Evaluation of Efficacy and Safety of Dapagliflozin as Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control With Diet and Exercise Alone

Phase 3

Suspended

• Conditions: Type 2 Diabetes
• Interventions: Drug: placebo; Drug: Dapagliflozin

• Registration Number: NCT01257412
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-12-08
• Study First Submitted QC: 2010-12-08
• Study First Posted: 2010-12-09
• Study Start: 2012-01
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-29
• Last Update Posted: 2012-03-01
• Primary Completion: 2013-06
• Study Completion: 2013-06

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 375

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	placebo	-
1	Dapagliflozin	-
2	Dapagliflozin	-

Primary Outcome Measures

Name	Time	Method
change in glycosylated haemoglobin A1c (HbA1c).	From baseline to week 24

Secondary Outcome Measures

Name	Time	Method
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
mean change from baseline in fasting plasma glucose (FPG)	From baseline to week 1

Trial Locations

Locations (1)

Research Site; 🇮🇳 Ghaziabad, Uttar Pradesh, India