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

Sponsor
AstraZeneca
Study ID
NCT01257412
Phase
PHASE3
Status
Suspended

Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Jan 31, 2012
Status verified
Feb 2012
Primary completion
Jun 30, 2013
Completion
Jun 30, 2013

Study Design

Enrollment
375 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1
  • Experimental: 2
  • Placebo Comparator: 3

Primary Outcome Measure

change in glycosylated haemoglobin A1c (HbA1c). [ Time Frame: From baseline to week 24 ]

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