Empagliflozin in patients with Type 1 Diabetes Mellitus (EASE-2).
Research type
Research Study
Full title
A Phase III, randomised, double blind, placebo-controlled, parallel group, efficacy, safety and tolerability trial of once daily, oral doses of Empagliflozin as Adjunctive to inSulin thErapy over 52 weeks in patients with Type 1 Diabetes Mellitus (EASE-2)
IRAS ID
177265
Contact name
Mark Evans
Contact email
Sponsor organisation
Boehringer Ingelheim
Eudract number
2014-001922-14
Duration of Study in the UK
1 years, 9 months, 12 days
Research summary
This is a Phase III, randomised, double blind, placebo-controlled, parallel group, efficacy, safety and tolerability trial of once daily, oral doses of Empagliflozin as Adjunctive to inSulin thErapy over 52 weeks in patients with Type 1 Diabetes Mellitus (known as the EASE-2 study).
The study will be conducted at about 135 study clinics/ hospitals worldwide. About 1440 patients will be screened for suitability and about 720 patients will go on to receive the study medication, with 240 patients assigned to each of the three treatment groups: Empagliflozin 10 mg, Empagliflozin 25 mg and Placebo.
Patients will be required to attend 16 scheduled clinic visits and one telephone visit over approximately 64 weeks. Each visit will take 1-2 hours to complete, depending on what has to be done. Recruitment is competitive. This study is divided into 5 parts:
i. Screening Period (Visit 1): to determine if the patients are eligible
ii Therapy Optimisation Period (Visits 2-4T): This period lasts for 6 weeks during which the patient's current treatment approach will be optimised.
iii. Placebo Run-in Period (Visit 5): in this 2 week period, all patients will take two placebo tablets The tablets will be taken in addition to insulin.
iv. Randomised Treatment Period (Visits 6-16): during this 52 week period, patients will receive study medication, either Empagliflozin or placebo, in addition to their insulin.
v. Follow-Up Period (Visit 17): 3 weeks after the patient has stopped taking the study drug, they will return for a final visit.REC name
East of England - Cambridge South Research Ethics Committee
REC reference
15/EE/0161
Date of REC Opinion
27 May 2015
REC opinion
Further Information Favourable Opinion