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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-1)

Trial Profile

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-1)

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 11 Jun 2019

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At a glance

  • Drugs Empagliflozin (Primary)
  • Indications Type 1 diabetes mellitus
  • Focus Pharmacodynamics; Proof of concept
  • Acronyms EASE-1
  • Sponsors Boehringer Ingelheim Pharmaceuticals
  • Most Recent Events

    • 11 Jun 2019 Modeling and simulation data from studies EASE-1,2 and 3 were presented at the 79th Annual Scientific Sessions of the American Diabetes Association.
    • 18 Dec 2017 Results generating population pharmacokinetic pharmacodynamic model using data from this trial published in the Journal of Clinical Pharmacology.
    • 15 Sep 2017 Outcomes of a population PK-PD model using data from this trial designed to quantify the effect of the empagliflozin on renal glucose reabsorption in patients with type 1 diabetes and to compare results with analysis in patients with type 2 diabetes, presented at the 53rd Annual Meeting of the European Association for the Study of Diabetes.
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