA1c).
Status: Suspended
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study intends to compare the efficacy and safety of dapagliflozin versus placebo in treatment-naïve subjects with type 2 diabetes who have inadequate glycaemic control with diet and exercise alone.

Registry

clinicaltrials.gov

Start Date

January 2012

End Date

June 2013

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AstraZeneca

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Provision of informed consent before participating in the study
•Diagnosed with type 2 diabetes (high blood sugar); HbA1c ≥ 7.2% and ≤10.0%
•Subjects should be drug naïve
•Women of childbearing potential who comply to use an adequate method of contraception to avoid pregnancy throughout the study \& who have a negative serum or urine pregnancy test

Exclusion Criteria

•Subjects received Insulin therapy within one year of enrollment
•Subjects who have severe uncontrolled hypertension
•Subjects who have history of unstable or rapidly progressing renal disease
•Subjects who have severe liver disease
•Subjects who receiving treatment for Human immunodeficiency virus (HIV)

Arms & Interventions

1

Intervention: Dapagliflozin

2

Intervention: Dapagliflozin

3

Intervention: placebo

Outcomes

Primary Outcomes

change in glycosylated haemoglobin A1c (HbA1c).

Time Frame: From baseline to week 24

Secondary Outcomes

mean change from baseline in fasting plasma glucose (FPG)(From baseline to week 1)
mean change in fasting plasma glucose (FPG)(From baseline to week 24)
mean change in 2- hour postprandial glucose by Mixed Meal Test(From baseline to week 24)