A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of Insulin Icodec in Subjects With Type 2 Diabetes
NCT ID: NCT04582435
Last Updated: 2023-09-18
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
46 participants
INTERVENTIONAL
2020-10-16
2022-04-22
Brief Summary
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Participants will get insulin degludec as well as insulin icodec - Insulin icodec is a new medicine while insulin degludec is commonly used and prescribed by doctors.
Participants will administer subcutaneous injections of insulin degludec once daily for at least one week (7 injections) but this period may be extended up to 8 weeks. Thereafter, once weekly subcutaneous injections of insulin icodec will follow, resulting in a total of at least 8 but not more than 16 subcutaneous injections of icodec.
The study will last for about 17-32 weeks Participants will have at least 5 in-house visits (where participants will stay at the clinic) and 17 outpatient visits with the study doctor.
Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.
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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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Insulin icodec
Participants will receive individualised weekly doses of insulin icodec
Insulin Icodec
Participants will receive 1 dose from a prefilled pen, administered subcutaneously (under the skin), once a week by designated study staff, for a total of at least 8 and a maximum of 16 doses which equals 8-16 weeks of treatment.
Interventions
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Insulin Icodec
Participants will receive 1 dose from a prefilled pen, administered subcutaneously (under the skin), once a week by designated study staff, for a total of at least 8 and a maximum of 16 doses which equals 8-16 weeks of treatment.
Eligibility Criteria
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Inclusion Criteria
* Aged 18-75 years (both inclusive) at the time of signing informed consent
* Body mass index between 18.0 and 38.0 kg/m\^2 (both inclusive)
* HbA1c (glycated haemoglobin) below or equal to 9 percentage (75 mmol/mol) at screening
* Current daily basal insulin treatment greater than or equal to 0.2 (I)U/kg/day with or without any of the following anti-diabetic drugs/regimens with stable doses greater than or equal to 90 days prior to the day of screening: 1) Any metformin formulation 2) Other oral antidiabetic drugs: DPP-4 nhibitors / SGLT2 inhibitors / Oral combination products (for the allowed individual oral antidiabetic drugs)
* Oral or injectable GLP-1 Receptor Agonists
Exclusion Criteria
* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method
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. 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Graz, , Austria
Countries
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References
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Pieber TR, Asong M, Fluhr G, Holler V, Kristensen NR, Larsen JH, Ribel-Madsen R, Svehlikova E, Vinther S, Voortman M, Haahr H. Pharmacokinetic and pharmacodynamic properties of once-weekly insulin icodec in individuals with type 2 diabetes. Diabetes Obes Metab. 2023 Dec;25(12):3716-3723. doi: 10.1111/dom.15266. Epub 2023 Sep 11.
Other Identifiers
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U1111-1244-4346
Identifier Type: OTHER
Identifier Source: secondary_id
2019-004606-10
Identifier Type: REGISTRY
Identifier Source: secondary_id
NN1436-4569
Identifier Type: -
Identifier Source: org_study_id
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