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| ID | Type | Description | Link |
|---|---|---|---|
| H-21000002 | Other Identifier | Regional Scientific Ethics Committee | |
| 2020-005745-16 | EudraCT Number |
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The aim of the study is to evaluate the efficacy, safety and feasibility of outpatient-utilization of low-dose dasiglucagon administered via a multi-dose reusable pen injector in preventing and treating mild hypoglycemia in insulin pump-treated people with type 1 diabetes.
A randomized, open-label, two-arm, two-week crossover study will be conducted to assess the study objectives. The study will enroll 24 participants with insulin pump-treated type 1 diabetes. Upon study enrollment, participants will complete two consecutive 2-week periods - a 'usual care' period and 'dasiglucagon' period. During the 'usual care' period, participants will manage episodes of manifest or impending hypoglycemia as usual, e.g. through carbohydrate consumption or manual insulin pump suspension. During the 'dasiglucagon' period, participants will use pen-administered low-dose dasiglucagon to treat or prevent episodes of hypoglycemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care | No Intervention | During the 'usual care' period, participants will manage episodes of manifest or impending hypoglycemia as usual, e.g. through carbohydrate consumption or manual insulin pump suspension. | |
| Dasiglucagon | Experimental | During the 'dasiglucagon' period, participants will use pen-administered low-dose (80 µg) dasiglucagon to treat or prevent episodes of hypoglycemia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dasiglucagon | Drug | Abdominal s.c. administration using a multi-dose reusable pen injector |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in percentage of time in range between the two study periods | Sensor glucose level ≥ 3.9 mmol/l and ≤ 10.0 mmol/l | 2-week 'usual care' period and 2-week 'dasiglucagon' period |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in percentage of time in hypoglycemia between the two study periods | Sensor glucose level < 3.9 mmol/l | 2-week 'usual care' period and 2-week 'dasiglucagon' period |
| Difference in percentage of time in hyperglycemia between the two study periods |
| Measure | Description | Time Frame |
|---|---|---|
| Number of device failures/malfunctions | 2-week 'dasiglucagon' period |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christian Laugesen, MD | Steno Diabetes Center Copenhagen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Steno Diabetes Center Copenhagen | Gentofte Municipality | 2820 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37037948 | Derived | Laugesen C, Ranjan AG, Schmidt S, Norgaard K. Pen-administered low-dose dasiglucagon vs usual care for prevention and treatment of non-severe hypoglycaemia in people with type 1 diabetes during free-living conditions: a Phase II, randomised, open-label, two-period crossover trial. Diabetologia. 2023 Jul;66(7):1208-1217. doi: 10.1007/s00125-023-05909-4. Epub 2023 Apr 11. |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D007003 | Hypoglycemia |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000710373 | dasiglucagon |
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A Randomized, Open-Label, Two-Period, Two-Week Crossover Outpatient Study
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Open Label
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Sensor glucose level > 10 mmol/l |
| 2-week 'usual care' period and 2-week 'dasiglucagon' period |
| Difference in coefficient of variation (%) between the two study periods | 2-week 'usual care' period and 2-week 'dasiglucagon' period |
| Difference between successful cases (%) of hypoglycemia treatment between the two study periods | Initial sensor glucose level ≥ 2.2 mmol/l and ≤ 3.9 mmol/l AND sensor glucose level > 3.9 mmol/l 30 minutes post-treatment | 2-week 'usual care' period and 2-week 'dasiglucagon' period |
| Difference in successful cases (%) of hypoglycemia treatment without subsequent hyperglycemia [sensor glucose level > 10 mmol/l during the first two hours post-treatment] between the two study periods | Initial sensor glucose level ≥ 2.2 mmol/l and ≤ 3.9 mmol/l AND sensor glucose level > 3.9 mmol/l 30 minutes post-treatment AND sensor glucose level ≤ 10 mmol/l during the first two hours post-treatment | 2-week 'usual care' period and 2-week 'dasiglucagon' period |
| Difference in successful cases (%) of hypoglycemia prevention between the two study periods | Initial sensor glucose level > 3.9 mmol/l AND sensor glucose level < 3.9 for ≤ 15 consecutive minutes during the first two hours post-treatment | 2-week 'usual care' period and 2-week 'dasiglucagon' period |
| Difference in time from hypoglycemia treatment to euglycemia between the two study periods | Minutes from initial sensor glucose level ≥ 2.2 mmol/l and ≤ 3.9 mmol/l to sensor glucose level ≥ 3.9 mmol/l | 2-week 'usual care' period and 2-week 'dasiglucagon' period |
| Incidence rate of supplement carbohydrate administration during the first hour following dasiglucagon administration | 2-week 'dasiglucagon' period |
| Difference between the average daily carbohydrate intake between the two study periods | Registered on the insulin pump | 2-week 'usual care' period and 2-week 'dasiglucagon' period |
| Difference between the average total daily insulin dose between the two study periods | 2-week 'usual care' period and 2-week 'dasiglucagon' period |
| Difference in the number and intensity of episodes with nausea, headache, stomach-ache, palpitations and injection site pain between the two study periods | Intensity: mild/moderate/severe | 2-week 'usual care' period and 2-week 'dasiglucagon' period |
| Percentage of participants scoring a favorable outcome on the patient-reported outcome questionnaire | Scoring likely OR very likely on a four-point Likert scale | At the end-of-study visit (estimated week 6) |
| Percentage of participants with treatment-induced or treatment-boosted anti-dasiglucagon antibodies | Measured 4 weeks after the 'dasiglucagon' period |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |