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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1329-6912 | Other Identifier | World Health Organization (WHO) | |
| 2025-523304-68 | Other Identifier | European Medical Agency (EMA) |
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This study is testing a new medicine that might help treat people with type 2 diabetes. The purpose of the study is to see if the new study medicine is safe and how well is tolerated by the body. There will be two groups of participants in this study: healthy participants and participants with type 2 diabetes. Participant will either get study medicine (NNC1679-0001) or placebo (a treatment that has no active medicine in it). NNC1679-0001 is a new experimental medicine that doctors cannot prescribe yet. Which treatment the participant gets is decided by chance. Participant will get one dose which will be injected into the area around abdomen (belly) by the medical staff.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NNC1679-0001 | Experimental | Participants will receive NNC1679-0001 subcutaneously. |
|
| Placebo | Placebo Comparator | Participants will receive placebo matched to NNC1679-0001 s.c. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC1679-0001 | Drug | NNC1679-0001 will be administered subcutaneously. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Treatment-Emergency Adverse Events (TEAEs) | Measured in events. | From dosing (day 1) upto week 34 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of TEAEs | Measured in events. | From dosing (day 1) until V15a/V15b (week 26) |
| Number of hypoglycaemic episodes | Measured in episodes. |
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Inclusion Criteria:
All participants
Healthy participants
Participants with Type 2 Diabetes Mellitus (T2DM)
Exclusion Criteria:
All participants
Healthy participants
Participants with T2DM
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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 |
|---|---|---|---|---|---|---|
| Medical University of Graz | Recruiting | Graz | 8010 | Austria |
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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Sponsor staff involved in the clinical trial is masked according to company standard procedures.
| Placebo |
| Drug |
Placebo will be administered subcutaneously. |
|
| From dosing (day 1) upto week 34 |
| AUC: The area under the NNC1679-0001 plasma concentration-time curve from time zero to the last measurable concentration after a single dose | Measured in hours*nanograms per milliliter (hour × ng/mL). | From dosing (day 1) upto day 3 or day 15 |
| Cmax: The maximum concentration of NNC1679-0001 in plasma after a single dose | Measured in nanograms per milliliter (ng/mL). | From dosing (day 1) upto day 3 or day 15 |
| tmax: The time from dosing to maximum plasma concentration of NNC1679-0001 after a single dose | Measured in hours. | From dosing (day 1) upto day 3 or day 15 |
| t1/2: Terminal half-life for NNC1679-0001 after a single dose | Measured in hours. | From dosing (day 1) upto day 3 or day 15 |
| CLR: Renal clearance of NNC1679-0001 after a single dose | Measured in liter per hours (L/hours). | From dosing (day 1) upto day 3 |
| D004700 | Endocrine System Diseases |