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

• Conditions: Type 2 diabetes mellitus; MedDRA version: 17.0Level: 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-Outside-EU/EEA
• Lead Sponsor: Boehringer Ingelheim Pharmaceuticals (Pty) Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05-06
• Last Update Posted: 12 May 2014

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

- Children and adolescents with type 2 diabetes mellitus
- Insufficient glycaemic control (6.5% < HbA1c > 10.5%) despite diet and exercise and/or metformin
- 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
- Current insulin therapy or having received insulin within 4 weeks before randomisation
- Treatment with weight reduction medications within 4 weeks before randomisation

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified