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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
75
Empagliflozin medium placebo
Empagliflozin low placebo
Empagliflozin low placebo
1245.78.43001 Boehringer Ingelheim Investigational Site
Graz, Austria
1245.78.49001 Boehringer Ingelheim Investigational Site
Neuss, Germany
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
Change of urinary glucose excretion (UGE) (g/24 h) from baseline (refers to the last measurement prior to the first intake of any randomised trial medication) after seven days of treatment with empagliflozin 2.5 mg, 10 mg, or 25 mg, or placebo. The treatment effect was estimated on the basis of the least square mean treatment difference at Day 7 extracted from the primary analysis model. The primary endpoint is exploratory.
Time frame: baseline (Day -1) and 7 days after first drug administration (Day 7)
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Empagliflozin high placebo
Empagliflozin medium
Empagliflozin medium placebo
Empagliflozin high placebo
Empagliflozin high placebo
Empagliflozin medium placebo
Empagliflozin low placebo
Empagliflozin low
Empagliflozin high