Phase III Insulin Add-On Asia Regional Program - ST

Sponsor
AstraZeneca
Study ID
NCT02096705
Phase
PHASE3
Status
Completed

Conditions

  • Diabetes

Eligibility Criteria

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

Interventions

Study Details

The purpose is to determine if after 24 weeks of oral daily administration, there will be a greater mean reduction from baseline in glycosylated hemoglobin (HbA1c) achieved with Dapagliflozin 10 mg plus insulin compared to placebo plus insulin in subjects with type 2 diabetes.

Key Dates

Start date
Mar 31, 2014
Status verified
Jul 2017
Primary completion
Jan 28, 2016
Completion
Jan 28, 2016

Study Design

Enrollment
477 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1: Dapagliflozin
    Dapagliflozin 10 mg oral Tablet once daily for 24 weeks + Background Insulin
  • Placebo Comparator: Group 2: Dapagliflozin Placebo
    Dapagliflozin Placebo 0 mg oral Tablet once daily for 24 weeks + Background Insulin

Primary Outcome Measure

Adjusted Mean Change in HbA1c From Baseline to Week 24 [ Time Frame: Baseline (Day 1) and 24 weeks ]

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