A Study to Test How New Long-acting Insulin (Insulin Icodec) Works in the Body of Children and Teenagers
NCT ID: NCT05790681
Last Updated: 2025-07-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
18 participants
INTERVENTIONAL
2023-04-25
2024-02-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Participants with Type 2 Diabetes
Participants will receive single subcutaneous (s.c.) fixed dose of insulin icodec (700 units per milliliter \[U/mL\]) that is 5.6 units per kilogram (U/kg) bodyweight. Subjects will be followed up for 5 weeks after dosing.
Insulin icodec
Participants will receive subcutaneously fixed dose of insulin icodec (700 U/mL) that is 5.6 U/kg bodyweight.
Interventions
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Insulin icodec
Participants will receive subcutaneously fixed dose of insulin icodec (700 U/mL) that is 5.6 U/kg bodyweight.
Eligibility Criteria
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Inclusion Criteria
* Aged 10 to less than (\<) 18 years at the time of signing informed consent
* Diagnosed with type 2 diabetes mellitus greater than or equal to (\>=) 30 days prior to the day of screening
* Glycated haemoglobin (HbA1c) less than or equal to (\<=) 10% (86 millimoles per mole \[mmol/mol\]) at screening
* Treated with basal insulin, premix insulin or continuous subcutaneous insulin infusion (CSII) with or without bolus insulin or additional anti-diabetic drug(s).
* Current daily basal insulin treatment \>= 0.2 (I) units per kilogram per day (U/kg/day) with stable doses \>=30 days prior to the day of screening
Exclusion Criteria
* Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method
10 Years
18 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Transparency dept. 2834
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Children's Hosp-Los Angeles
Los Angeles, California, United States
Children's Hospital Los Angeles - Endocrinology
Los Angeles, California, United States
Yale New Haven Hospital, Hospital Research Unit
New Haven, Connecticut, United States
Yale University
New Haven, Connecticut, United States
Nemours Children's Health
Jacksonville, Florida, United States
Nemours Chld Clnc Jacksonville
Jacksonville, Florida, United States
Pennington Biom Res Ctr
Baton Rouge, Louisiana, United States
John Hopkins Univ Hosp
Baltimore, Maryland, United States
UBMD Peds-Div of Endo/Diabetes
Buffalo, New York, United States
Cincinnati Child's Hsp Med Ctr
Cincinnati, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
University of Virginia Clinical Research Unit
Charlottesville, Virginia, United States
University of Virginia
Charlottesville, Virginia, United States
Countries
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Other Identifiers
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U1111-1271-9231
Identifier Type: OTHER
Identifier Source: secondary_id
NN1436-4888
Identifier Type: -
Identifier Source: org_study_id
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