Empagliflozin as Adjunctive to Insulin Therapy Over 26 Weeks in Patients With T1DM (EASE-3)

Boehringer Ingelheim

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 1

Treatments: Drug: Placebo; Drug: Empagliflozin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02580591

2014-005256-26 (EudraCT Number)

1245.72

Details and patient eligibility

About

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

Enrollment: 977 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 < 0.7 ng/mL
• Use of Multiple Daily Injections (MDI) of insulin or insulin pump user with total daily insulin >= 0.3 and <= 1.5 U/kg
• Glycated haemoglobin (HbA1c) >= 7.5% and <= 10.0%
• Good understanding of T1DM
• Age >= 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

977 participants in 4 patient groups, including a placebo group

Empagliflozin low dose

Experimental group

Treatment:

Drug: Placebo

Drug: Empagliflozin

Empagliflozin high dose

Experimental group

Treatment:

Drug: Placebo

Drug: Empagliflozin

Empagliflozin medium dose

Experimental group

Treatment:

Drug: Placebo

Drug: Empagliflozin

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo