Clinical trial NCT02121483: Pharmacokinetic Single Dose Trial of Empagliflozin in Children and Adolescents With Type 2 Diabetes Mellitus
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2014-04-23
Enrollment: 27
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: AUC0-inf
timeFrame: Before drug administration (-0:30 hours (h)) and 0:30h, 1:00h, 1:30h, 2:00h, 4:00h, 8:00h, 12:00 (Day 1), 24:00 (Day 2), 34:00 (Day 2), 48:00 (Day 3) after drug administration.
measure: AUC0-tz
timeFrame: Before drug administration (-0:30 hours (h)) and 0:30h, 1:00h, 1:30h, 2:00h, 4:00h, 8:00h, 12:00 (Day 1), 24:00 (Day 2), 34:00 (Day 2), 48:00 (Day 3) after drug administration.
measure: Cmax
timeFrame: Before drug administration (-0:30 hours (h)) and 0:30h, 1:00h, 1:30h, 2:00h, 4:00h, 8:00h, 12:00 (Day 1), 24:00 (Day 2), 34:00 (Day 2), 48:00 (Day 3) after drug administration.
measure: Tmax
timeFrame: Before drug administration (-0:30 hours (h)) and 0:30h, 1:00h, 1:30h, 2:00h, 4:00h, 8:00h, 12:00 (Day 1), 24:00 (Day 2), 34:00 (Day 2), 48:00 (Day 3) after drug administration.
measure: t1/2
timeFrame: Before drug administration (-0:30 hours (h)) and 0:30h, 1:00h, 1:30h, 2:00h, 4:00h, 8:00h, 12:00 (Day 1), 24:00 (Day 2), 34:00 (Day 2), 48:00 (Day 3) after drug administration.
Secondary outcomes:
measure: Change From Baseline in Urinary Glucose Excretion (UGE) Over 24 h After Study Drug Intake
timeFrame: baseline and 24 hours
measure: Change From Baseline in Fasting Plasma Glucose (FPG) at 24 h After Study Drug Intake
timeFrame: baseline and 24 hours
measure: Change From Baseline in 8-point Plasma Glucose Profile Over 24 h After Study Drug Intake
timeFrame: baseline and 24 hours
Other outcomes:
Locations:
city: New Haven
country: United States
facility: 1245.87.01013 Boehringer Ingelheim Investigational Site
state: Connecticut
city: Boston
country: United States
facility: 1245.87.01004 Boehringer Ingelheim Investigational Site
state: Massachusetts
city: Toledo
country: United States
facility: 1245.87.01002 Boehringer Ingelheim Investigational Site
state: Ohio
city: Philadelphia
country: United States
facility: 1245.87.01012 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: 1245.87.01001 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Lyon
country: France
facility: 1245.87.33001 Boehringer Ingelheim Investigational Site
city: Beer Sheva
country: Israel
facility: 1245.87.97202 Boehringer Ingelheim Investigational Site
city: Tel Hashomer
country: Israel
facility: 1245.87.97203 Boehringer Ingelheim Investigational Site
city: Chihuahua
country: Mexico
facility: 1245.87.52001 Boehringer Ingelheim Investigational Site
city: Bellville
country: South Africa
facility: 1245.87.27003 Boehringer Ingelheim Investigational Site
city: Pretoria
country: South Africa
facility: 1245.87.27002 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: Bjornstad P, Laffel L, Tamborlane WV, Simons G, Hantel S, von Eynatten M, George J, Marquard J, Cherney DZI. Acute Effect of Empagliflozin on Fractional Excretion of Sodium and eGFR in Youth With Type 2 Diabetes. Diabetes Care. 2018 Aug;41(8):e129-e130. doi: 10.2337/dc18-0394. Epub 2018 Jun 25. No abstract available.
citation: Laffel LMB, Tamborlane WV, Yver A, Simons G, Wu J, Nock V, Hobson D, Hughan KS, Kaspers S, Marquard J. Pharmacokinetic and pharmacodynamic profile of the sodium-glucose co-transporter-2 inhibitor empagliflozin in young people with Type 2 diabetes: a randomized trial. Diabet Med. 2018 Aug;35(8):1096-1104. doi: 10.1111/dme.13629. Epub 2018 May 6.