Type 1 diabetes mellitus MedDRA version: 19.1 Level: PT Classification code 10067584 Term: Type 1 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: Jardiance
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Empagliflozin
CAS Number: 864070-44-0
Current Sponsor
Sponsors
Boehringer Ingelheim Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed and dated written informed consent by the date of Visit 1 in accordance with Good Clinical Practice (GCP) and local legislation 2. Male or female patient receiving insulin for the treatment of documented diagnosis of T1DM for at least 1 year at the time of Visit 1 3. Fasting C-peptide value of 0.5% between Visit 1 and Visit 5 6. Based on the Investigator's judgement patient must have a good understanding of his/her disease and how to manage it, and be willing and capable of performing the following study assessments (assessed at Visits 1-5 and just before randomisation): - patient-led management and adjustment of insulin therapy - reliable approach to insulin dose adjustment for meals, such as carbohydrate counting - reliable and regular home-based blood glucose monitoring - recognise the symptoms of DKA, and reliably monitor for ketones - implementation of an established "sick day" management regimen 7. Age = 18 years at Visit 1 8. Body Mass Index (BMI) of = 18.5 kg/m2 at Visit 1 9. eGFR = 30 mL/min/1.73 m² as calculated by the CKD-EPI formula, based on creatinine measured by the central laboratory at Visit 1 10. Women of child-bearing potential* must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. Such methods should be used throughout the study and the patient must agree to periodic pregnancy testing during participation in the trial. A list of contraceptive methods meeting these criteria will be provided in the patient information *Women of child-bearing potential are defined as follows: Any female who has experienced menarche and is not post-menopausal (defined as at least 12 months with no menses without an alternative medical cause) or who is not permanently sterilised (e.g. hysterectomy, bilateral oophorectomy or bilateral salpingectomy) 11. Compliance with trial medication administration must be between 80% and 120% during the open-label placebo run-in period (see Section 4.1.8.1 for calculation of compliance), to be judged before randomisation Additional inclusion criteria may apply Are the trial subjects under 18? no
Exclusion criteria
Exclusion criteria: 1. History of T2DM, maturity onset diabetes of the young (MODY), pancreatic surgery or chronic pancreatitis 2. Pancreas, pancreatic islet cells or renal transplant recipient 3. T1DM treatment with any other antihyperglycaemic drug (e.g. metformin, alphaglucosidase inhibitors, glucagon-like-peptide 1 (GLP-1) analogues, SGLT-2 inhibitors, pramlintide, inhaled insulin, pre-mixed insulins etc.) except subcutaneous basal and bolus insulin within 3 months prior to Visit 1 or any history of clinically relevant hypersensitivity according to Investigator's judgement 4. Occurrence of severe hypoglycaemia involving coma/unconsciousness and/or seizure that required hospitalisation or hypoglycaemia-related treatment by an emergency physician or paramedic within 3 months prior to Visit 1 and until randomisation 5. Occurrence of DKA within 3 months prior to Visit 1 and until randomisation 6. Irregular sleep/wake cycle (e.g. patients who habitually sleep during the day and work during the night) based on Investigator's judgement 7. Acute coronary syndrome (non-STEMI, STEMI and unstable angina pectoris), stroke or transient ischaemic attack (TIA) within 3 months prior to Visit 1 8. Diagnosis of severe gastroparesis (based on Investigator's judgement) 9. Diagnosis of brittle diabetes based on Investigator judgement 10. Indication of liver disease, defined by serum levels of either alanine transaminase (ALT), aspartate transaminase (AST), or alkaline phosphatase above 3 x upper limit of normal (ULN) at Visit 1 or Visit 5 as measured by the central laboratory 11. Eating disorders such as bulimia or anorexia nervosa 12. Treatment with anti-obesity drugs, weight-loss surgery or aggressive diet regimen leading to unstable body weight (based on Investigator's judgement) 3 months prior to Visit 1 and until randomisation 13. Treatment with systemic corticosteroids or planned initiation of such therapy at Visit 1 and until randomisation. Inhaled or topical use of corticosteroids (e.g. for asthma/chronic obstructive pulmonary disease) is acceptable 14. Change in dose of thyroid hormones within 6 weeks prior to Visit 1 or planned change or initiation of such a therapy at Visit 1 and until randomisation 15. Patient is unwilling, based on the Investigator's judgement, to avoid use of paracetamol (acetaminophen) containing drugs throughout the CGM monitoring periods, since this may falsely raise CGM glucose readings 16. Medical history of cancer or treatment for cancer in the last five years prior to Visit 1. Resected basal cell carcinoma considered cured is exempted 17. Blood dyscrasias or any disorders causing haemolysis or unstable red blood cells (e.g. malaria, babesiosis, haemolytic anaemia) at Visit 1 18. Women who are pregnant, nursing, or who plan to become pregnant whilst in the trial 19. Al
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of empagliflozin in patients with T1DM as adjunctive to insulin therapy;Secondary Objective: To assess the safety and tolerability of empagliflozin in patients with T1DM as adjunctive to insulin therapy; 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: Incidence rate of symptomatic hypoglycaemic AEs with confirmed plasma glucose 70 to = 180 mg/dL (> 3.9 to = 10.0 mmol/L) as determined by continuous glucose monitoring (CGM) 5: Change from baseline in the inter quartile range (IQR) as determined by CGM 6: Change from baseline in total daily insulin dose (TDID), U/kg 7: Change from baseline in systolic blood pressure (SBP) 8: Change from baseline in diastolic blood pressure (DBP) ; Timepoint(s) of evaluation of this end point: 1: weeks 5 to 26 2: weeks 1 to 26 3: 26 weeks 4: weeks 23 to 26 5: weeks 23 to 26 6: 26 weeks 7: 26 weeks 8: 26 weeks | — |
Countries
Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Netherlands, Norway, Poland, Spain, Sweden, Taiwan, United Kingdom, United States
Contacts
Public ContactQRPE PSC CT Information Disclosure
Boehringer Ingelheim Pharma GmbH & Co. KG
Outcome results
None listed