Phase 3
N=730
Empagliflozin as Adjunctive to InSulin thErapy Over 52 Weeks in Patients With Type 1 Diabetes Mellitus (EASE-2)
Diabetes Mellitus, Type 1
Bottom Line
View on ClinicalTrials.gov: NCT02414958 ↗Enrolled (actual)
730
Serious AEs
13.3%
Results posted
Nov 2018
Primary outcome: Primary: Change From Baseline in Glycated Haemoglobin (HbA1c) at Week 26 — 0.09; -0.44; -0.44 Percentage (%) — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Empagliflozin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Apr 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Glycated Haemoglobin (HbA1c) at Week 26 |
0.09; -0.44; -0.44 | <0.0001 sig |
| PRIMARY 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) ) |
0.09; -0.43; -0.42 | <0.0001 sig |
| SECONDARY Rate Per Patient-year of Investigator-reported Symptomatic Hypoglycaemia Adverse Events (AEs) With Confirmed Plasma Glucose (PG) |
8.92; 6.64; 6.48; 9.13; 7.07; 7.15 | 0.0623 |
| SECONDARY Change From Baseline in Body Weight at Week 26 |
-0.10; -2.79; -3.37 | <0.0001 sig |
| SECONDARY Change From Baseline in Percentage of Time Spent in Target Glucose Range From Weeks 23 to 26 |
-1.13; 10.73; 11.74 | <0.0001 sig |
| SECONDARY Change From Baseline in Interstitial Glucose Variability Based on the Interquartile Range (IQR) as Determined by CGM in Weeks 23 to 26 |
1.62; -15.30; -17.41 | <0.0001 sig |
| SECONDARY Change From Baseline in Total Daily Insulin Dose (TDID) at Week 26 |
-0.010; -0.102; -0.100 | <0.0001 sig |
| SECONDARY Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 26 |
-0.8; -2.9; -4.5; -0.3; -1.6; -2.6 | 0.0397 sig |
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.
Eligibility Criteria
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 /= 7.5% and /= 18 years at Visit 1
Additional inclusion criteria may apply
Exclusion criteria
- History of Type 2 Diabetes Mellitus (T2DM), maturity onset diabetes of the young (MODY), pancreatic surgery or chronic pancreatitis
- Pancreas, pancreatic islet cells or renal transplant recipient
- T1DM treatment with any other antihyperglycaemic drug (e.g. metformin, alpha-glucosidase inhibitors, Glucagon-like-peptide 1 (GLP-1) analogues, Sodium-Glucose Co-Transporter (SGLT-2) inhibitors, pramlintide, inhaled insulin, pre-mixed insulins etc.) except subcutaneous basal and bolus insulin within 3 months prior to Visit 1
- Occurrence of severe hypoglycaemia involving coma/unconsciousness and/or seizure that required hospitalisation or hypoglycaemia-related treatment by an emergency physician or paramedic within 3 months prior to Visit 1 and until randomisation
- Occurence of Diabetic Ketoacidosis (DKA) within 3 months prior to Visit 1 and until randomisation
Additional exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT02414958). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.