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

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.

Status

Suspended

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01257412

Enrollment

375

Registered

2010-12-09

Start date

2012-01-31

Completion date

2013-06-30

Last updated

2012-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

Phase III, Type 2 Diabetes Mellitus, inadequate glycaemic control

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.

Interventions

DRUGDapagliflozin

5mg Oral dose od

DRUGplacebo

5/10 mg Oral dose od

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
change in glycosylated haemoglobin A1c (HbA1c).	From baseline to week 24

Secondary

Measure	Time frame
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

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026