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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1315-5122 | Other Identifier | World Health Organization (WHO) | |
| 2024-519533-38 | Other Identifier | European Medical Agency (EMA) |
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This study is testing the effect of a new study medicine NNC0194-0499 in type 1 diabetes. The purpose of the study is to compare the effect of NNC0194-0499 on the blood sugar levels of participants with type 1 diabetes when taken in combination with semaglutide or placebo. All participants will receive standard of care insulin treatment. The study will last for about 36 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: NNC0194-0499/Placebo | Experimental | After a 2-week run-in period; participants will be randomised 1:1 to a treatment sequence with two 7-week treatment periods of once weekly subcutaneous NNC0194-0499 or placebo. Between the two treatment periods; there is a wash-out period. After the wash-out period, there will be a cross over, ensuring that all the participants receive both NNC0194-0499 and placebo. |
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| Part B: NNC0194-0499/Placebo + Semaglutide | Experimental | After the 2-week run-in phase followed by the 8-week of dose escalation period (every 4 weeks) of once weekly subcutaneous semaglutide; participants will be randomised 1:1 to a treatment sequence with two 7-week treatment periods of once weekly subcutaneous NNC0194-0499 or placebo and continued semaglutide. Between the two treatment periods; there is a wash-out period where the participant continues to receive once weekly subcutaneous semaglutide. After the wash-out period, there will be a cross over, ensuring that all the participants receive both NNC0194-0499 and placebo together with semaglutide. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0194-0499 | Drug | Participants will receive subcutaneous NNC0194-0499 once weekly. |
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| Measure | Description | Time Frame |
|---|---|---|
| Part A: Change in time in range (TIR) 3.9-10.0 mmol/L (70-80 mg/dL) | Percentage point (%-points). | From baseline (day -14 - -1) to day 36-49 / day 106-119 |
| Part B: Change in time in range (TIR) 3.9-10.0 mmol/L (70-80 mg/dL) | %-points. | From baseline (day -14 - -1) to day 92-105 / day 162-175 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in coefficient of variation (CV) of sensor glucose, total | %-points. | Part A: From baseline (day -14 - -1) to day 36-49 / day 106-119; Part B: From baseline (day -14 - -1) to day 92-105 / day 162-175 |
| Change in mean sensor glucose (SG) |
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Inclusion Criteria:
Exclusion Criteria:
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| 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 | Neuss | 41460 | Germany |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.
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| Placebo | Drug | Participants will receive placebo matched to NNC0194-0499 subcutaneously. |
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| Semaglutide | Drug | Participants will receive subcutaneous semaglutide once weekly. |
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Millimoles per liter (mmol/L).
| Part A: From baseline (day -14 - -1) to day 36-49 / day 106-119; Part B: From baseline (day -14 - -1) to day 92-105 / day 162-175 |
| Change in time above range (TAR) >10.0 mmol/L (>180 mg/dL) | %-points. | Part A: From baseline (day -14 - -1) to day 36-49 / day 106-119; Part B: From baseline (day -14 - -1) to day 92-105 / day 162-175 |
| Change in time above range (TAR) >13.9 mmol/L (>250 mg/dL) | %-points. | Part A: From baseline (day -14 - -1) to day 36-49 / day 106-119; Part B: From baseline (day -14 - -1) to day 92-105 / day 162-175 |
| Time below range (TBR) <3.9 mmol/L (70 mg/dL) | % of time. | Part A: day 36-49/ day 106-119; Part B: day 92-105/ day 162-175 |
| Time below range (TBR)<3.0 mmol/L (54 mg/dL) | % of time. | Part A: day 36-49/ day 106-119; Part B: day 92-105/ day 162-175 |
| Change in time in tight range (TITR) 3.9-7.8 mmol/L (70-140 mg/dL) | %-points. | Part A: From baseline (day -14 - -1) to day 36-49 / day 106-119; Part B: From baseline (day -14 - -1) to day 92-105 / day 162-175 |
| Change in mean total daily insulin dose per kg | Ratio to baseline. | Part A: From baseline (day -3 - -1) to day 36-49 / day 106-119; Part B: From baseline (day -3 - -1) to day 92-105 / day 162-175 |
| Change in triglycerides | Ratio to baseline. | Part A: From baseline (day 1) to day 50/ day 120; Part B: From baseline (day 1) to day 106/ day 176 |
| Number of adverse events (AEs) | Number of events. | Part A: From baseline (day 1) to day 155; Part B: From baseline (day 1) to day 211 |
| Number of severe hypoglycaemic episodes (level 3) | Number of episodes. | Part A: From baseline (day 1) to day 155; Part B: From baseline (day 1) to day 211 |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000591245 | semaglutide |
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