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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1320-4780 | Other Identifier | World Health Organization (WHO) | |
| 2025-521595-55 | Other Identifier | European Medical Agency (EMA) |
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The purpose of this clinical study is to find out how NNC0487-0111 affects, how the body uses insulin (a hormone that helps the body control blood sugar) and how well the pancreas works in people living with type 2 diabetes. There are 2 study treatments. Participants will get either NNC0487-0111 (the treatment being tested) or Placebo (a treatment that has no active medicine in it). Which treatment participants get is decided by chance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NNC0487-0111 dose level 1 | Experimental | Participants will be randomized to receive NNC0487-0111 dose level 1 subcutaneously once weekly. |
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| NNC0487-0111 dose level 2 | Experimental | Participants will be randomized to receive NNC0487-0111 dose level 2 subcutaneously once weekly. |
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| NNC0487-0111 dose level 3 | Experimental | Participants will be randomized to receive NNC0487-0111 dose level 3 subcutaneously once weekly. |
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| Placebo | Placebo Comparator | Participants will receive placebo matched to NNC0487-0111 subcutaneously once weekly. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0487-0111 | Drug | NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors to the abdomen. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in M-value in Hyperinsulinaemic euglycaemic clamp (HEC) | Measured as milligram per minute per kilogram (mg/min/kg) | Baseline to week 40 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in M-value in HEC, normalised by lean body mass | Measured as mg/min/kg | Baseline to week 40 |
| Change in first-phase incremental Insulin Secretion Rate (ISR0-8 min) in Hyperglycaemic clamp (HGC) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Novo Nordisk | Contact | (+1) 866-867-7178 | clinicaltrials@novonordisk.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Profil Institut für Stoffwechselforschung GmbH | Recruiting | Neuss | 41460 | Germany |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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Sponsor staff involved in the clinical trial is masked according to company standard procedures
| Placebo | Drug | Placebo matched to NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors to the abdomen. |
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Measured as picomole per minute per meter square (pmol/min/m^2)
| Baseline to week 40 |
| Change in second-phase ISR (ISR20-120 min) in HGC | Measured as pmol/min/m^2 | Baseline to week 40 |
| Change in total ISR (ISR0-120 min) in HGC | Measured as pmol/min/m^2 | Baseline to week 40 |
| Change in ISR at fixed glucose concentration (ISRg) in HGC | Measured as pmol/min/m^2 | Baseline to week 40 |
| Change in total insulin response [total area under curve (AUC0-120) min] in HGC | Measured as picomole per liter per minute (min*pmol/L) | Baseline to week 40 |
| Change in clamp disposition index (cDI) calculated from HEC and HGC | Measured as picomole per liter per meter square per minute square per kilogram (pmol*L/m^2/min^2/kg) | Baseline to week 40 |
| Change in cDI calculated from HEC and HGC, based on lean body mass | Measured as pmol*L/m^2/min^2/kg | Baseline to week 40 |
| Change in β-cell glucose sensitivity (insulin secretion) from HGC | Measured as picomole per minute per meter square per millimoles per liter [pmol/min/m^2/ (mmol/L)] | Baseline to week 40 |
| Change in β-cell glucose sensitivity from mixed meal tolerance test (MMTT) (slope of dose-response for insulin secretion vs. plasma glucose) | Measured as pmol/min/m^2/ (mmol/L) | Baseline to week 40 |
| Change in glycated haemoglobin (HbA1c) | Measured as percentage (%) of HbA1c | Baseline to week 40 |