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)
Overview
- Phase
- Phase 3
- Intervention
- Empagliflozin
- Conditions
- Diabetes Mellitus, Type 1
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 977
- Locations
- 189
- Primary Endpoint
- Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26 for Full Analysis Set (FAS) (Observed Cases [OC])
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The study will investigate the efficacy, safety, tolerability and Pharmacokinetic(PK) of 3 doses of empagliflozin compared with placebo over 26 weeks in 960 patients with type 1 diabetes mellitus as adjunctive therapy to insulin
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Empagliflozin high dose
Intervention: Empagliflozin
Empagliflozin low dose
Intervention: Empagliflozin
Empagliflozin low dose
Intervention: Placebo
Empagliflozin high dose
Intervention: Placebo
Empagliflozin medium dose
Intervention: Empagliflozin
Empagliflozin medium dose
Intervention: Placebo
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26 for Full Analysis Set (FAS) (Observed Cases [OC])
Time Frame: Baseline to week 26
Change from baseline in Glycated hemoglobin (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 randomized trial medication. Least squares mean is adjusted mean change from baseline.
Change From Baseline in Glycated Hemoglobin (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 hemoglobin (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 randomized trial medication. Least squares mean is adjusted mean change from baseline.
Secondary Outcomes
- Rate Per Patient-year of Investigator-reported Symptomatic Hypoglycemic Adverse Events (AEs) With Confirmed Plasma Glucose (PG)(Week 5 to Week 26, Week 1 to Week 26)
- Change From Baseline in Body Weight at Week 26(Baseline to week 26)
- Change From Baseline in Total Daily Insulin Dose (TDID) at Week 26(Baseline to week 26)
- Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 26(Baseline to week 26)