Phase 3
N=977
Empagliflozin as Adjunctive to Insulin Therapy Over 26 Weeks in Patients With T1DM (EASE-3)
Diabetes Mellitus, Type 1
Bottom Line
View on ClinicalTrials.gov: NCT02580591 ↗Enrolled (actual)
977
Serious AEs
6.8%
Results posted
Nov 2018
Primary outcome: Primary: Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26 for Full Analysis Set (FAS) (Observed Cases [OC]) — 0.20; -0.09; -0.25; -0.33 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
- Sep 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26 for Full Analysis Set (FAS) (Observed Cases [OC]) |
0.20; -0.09; -0.25; -0.33 | <0.0001 sig |
| PRIMARY 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)) |
0.21; -0.06; -0.23; -0.30 | <0.0001 sig |
| SECONDARY Rate Per Patient-year of Investigator-reported Symptomatic Hypoglycemic Adverse Events (AEs) With Confirmed Plasma Glucose (PG) |
6.13; 5.77; 7.37; 6.25; 6.62; 6.17 | 0.2752 |
| SECONDARY Change From Baseline in Body Weight at Week 26 |
0.21; -1.55; -2.83; -3.22 | <0.0001 sig |
| SECONDARY Change From Baseline in Total Daily Insulin Dose (TDID) at Week 26 |
-0.011; -0.060; -0.080; -0.102 | <0.0001 sig |
| SECONDARY Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 26 |
0.4; -1.7; -3.5; -3.4; 0.0; -0.4 | <0.0001 sig |
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
Eligibility Criteria
Inclusion criteria
- Signed and dated written informed consent
- Male or female patient receiving insulin for the treatment of documented diagnosis of type 1 diabetes mellitus (T1DM) > 1 year
- C-peptide value of = 0.3 and = 7.5% and = 18 years
- Body Mass Index (BMI) >= 18.5 kg/m2
- Estimated glomerular filtration rate >= 30 mL/min/1.73 m2
- Women of child-bearing potential must use highly effective methods of birth control
- Compliance with trial medication administration between 80% and 120% during placebo run-in period Further inclusion criteria apply
Exclusion criteria
- History of type 2 diabetes mellitus, 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 except subcutaneous basal and bolus insulin within last 3 months
- Occurrence of severe hypoglycaemia within last 3 months and until randomisation
- Occurence of diabetic ketoacidosis within 3 months prior to Visit 1 and until Visit 6
- Irregular sleep/wake cycle
- Acute coronary syndrome, stroke or Transient Ischaemic Attack (TIA) within last 3 months
- Severe gastroparesis
- Brittle diabetes
- Liver disease
- Eating disorders
- Treatment with anti-obesity drugs, weight-loss surgery or aggressive diet regimen
- Treatment with systemic corticosteroids
- Change in dose of thyroid hormones within last 6 weeks and until randomisation
- Cancer or treatment for cancer in the last five years
- Blood dyscrasias or any disorders causing haemolysis or unstable red blood cells
- Women who are pregnant, nursing, or who plan to become pregnant whilst in the trial
- Alcohol or drug abuse
- Intake of an investigational drug in another trial within last 30 days Further exclusion criteria apply
Data sourced from ClinicalTrials.gov (NCT02580591). 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.