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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1314-8868 | Other Identifier | World Health Organization (WHO) | |
| 2024-519382-22 | 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 study is conducted to see if the new medicine can lower high sugar levels in the blood. 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 partici-pants in this study: healthy participants and participants with type 2 diabetes. Participant will either get study medicine (NNC9733-0001) or placebo (a treatment that has no active medicine in it). Which treatment the participant gets is decided by chance. Which dose (strength) the participant get is determined by when participant enter the study. Participant will get one dose which will be injected into the area around abdomen (belly) by the medical staff. The number of injections (up to 4 injections) will depend on the group the participant is assigned to. Larger doses require multiple injections. The study will last for about 40 weeks (10 months).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NNC9733-0001 | Experimental | Participants will be administered a single dose of NNC9733-0001 in a dose escalated manner. |
|
| Placebo | Experimental | Participants will be administered a single dose of matching NNC9733-0001 placebo in a dose escalated manner. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC9733-0001 | Drug | Administered a single dose of NNC9733-0001. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of treatment emergent adverse events (TEAEs) | Measured as number of events | From dosing (day 1) until end of study (EOS) visit (week 36) |
| Number of hypoglycaemic events | Measured as number of events | From dosing (day 1) until end of study (EOS) visit (week 36) |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-last: The area under the NNC9733-0001 plasma concentration-time curve from time zero to last measurable concentration after a single dose | Measured in hours × nanogram/millilitre (ng/mL) | From dosing (day 1) to 48 hours after dosing |
| Cmax: The maximum concentration of NNC9733-0001 in plasma |
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Inclusion Criteria:
All participants
Healthy participants
Participants with T2DM
Exclusion Criteria:
Healthy participants
Participants with T2DM - Any disorder, except for mild conditions under stable treatment associated with T2DM, which in the investigator's opinion might jeopardise participant safety or compliance with the protocol.
• Supine blood pressure at screening outside the range of 90-159 mmHg for systolic or 50-99 mmHg for diastolic. This exclusion criterion also pertains to those participants who are receiving antihypertensive treatment.
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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 |
|---|---|
| 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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| Placebo |
| Drug |
Administered a single dose of matching NNC9733-0001 placebo. |
|
Measured in nanogram/millilitre (ng/mL) |
| From dosing (day 1) to 48 hours after dosing |
| tmax: The time from dose administration to maximum plasma concentration of NNC9733-0001 | Measured in hours | From dosing (day 1) to 48 hours after dosing |
| t1/2: Terminal half-life for NNC9733-0001 after a single dose | Measured in hours | From dosing (day 1) to 48 hours after dosing |
| D004700 | Endocrine System Diseases |