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The objective of the trial is to assess the effect of single subcutaneous doses of dasiglucagon versus placebo on post-prandial plasma glucose nadir following a Mixed Meal Test in Roux-en-Y Gastric Bypass (RYGB) subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Experimental | Dasiglucagon high dose, followed by placebo, followed by dasiglucagon low dose |
|
| Sequence 2 | Experimental | Dasiglucagn low dose, followed by dasiglucagon high dose, followed by placebo |
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| Sequence 3 | Experimental | Placebo, followed by dasiglucagon low dose, followed by dasiglucagon high dose |
|
| Sequence 4 | Experimental | Dasiglucagon high dose, followed by dasiglucagon low dose, followed by placebo |
|
| Sequence 5 | Experimental | Placebo, followed by dasiglucagon high dose, followed by dasiglucagn low dose |
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| Sequence 6 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dasiglucagon | Drug | dasiglucagon SC, low dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Nadir plasma glucose concentration | From trial drug administration to 240 minutes after initiation of Mixed Meal Test |
| Measure | Description | Time Frame |
|---|---|---|
| Percent time spent in hypoglycemia | Defined as time with a plasma glucose value of 70 mg/dL (3.9 mmol/L) or less | From trial drug administration to 240 minutes after initiation of Mixed Meal Test |
| Percent time spent in clinical significant hypoglycemia |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D007003 | Hypoglycemia |
| D044882 | Glucose Metabolism Disorders |
| ID | Term |
|---|---|
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000710373 | dasiglucagon |
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Dasiglucagon low dose, followed by placebo, followed by dasiglucagon high dose |
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| Dasiglucagon | Drug | dasiglucagon SC, high dose |
|
| Placebo | Drug | placebo for dasiglucagon |
|
Defined as time with a plasma glucose value of 54 mg/dL (3.0 mmol/L) or less |
| From trial drug administration to 240 minutes after initiation of Mixed Meal Test |
| Percent time spent in target range | Defined as time with a plasma glucose value of 70-180 mg/dL (3.9-10.0 mmol/L) | From trial drug administration to 240 minutes after initiation of Mixed Meal Test |
| Percent time spent in hyperglycemia | Defined as time with a plasma glucose value >180 mg/dL (>10 mmol/l) | From trial drug administration to 240 minutes after initiation of Mixed Meal Test |