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

• Status: Completed
• Trial end date: 2017-09-20
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Collaborator: Eli Lilly and Company
• Treatments: Empagliflozin

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 < 0.7 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