A 28-day Randomised, Placebo-controlled, Double-blind Parallel Group Phase IIa Trial to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Once Daily Oral Doses of 2.5 mg, 10 mg, and 25 mg Empagliflozin as Adjunctive to Insulin in Patients With Type 1 Diabetes Mellitus (EASE-2)
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 75
- Locations
- 2
- Primary Endpoint
- 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
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Empagliflozin low
Empagliflozin low once daily
Intervention: Empagliflozin low (Drug)
Empagliflozin low
Empagliflozin low once daily
Intervention: Empagliflozin medium placebo (Drug)
Empagliflozin low
Empagliflozin low once daily
Intervention: Empagliflozin high placebo (Drug)
Empagliflozin medium
Empagliflozin medium once daily
Intervention: Empagliflozin low placebo (Drug)
Empagliflozin medium
Empagliflozin medium once daily
Intervention: Empagliflozin high placebo (Drug)
Empagliflozin medium
Empagliflozin medium once daily
Intervention: Empagliflozin medium (Drug)
Empagliflozin high
Empagliflozin high once daily
Intervention: Empagliflozin medium placebo (Drug)
Empagliflozin high
Empagliflozin high once daily
Intervention: Empagliflozin low placebo (Drug)
Empagliflozin high
Empagliflozin high once daily
Intervention: Empagliflozin high (Drug)
Placebo
Placebo once daily
Intervention: Empagliflozin low placebo (Drug)
Placebo
Placebo once daily
Intervention: Empagliflozin high placebo (Drug)
Placebo
Placebo once daily
Intervention: Empagliflozin medium placebo (Drug)
Outcomes
Primary Outcomes
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)
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.
Secondary Outcomes
No secondary outcomes reported