Efficacy and Safety of Dapagliflozin in Combination With Glimepiride (a Sulphonylurea) in Type 2 Diabetes Patients

Sponsor
AstraZeneca
Study ID
NCT00680745
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • dapagliflozin — DRUG
    tablet oral 2.5, 5, or 10 mg total daily dose once daily 48 weeks
  • Glimepiride — DRUG
    tablet oral 2.5, 5, or 10 mg total daily dose once daily 48 weeks
  • metformin hydrochloride — DRUG
    rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice
  • pioglitazone hydrochloride — DRUG
    rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice
  • Rosiglitazone — DRUG
    rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice

Study Details

This study is being carried out to see if dapagliflozin in addition to glimepiride (sulphonylurea) is effective and safe in treating patients with type 2 diabetes when compared to glimepiride alone.

Key Dates

Start date
Apr 30, 2008
Status verified
Aug 2013
Primary completion
Nov 30, 2009
Completion
May 31, 2010

Study Design

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

Arms

  • Experimental: 1
    dapagliflozin 2.5mg + Glimepiride
  • Experimental: 2
    dapagliflozin 5mg + Glimepiride
  • Experimental: 3
    dapagliflozin 10mg + Glimepiride
  • Placebo Comparator: 4
    Placebo + Glimepiride

Primary Outcome Measure

Adjusted Mean Change in HbA1c Levels [ Time Frame: Baseline to Week 24 ]

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