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".
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
58
Participants will receive single dose of Insulin 287 subcutaneously (under the skin) on Day 1
Charité Research Organisation GmbH
Berlin, Germany
AUCI287,0-840h,SD: Area under the serum insulin 287 concentration-time curve after a single dose
Measured in pmol\*h/L
Time frame: From 0 to 840 hours after trial product administration (visit 2 (study day 1))
Cmax,I287,SD: Maximum observed serum insulin 287 concentration after a single dose
Measured in pmol/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
tmax,I287,SD: Time to maximum observed serum insulin 287 concentration after a single dose
Measured in hours
Time frame: From 0 to tz hours after trial product administration (visit 2 (study day 1)).
Number of adverse events
Number of events
Time frame: From trial product administration (visit 2 (study day 1)) until visit 13 (study day 43)
Change in anti-insulin 287 antibody level
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)
Change in anti-insulin 287 antibody titres
Number of dilutions
Time frame: From visit 2 (study day 1, pre-dose) to visit 13 (study day 43)
Positive cross-reactive anti-human insulin antibodies
Number of patients with/without positive cross-reactive anti-human insulin antibodies
Time frame: At visit 13 (study day 43)
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