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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-004529-34 | EudraCT Number | ||
| U1111-1204-8972 | Other Identifier | World Health Organization |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with normal renal function | Experimental | Participants with normal renal function (glomerular filtration rate [GFR] of greater than or equal to 90 ml/min) will receive single dose of insulin 287 on Day 1. |
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| Participants with mildly decreased renal function | Experimental | Participants with mildly decreased renal function (GFR of 60 to less than 90 ml/min) will receive single dose of insulin 287 on Day 1. |
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| Participants with moderately decreased renal function | Experimental | Participants with moderately decreased renal function (GFR of 30 to less than 60 ml/min) will receive single dose of insulin 287 on Day 1. |
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| Participants with severely decreased renal function | Experimental | Participants with severely decreased renal function (GFR of less than 30 not requiring dialysis) will receive single dose of insulin 287 on Day 1. |
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| Participants with end-stage renal disease | Experimental | Participants with end-stage renal disease requiring haemodialysis will receive single dose of insulin 287 on Day 1. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin icodec | Drug | Participants will receive single dose of Insulin 287 subcutaneously (under the skin) on Day 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUCI287,0-840h,SD: Area under the serum insulin 287 concentration-time curve after a single dose | Measured in pmol*h/L | From 0 to 840 hours after trial product administration (visit 2 (study day 1)) |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax,I287,SD: Maximum observed serum insulin 287 concentration after a single dose | Measured in pmol/L | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Reporting Anchor and Disclosure (1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité Research Organisation GmbH | Berlin | 10117 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38722461 | Result | Haahr H, Cieslarova B, Hingst JR, Jiang S, Kristensen NR, Kupcova V, Norgreen L, Wagner FH, Ignatenko S. The Effect of Various Degrees of Renal or Hepatic Impairment on the Pharmacokinetic Properties of Once-Weekly Insulin Icodec. Clin Pharmacokinet. 2024 Jun;63(6):819-830. doi: 10.1007/s40262-024-01375-2. Epub 2024 May 9. |
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According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000712207 | insulin icodec |
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|
Measured in hours |
| From 0 to tz hours after trial product administration (visit 2 (study day 1)). |
| Number of adverse events | Number of events | 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) | From visit 2 (study day 1, pre-dose) to visit 13 (study day 43) |
| Change in anti-insulin 287 antibody titres | Number of dilutions | 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 | At visit 13 (study day 43) |
| D004700 | Endocrine System Diseases |