Empagliflozin as adjunctive to insulin therapy over 26 weeks in patients with T1DM (EASE-3)

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) - EASE-3

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-005256-26-SE

Enrollment

1920

Registered

2015-08-20

Start date

2015-09-10

Completion date

Unknown

Last updated

2018-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with confirmed, insulin-dependent type 1 diabetes mellitus for at least a year MedDRA version: 19.0 Level: LLT Classification code 10012608 Term: Diabetes mellitus insulin-dependent System Organ Class: 100000004861

Interventions

Product Name: Empagliflozin Product Code: BI 10773 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Empagliflozin CAS Number: 864070-44-0 Current Sponsor code: BI 10773 Other descriptive n

Eligibility

Sex/Gender

All

Inclusion 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 Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 860 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100

Exclusion criteria

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 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

Design outcomes

Primary

Measure	Time frame
Main Objective: Efficacy of once daily oral doses of empagliflozin in patients with T1DM as adjunctive therapy to insulin;Secondary Objective: Safety, tolerability and PK of empagliflozin in patients with T1DM as adjunctive therapy to insulin;Primary end point(s): 1: Change from baseline in HbA1c ;Timepoint(s) of evaluation of this end point: 1: 26 weeks	—

Secondary

Measure	Time frame
Secondary end point(s): 1: Change from baseline in body weight 2: Change from baseline in total daily insulin dose 3: Incidence rate of symptomatic hypoglycaemic AEs with confirmed plasma glucose < 54 mg/dL (< 3.0 mmol/L) and/or severe hypoglycaemic AEs per patient-year 4: Incidence rate of symptomatic hypoglycaemic AEs with confirmed plasma glucose < 54 mg/dL (< 3.0 mmol/L) and/or severe hypoglycaemic AEs per patient-year 5: Change from baseline in systolic blood pressure (SBP) 6: Change from baseline in diastolic blood pressure (SBP);Timepoint(s) of evaluation of this end point: 1: 26 weeks 2: 26 weeks 3: Week 5 to Week 26 4: Week 1 to Week 26 5: 26 weeks 6: 26 weeks	—

Measure

Time frame

Secondary end point(s): 1: Change from baseline in body weight 2: Change from baseline in total daily insulin dose 3: Incidence rate of symptomatic hypoglycaemic AEs with confirmed plasma glucose < 54 mg/dL (< 3.0 mmol/L) and/or severe hypoglycaemic AEs per patient-year 4: Incidence rate of symptomatic hypoglycaemic AEs with confirmed plasma glucose < 54 mg/dL (< 3.0 mmol/L) and/or severe hypoglycaemic AEs per patient-year 5: Change from baseline in systolic blood pressure (SBP) 6: Change from baseline in diastolic blood pressure (SBP);Timepoint(s) of evaluation of this end point: 1: 26 weeks 2: 26 weeks 3: Week 5 to Week 26 4: Week 1 to Week 26 5: 26 weeks 6: 26 weeks

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Countries

Australia, Canada, Czech Republic, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Russian Federation, South Africa, Spain, Sweden, United Kingdom, United States

Contacts

Public ContactQRPE PSC CT Information Disclosure

Boehringer Ingelheim Pharma GmBH

clintriage.rgd@boehringer-ingelheim.com18002430127

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026