EUCTR2014-001922-14-DKActive, 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 52 weeks in patients with Type 1 diabetes mellitus (EASE-2) - EASE-2
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 720
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
Investigators
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