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NCT02121483 Clinical Trial

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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
An Open-label, Randomised, Multicentre, Single-dose, Parallel Group Trial to Evaluate Pharmacokinetics and Pharmacodynamics of Empagliflozin in Children and Adolescents From 10 to Less Than 18 Years of Age With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02121483
Other study ID # 1245.87
Secondary ID 2013-002304-14
Status Completed
Phase Phase 1
First received April 22, 2014
Last updated March 22, 2016
Start date June 2014
Est. completion date February 2016

Study information
Verified date March 2016
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santéIsrael: Israeli Health Ministry Pharmaceutical AdministrationMexico: Federal Commission for Sanitary Risks ProtectionSouth Africa: Medicines Control CouncilUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 27
Est. completion date February 2016
Est. primary completion date February 2016
Accepts healthy volunteers No
Gender Both
Age group 10 Years to 17 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• empagliflozin medium dose

• empagliflozin high dose

• empagliflozin low dose

Locations
Country Name City State
France 1245.87.33001 Boehringer Ingelheim Investigational Site Lyon
Israel 1245.87.97202 Boehringer Ingelheim Investigational Site Beer Sheva
Israel 1245.87.97201 Boehringer Ingelheim Investigational Site Petah-Tikva
Israel 1245.87.97203 Boehringer Ingelheim Investigational Site Tel Hashomer
Mexico 1245.87.52001 Boehringer Ingelheim Investigational Site Chihuahua
South Africa 1245.87.27003 Boehringer Ingelheim Investigational Site Bellville
South Africa 1245.87.27002 Boehringer Ingelheim Investigational Site Pretoria
United States 1245.87.01004 Boehringer Ingelheim Investigational Site Boston Massachusetts
United States 1245.87.01013 Boehringer Ingelheim Investigational Site New Haven Connecticut
United States 1245.87.01012 Boehringer Ingelheim Investigational Site Philadelphia Pennsylvania
United States 1245.87.01001 Boehringer Ingelheim Investigational Site Pittsburgh Pennsylvania
United States 1245.87.01002 Boehringer Ingelheim Investigational Site Toledo Ohio

Sponsors (2)
Lead Sponsor Collaborator
Boehringer Ingelheim Eli Lilly and Company

Countries where clinical trial is conducted

United States,  France,  Israel,  Mexico,  South Africa, 

Outcome
Type Measure Description Time frame Safety issue
Primary AUC0-infinity (Area under the plasma concentration-time curve from time zero to infinite time) up to Day 3 No
Primary AUC0-tz (Area under the plasma concentration-time curve from time zero to the the time of the last quantifiable concentration) up to Day 3 No
Primary Cmax (Maximum observed plasma concentration) up to Day 3 No
Primary tmax (Time of maximum observed plasma concentration) up to Day 3 No
Primary t1/2 (Terminal half-life in plasma) up to Day 3 No
Secondary Change from baseline in urinary glucose excretion over 24 hours after study drug intake No
Secondary Change from baseline in fasting plasma glucose (mg/dL) 24 hours after study drug intake No
Secondary Change from baseline in 8-point plasma glucose profile over 24 hours after study drug intake No
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