Pharmacokinetic Single Dose Trial of Empagliflozin in Children and Adolescents With Type 2 Diabetes Mellitus

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: empagliflozin low dose; Drug: empagliflozin medium dose; Drug: empagliflozin high dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT02121483

2013-002304-14 (EudraCT Number)

1245.87

Details and patient eligibility

About

The aim of the study is to generate pharmacokinetic and pharmacodynamic data to identify the safe-effective dose of empagliflozin in children and adolescents aged 10 to less than 18 years with type 2 diabetes mellitus.

Enrollment: 27 patients

Sex: All

Ages: 10 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children and adolescents with type 2 diabetes mellitus
• Insufficient glycaemic control (HbA1c <=10.5%) despite diet and exercise and/or metformin and/or stable basal or MDI 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

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 the screening visit 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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27 participants in 3 patient groups

empagliflozin high dose

Experimental group

Description:

Patient to receive a high dose of empagliflozin

Treatment:

Drug: empagliflozin high dose

empagliflozin medium dose

Experimental group

Description:

Patient to receive a medium dose of empagliflozin

Treatment:

Drug: empagliflozin medium dose

empagliflozin low dose

Experimental group

Description:

Patient to receive a low dose of empagliflozin

Treatment:

Drug: empagliflozin low dose