At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 2 clinical trial evaluating Empagliflozin medium placebo, Empagliflozin low placebo, and 4 other interventions for Diabetes Mellitus, Type 1. Completed, enrolled 75 participants across 2 sites in 2 countries.
Detailed 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 Details
Timeline
Interventions
Empagliflozin medium placebo
Empagliflozin low placebo
Empagliflozin low placebo
Empagliflozin high placebo
Empagliflozin medium
Empagliflozin medium placebo
Empagliflozin high placebo
Empagliflozin high placebo
Empagliflozin medium placebo
Empagliflozin low placebo
Empagliflozin low
Empagliflozin high