Empagliflozin as Adjunctive to inSulin thErapy in Type 1 diabetes over 52 weeks (EASE-2)

Phase 1

Conditions: Type 1 diabetes mellitus
MedDRA version: 20.0Level: PTClassification code 10067584Term: Type 1 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders
Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

Registration Number: EUCTR2014-001922-14-DK

Lead Sponsor: Boehringer Ingelheim Danmark A/S

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 720

Inclusion Criteria

- 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
- Fasting C-peptide value of < 0.7 ng/mL (0.23 nmol/L) at Visit 2 measured by the central laboratory
- Use of, and be willing, based on the Investigator's judgement, to continue throughout the duration of the trial, either:
--MDI of insulin consisting of at least one basal insulin injection and at least three daily bolus injections OR
--CSII of any insulin type, with at least 5 months experience of using CSII prior to Visit 1
- HbA1c >/= 7.5% and - Age >/= 18 years at Visit 1

Additional inclusion criteria may 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 576
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 144

Exclusion Criteria

- History of T2DM, 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 (e.g. metformin, alpha-glucosidase inhibitors, 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
- Occurrence of severe hypoglycaemia involving coma and/or seizure that required hospitalisation or hypoglycaemia-related treatment by an emergency physician or paramedic within 3 months prior to Visit 1
- Occurence of severe DKA (i.e a pH of <7.0 or prolonged Intensive Care Unit admission exceeding two days) requiring hospitalisation within 3 months prior to Visit 1

Additional exclusion criteria may apply