Pharmacokinetic single dose trial of empagliflozin in children and adolescents with type 2 diabetes mellitus

Phase 1

Conditions: Type 2 diabetes mellitus
MedDRA version: 18.0Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Registration Number: EUCTR2013-002304-14-AT

Lead Sponsor: Boehringer Ingelheim RCV GesmbH + CoKG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

- Children and adolescents with type 2 diabetes mellitus
- Insufficient glycaemic control (HbA1c = 10.5%) despite diet and exercise and/or stable metformin and/or stable basal insulin
- Negative for Islet Cell Antigen and Glutamic Acid Decarboxylase autoantibodies and fasting C-peptide levels = 0.85 ng/ml
- BMI > 50th percentile for age and sex
Are the trial subjects under 18? yes
Number of subjects for this age range: 27
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Uncontrolled hyperglycaemia with a glucose level > 240 mg/dl (> 13.3 mmol/l)
- History of acute metabolic decompensation such as diabetic ketoacidosis within 3 months before screening with the exception of acute de-compensation at the time of type 2 diabetes diagnosis
- Treatment with weight reduction medications within 4 weeks before randomisation
- Current short-acting insulin or having received short-acting insulin for more than 3 days within 12 weeks prior to randomisation

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the pharmacokinetics of a single dose of empagliflozin in children and adolescents with type 2 diabetes mellitus;Secondary Objective: To assess the pharmcodynamics of a single dose of empagliflozin in the same population;Primary end point(s): 1: AUC0-infinity (Area under the plasma concentration-time curve from time zero to infinite time)<br><br>2: AUC0-tz (Area under the plasma concentration-time curve from time zero to the the time of the last quantifiable concentration)<br><br>3: Cmax (Maximum observed plasma concentration)<br><br>4: tmax (Time of maximum observed plasma concentration)<br><br>5: t1/2 (Terminal half-life in plasma)<br>;Timepoint(s) of evaluation of this end point: 1: up to Day 3<br><br>2: up to Day 3<br><br>3: up to Day 3<br><br>4: up to Day 3<br><br>5: up to Day 3<br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1: Change from baseline in urinary glucose excretion<br><br>2: Change from baseline in fasting plasma glucose (mg/dL)<br><br>3: Change from baseline in 8-point plasma glucose profile<br>;Timepoint(s) of evaluation of this end point: 1: over 24 hours after study drug intake<br><br>2: 24 hours after study drug intake<br><br>3: over 24 hours after study drug intake<br>