Empagliflozin as Adjunctive to InSulin thErapy Over 52 Weeks in Patients With Type 1 Diabetes Mellitus (EASE-2)
- Registration Number
- NCT02414958
- Lead Sponsor
- Boehringer Ingelheim
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 730
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Empagliflozin low dose Empagliflozin Empagliflozin tablets once daily Placebo Placebo Placebo tablets matching empagliflozin once daily Empagliflozin high dose Empagliflozin Empagliflozin tablets once daily
- Primary Outcome Measures
Name Time Method Change From Baseline in Glycated Haemoglobin (HbA1c) at Week 26 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) ) 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 Outcome Measures
Name Time Method 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 interstitial glucose variability based on the IQR as determined by CGM is presented for week 23 to 26. Least squares mean is actually an adjusted event rate.
Change From Baseline in Total Daily Insulin Dose (TDID) at Week 26 Baseline to week 26 Change from baseline in TDID 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.
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 the percentage of time spent in target glucose range of \>70 to ≤180 mg/dL (\>3.9 to ≤10.0 mmol/L) as determined by continuous glucose monitoring (CGM) is presented in week 23 to 26. Least squares mean is actually an adjusted event rate.
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 This is a key secondary endpoint. Rate per patient-year of investigator-reported symptomatic hypoglycaemia adverse events (AEs) with confirmed plasma glucose (PG) \<54 milligram per deciliter (mg/dL) (\<3.0 millimoles per litre (mmol/L)) and/or severe hypoglycaemia AEs (i.e. all investigator-reported AEs that had confirmed PG \<54 mg/dL \[\<3.0 mmol/L\] with symptoms reported and all severe hypoglycaemia 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.
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 randomised 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 SBP and DBP 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.
Trial Locations
- Locations (131)
AMCR Institute, Inc.
🇺🇸Escondido, California, United States
Diabetes/Lipid Management and Research Center
🇺🇸Huntington Beach, California, United States
National Research Institute
🇺🇸Los Angeles, California, United States
Mills-Peninsula Health Services
🇺🇸San Mateo, California, United States
Metabolic Institute of America
🇺🇸Tarzana, California, United States
University Clinical Investigators, Inc.
🇺🇸Tustin, California, United States
Creekside Endocrine Associates, PC
🇺🇸Denver, Colorado, United States
The Center for Diabetes and Endocrine Care
🇺🇸Fort Lauderdale, Florida, United States
East Coast Institute for Research, LLC
🇺🇸Jacksonville, Florida, United States
Baptist Diabetes Associates, PA
🇺🇸Miami, Florida, United States
Scroll for more (121 remaining)AMCR Institute, Inc.🇺🇸Escondido, California, United States