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

Completed · Phase 1

Conditions studied: Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT02121483

Run by

Boehringer Ingelheim

People needed

27

Starts

2014-06-01

Expected to finish

2016-02-01

Last updated by the study team

2016-09-19

Who can join

Age: 10 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 1245.87.01013 Boehringer Ingelheim Investigational Site — New Haven, Connecticut, United States
• 1245.87.01004 Boehringer Ingelheim Investigational Site — Boston, Massachusetts, United States
• 1245.87.01002 Boehringer Ingelheim Investigational Site — Toledo, Ohio, United States
• 1245.87.01012 Boehringer Ingelheim Investigational Site — Philadelphia, Pennsylvania, United States
• 1245.87.01001 Boehringer Ingelheim Investigational Site — Pittsburgh, Pennsylvania, United States
• 1245.87.33001 Boehringer Ingelheim Investigational Site — Lyon, France
• 1245.87.97202 Boehringer Ingelheim Investigational Site — Beersheba, Israel
• 1245.87.97203 Boehringer Ingelheim Investigational Site — Tel Litwinsky, Israel
• 1245.87.52001 Boehringer Ingelheim Investigational Site — Chihuahua City, Mexico
• 1245.87.27003 Boehringer Ingelheim Investigational Site — Bellville, South Africa
• 1245.87.27002 Boehringer Ingelheim Investigational Site — Pretoria, South Africa

Full record on ClinicalTrials.gov

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