Charité Research Organisation GmbH
Berlin, 10117, Germany
NCT Number: NCT03723785
This study will be conducted to look at the effect of decreased kidney function when getting one dose of insulin 287 and to guide dosing recommendations in people who have altered kidney function. Insulin 287 works in the body for a long time (long-acting). It is taken once a day by injecting under the skin. The main target patient group for insulin 287 is people with type 2 diabetes. Participants will get just one injection. The study will last for up to 80 days. Participants will have 11 out-patient visits with the study doctor and one in-house visit of 3 days and 2 nights. Participants will have some assessments like several blood draws, electrocardiograms (ECGs), urine collections and capillary blood sugar tests. Participants cannot take part if they are hypersensitive to the study medicine, if they received any investigational product within 90 days before screening, or if they have certain diseases e.g. HIV or hepatitis or heart problems. Participants have to take photos if they experience any allergic reactions and send them to their study doctor. Participants' kidney function will be examined by a so called "Iohexol test".
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Notify Me18 year–75 year
All sexes
Interventional
Phase 1
Berlin, 10117, Germany
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will receive single dose of Insulin 287 subcutaneously (under the skin) on Day 1
Other names: Insulin 287
Time frame: From 0 to 840 hours after trial product administration (visit 2 (study day 1))
Measured in pmol*h/L
Time frame: From 0 to tz hours after trial product administration (visit 2 (study day 1)), where tz is the time of the last quantifiable concentration
Measured in pmol/L
Time frame: From 0 to tz hours after trial product administration (visit 2 (study day 1)).
Measured in hours
Time frame: From trial product administration (visit 2 (study day 1)) until visit 13 (study day 43)
Number of events
Time frame: From visit 2 (study day 1, pre-dose) to visit 13 (study day 43)
Measured in % B/T (percentage of bound tracer measured after precipitation to total tracer)
Time frame: From visit 2 (study day 1, pre-dose) to visit 13 (study day 43)
Number of dilutions
Time frame: At visit 13 (study day 43)
Number of patients with/without positive cross-reactive anti-human insulin antibodies
Novo Nordisk A/S
Industry
Investigation of Pharmacokinetics and Safety Profile of a Single Dose NNC0148-0287 C (Insulin 287) in Subjects With Various Degrees of Renal Impairment
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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