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

AstraZeneca

Status and phase: Suspended; Phase 3

Conditions: Type 2 Diabetes

Treatments: Drug: placebo; Drug: Dapagliflozin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01257412

D1693C00002

Details and patient eligibility

About

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.

Enrollment: 375 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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375 participants in 3 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: Dapagliflozin

Drug: Dapagliflozin

2

Experimental group

Treatment:

Drug: Dapagliflozin

Drug: Dapagliflozin

3

Placebo Comparator group

Treatment:

Drug: placebo