Empagliflozin as Adjunctive to Insulin Therapy Over 26 Weeks in Patients With T1DM (EASE-3)
- Registration Number
- NCT02580591
- Lead Sponsor
- Boehringer Ingelheim
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 977
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Empagliflozin low dose Placebo - Empagliflozin high dose Empagliflozin - Empagliflozin high dose Placebo - Empagliflozin medium dose Empagliflozin - Empagliflozin medium dose Placebo - Placebo Placebo - Empagliflozin low dose Empagliflozin -
- Primary Outcome Measures
Name Time Method Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26 for Full Analysis Set (FAS) (Observed Cases [OC]) 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)) 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 Outcome Measures
Name Time Method 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 Rate per patient-year of investigator-reported symptomatic hypoglycemic adverse events (AEs) with confirmed plasma glucose (PG) \<54 milligram per deciliter (mg/dL) (\<3.0 millimoles per litre (mmol/L)) and/or severe hypoglycemic AEs (i.e. all investigator-reported AEs that had confirmed PG \<54 mg/dL \[\<3.0 mmol/L\] with symptoms reported and all severe hypoglycemic events that were confirmed by adjudication) is presented for (i) From week 5 to 26 and (ii) From week 1 to 26. Least squares mean is actually an adjusted event rate. This is key secondary endpoints.
Change From Baseline in Body Weight at Week 26 Baseline to week 26 Change from baseline in body weight 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 Total Daily Insulin Dose (TDID) at Week 26 Baseline to week 26 Change from baseline in Total daily insulin dose (TDID) 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 Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 26 Baseline to week 26 Change from baseline in Systolic blood pressure (SBP) and Diastolic blood pressure (DBP) 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.
Trial Locations
- Locations (189)
Healthscan Clinical Trials LLC
🇺🇸Montgomery, Alabama, United States
John Muir Physician Network Clinical Research Center
🇺🇸Concord, California, United States
Valley Research
🇺🇸Fresno, California, United States
Marin Endocrine Care and Research
🇺🇸Greenbrae, California, United States
Pacific Research Partners, LLC
🇺🇸Oakland, California, United States
NorCal Endocrinology and Internal Medicine
🇺🇸San Ramon, California, United States
William Sansum Diabetes Center
🇺🇸Santa Barbara, California, United States
University of Colorado Denver
🇺🇸Aurora, Colorado, United States
International Research Associates, LLC
🇺🇸Hialeah, Florida, United States
Solutions Through Advanced Research, Inc.
🇺🇸Jacksonville, Florida, United States
Scroll for more (179 remaining)Healthscan Clinical Trials LLC🇺🇸Montgomery, Alabama, United States