Diabetes mellitus type 1 MedDRA version: 16.0 Level: PT Classification code 10067584 Term: Type 1 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Product Name: Empagliflozin
Product Code: BI 10773
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Empagliflozin
CAS Number: 864070-44-0
Other descriptive name: Empagliflozin
Concentratio
Sponsors
Boehringer Ingelheim Pharma GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Signed and dated written informed consent - Male or female patient receiving insulin for treatment of T1DM for at least 12 months - C-peptide =65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: - Acute symptomatic urinary tract infection or genital infection, chronic or recurrent cystitis - 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 - Type 1 diabetes mellitus treatment with any other antihyperglycaemic drug except insulin within last 3 months or history of clinically relevant hypersensitivity - Occurrence of hypoglycaemia that required hospitalization or treatment by an emergency physician or paramedic within last 3 months - Hypoglycaemia unawareness or frequent episodes of unexplained hypoglycaemia - Occurrence of diabetic ketoacidosis that required hospitalization or treatment by an emergency physician or paramedic within last 12 months - History of macrovascular disease including cardiovascular, cerebrovascular and peripheral artery disease - Autonomic neuropathy with gastroparesis - Brittle diabetes - Liver disease - Treatment with anti-obesity drugs, surgery or aggressive diet regimen leading to unstable body weight - Treatment with systemic corticosteroids - Change in dose of thyroid hormones within last 6 weeks or planned change or initiation of such a therapy - Medical history of cancer or treatment for cancer in the last five years - Blood dyscrasias or any disorders causing haemolysis or unstable red blood cells - Alcohol or drug abuse that would interfere with trial participation or any ongoing clinical condition that would jeopardize patient's or site personnel's safety or study compliance - Intake of an investigational drug in another trial within last 30 days - Not able to understand and comply with study requirements - Pre-menopausal women who are nursing or pregnant or of child-bearing potential and are not practising an acceptable method of birth control
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Impact of empagliflozin on 24 h urinary glucose excretion (UGE) after seven days of administration compared to placebo and add-on to a stable insulin background therapy in patients with T1DM;Secondary Objective: Safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of once daily oral empagliflozin in patients with type 1 diabetes mellitus (T1DM) as adjunctive therapy to insulin. An objective of the second treatment period (Day 8 to 28), when the patient¿s background insulin administration algorithm should be adjusted to achieve optimal glycaemic control, is to gain experience on the need for such adjustments and to allow for adjustment recommendations in subsequent trials;Primary end point(s): 1: Change from baseline in 24 h UGE (g/24 h) after seven days of treatment with empagliflozin 2.5 mg, 10 mg, or 25 mg, or placebo ;Timepoint(s) of evaluation of this end point: 1: 7 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Austria, Germany
Contacts
Public ContactQRPE PSC CT Information Disclosure
Boehringer Ingelheim Pharma GmbH & Co. KG
Outcome results
None listed