Empagliflozin as adjunctive to insulin in Type 1 Diabetes (EASE-3)

• 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 26 weeks in patients with Type 1 Diabetes Mellitus (EASE-3).

• IRAS ID

  187779

• Contact name

  Pratik Choudhary

• Contact email

  pratik.choudhary@kcl.ac.uk

• Sponsor organisation

  Boehringer Ingelheim

• Eudract number

  2014-005256-26

• Duration of Study in the UK

  1 years, 4 months, 2 days

• Research summary

  This is a multi-national, randomised, placebo-controlled, double-blind, parallel group study that compares 3 doses of empagliflozin (2.5 mg, 10 mg and 25 mg) to placebo in patients with Type 1 Diabetes Mellitus l (T1DM) as an "add-on" to insulin therapy.

  The study will be conducted at about 200 study clinics/ hospitals worldwide. About 1920 patients will be screened for suitability and about 960 patients will go on to receive the study medication, with 240 patients assigned to each of the
  treatment groups.

  The randomised treatment will be double-blind. A triple-dummy design will be used for masking the treatment assignment, i.e. each patient will take 3 tablets a day, receiving 1 active treatment and 2 placebo matching the alternative active treatments, or 3 placebos matching the alternative treatments.

  Patients will be required to attend 11 scheduled clinic visits and one telephone visit over approximately 38 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 three placebo tablets The tablets will be taken in addition to insulin.
  iv. Randomised Treatment Period (Visits 6-11): during this 26 week period, patients will receive study medication, either Empagliflozin or placebo, in addition to their insulin.
  v. Follow-Up Period (Visit 12): 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/0350

• Date of REC Opinion

  23 Oct 2015

• REC opinion

  Further Information Favourable Opinion