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)
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)
Comparison of 2 doses of empagliflozin vs placebo in patients already using either an insulin regimen of multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII). Randomisation to 3 treatments arms (equal assignment) following a screening period, an optimisation period and a run-in period. 52 week double-blind treatment period, and 3 week follow-up period.
Inclusion criteria:
Male or female patient receiving insulin for the treatment of documented diagnosis of Type 1 Diabetes Mellitus (T1DM) for at least 1 year at the time of Visit 1
Fasting C-peptide value of < 0.7 ng/mL (0.23 nmol/L) at Visit 2 measured by the central laboratory
Use of, and be willing, based on the Investigator's judgement, to continue throughout the duration of the trial, either:
HbA1c >/= 7.5% and </= 10.0% at Visit 5 measured by the central laboratory
Age >/= 18 years at Visit 1
Additional inclusion criteria may apply
Exclusion criteria:
Additional exclusion criteria may apply
Cincinnati, Ohio 45219, United States
Saint Ingbert/Oberwürzbach, 66386, Germany
Lørenskog, N-1478, Norway
Buckinghamshire, MK65LD, United Kingdom
Surrey, RH1 5RH, United Kingdom