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)
Overview
- Phase
- Phase 3
- Intervention
- Empagliflozin
- Conditions
- Diabetes Mellitus, Type 1
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 730
- Locations
- 131
- Primary Endpoint
- Change From Baseline in Glycated Haemoglobin (HbA1c) at Week 26
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Empagliflozin low dose
Empagliflozin tablets once daily
Intervention: Empagliflozin
Empagliflozin high dose
Empagliflozin tablets once daily
Intervention: Empagliflozin
Placebo
Placebo tablets matching empagliflozin once daily
Intervention: Placebo
Outcomes
Primary Outcomes
Change From Baseline in Glycated Haemoglobin (HbA1c) at Week 26
Time Frame: Baseline to week 26
Change from baseline in glycated haemoglobin (HbA1c) for full analysis set (FAS) (observed cases \[OC\]) is presented. With regards to efficacy and safety endpoints, the term 'baseline' referred to the last observed measurement prior to administration of any randomised trial medication. Least squares mean is adjusted mean change from baseline. Restricted maximum likelihood estimation based on mixed-effect model for repeated measures (MMRM) analysis was used to obtain adjusted means for the treatment effects.
Change From Baseline in Glycated Haemoglobin (HbA1c) at Week 26 for Modified Intention-to-treat Population Set (mITT) (Observed Case (OC) - All Data (AD) (OC-AD) )
Time Frame: Baseline to week 26
Change from baseline in glycated haemoglobin (HbA1c) for modified intention-to-treat population set (mITT) (observed case - all data \[OC-AD\]) is presented. With regards to efficacy and safety endpoints, the term 'baseline' referred to the last observed measurement prior to administration of any randomised trial medication. Least squares mean is adjusted mean change from baseline. Restricted maximum likelihood estimation based on mixed-effect model for repeated measures (MMRM) analysis was used to obtain adjusted means for the treatment effects.
Secondary Outcomes
- Change From Baseline in Interstitial Glucose Variability Based on the Interquartile Range (IQR) as Determined by CGM in Weeks 23 to 26(Week 23 to 26)
- Change From Baseline in Total Daily Insulin Dose (TDID) at Week 26(Baseline to week 26)
- Change From Baseline in Percentage of Time Spent in Target Glucose Range From Weeks 23 to 26(Week 23 to 26)
- Change From Baseline in Body Weight at Week 26(Baseline to week 26)
- Rate Per Patient-year of Investigator-reported Symptomatic Hypoglycaemia Adverse Events (AEs) With Confirmed Plasma Glucose (PG)(Week 5 to Week 26, Week 1 to Week 26)
- Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 26(Baseline to week 26)