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)
- Conditions
- DiabetesDiabetes Mellitus Type 110018424
- Registration Number
- NL-OMON44650
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 25
- Signed and dated written informed consent
- Male or female patient receiving insulin for the treatment of documented diagnosis of type 1 diabetes mellitus (T1DM) for at least 1 year
- C-peptide value of < 0.7 ng/mL (0.23 nmol/L) at visit 2
- 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 (eGFR) * 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, see protocol section 3.3.2.
- 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 prior to Visit 1 and until Visit 6
- 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 at Visit 1 and until Visit 6
- Change in dose of thyroid hormones within last 6 weeks to Visit 1 and until Visit 6
- 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, see protocol section 3.3.3.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoint is the change from baseline in HbA1c after 26 weeks.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- incidence rate of symptomatic hypoglycaemic adverse events (AEs) with<br /><br>confirmed plasma glucose < 54 mg/dL (< 3.0 mmol/L) and/or severe<br /><br>hypoglycaemic AEs per patient-year from Week 5 to Week 26<br /><br>- incidence rate of symptomatic hypoglycaemic AEs with confirmed plasma glucose<br /><br>< 54 mg/dL (< 3.0 mmol/L) and/or severe hypoglycaemic AEs per patient-year from<br /><br>Week 1 to Week 26<br /><br>- change from baseline in body weight (kg) after 26 weeks<br /><br>- change from baseline in total daily insulin dose (TDID), U/kg, after 26 weeks<br /><br>- change from baseline in systolic blood pressure (SBP) after 26 weeks<br /><br>- change from baseline in diastolic blood pressure (DBP) after 26 weeks</p><br>