Empagliflozin add-on to Insulin in Type 1 Diabetes Mellitus Over 28 Days

Sponsor
Boehringer Ingelheim
Study ID
NCT01969747
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

Placebo-controlled, double blind (triple-dummy technique), randomised parallel design comparison of three oral doses (2.5 mg, 10 mg, and 25 mg) of empagliflozin in patients with T1DM as adjunctive therapy to insulin over 28 days. Patients will undergo a 14-day open-label placebo run-in period before randomisation. Background insulin therapy will be kept stable during the first 7 days of the treatment period and will be freely adjusted thereafter.

Key Dates

Start date
Nov 30, 2013
Status verified
Apr 2015
Primary completion
Apr 30, 2014
Completion
Apr 30, 2014

Study Design

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

Arms

  • Experimental: Empagliflozin low
    Empagliflozin low once daily
  • Experimental: Empagliflozin medium
    Empagliflozin medium once daily
  • Experimental: Empagliflozin high
    Empagliflozin high once daily
  • Placebo Comparator: Placebo
    Placebo once daily

Primary Outcome Measure

Change From Baseline in 24 h UGE (g/24 h) After Seven Days of Treatment With Empagliflozin 2.5 mg, 10 mg, or 25 mg, or Placebo [ Time Frame: baseline (Day -1) and 7 days after first drug administration (Day 7) ]

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