EUCTR2014-005256-26-HUActive, not recruitingPhase 1
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
Boehringer Ingelheim RCV GmbH & Co KG0 sites1,920 target enrollmentStarted: September 28, 2015Last updated:
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 1,920
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
- •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
- •-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
Investigators
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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)Diabetes Mellitus Type 110018424DiabetesNL-OMON44650Boehringer Ingelheim25