Pharmacokinetic Single Dose Trial of Empagliflozin in Children and Adolescents With Type 2 Diabetes Mellitus
NCT ID: NCT02121483
Last Updated: 2016-09-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
27 participants
INTERVENTIONAL
2014-06-30
2016-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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empagliflozin high dose
Patient to receive a high dose of empagliflozin
empagliflozin high dose
empagliflozin medium dose
Patient to receive a medium dose of empagliflozin
empagliflozin medium dose
empagliflozin low dose
Patient to receive a low dose of empagliflozin
empagliflozin low dose
Interventions
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empagliflozin medium dose
empagliflozin high dose
empagliflozin low dose
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
10 Years
17 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Boehringer Ingelheim
INDUSTRY
Responsible Party
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Principal Investigators
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Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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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
Countries
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References
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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.
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.
Other Identifiers
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2013-002304-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1245.87
Identifier Type: -
Identifier Source: org_study_id
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