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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-004993-68 | EudraCT Number |
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The primary aim of the study is to evaluate the glucose response to low-dose glucagon (single 150 µg dose) administered immediately before aerobic exercise in individuals with AHCL-treated T1D.
The study consists of a screening visit (visit A) and two additional study visits (visit B and visit C) completed in a sequential order. During study visit B participants will receive s.c. administration of 150 ug glucagon prior to a 45-min moderate intensity continuous exercise session and subsequently continue into a 1-hour post-exercise observation period. During study visit C the exact same procedures will be followed with the omission of glucagon.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 150 ug glucagon before exercise | Experimental | 150 ug glucagon will be administered subcutaneously just before exercise |
|
| Control | No Intervention | No glucagon will be administered before exercise |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GlucaGen | Drug | 150 ug glucagon will be administered to the participants before exercise. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Percentage of Time in Target Glucose Range (PG: 3.9 - 10.0 mmol/l) During and for 1-hour After Dynamic Physical Exercise Between Visit B and C | This outcome measure evaluates the difference in the percentage of time participants spend within a specified glucose target range over a defined monitoring period. The measure aims to assess improvements or changes in glycemic control resulting from the intervention under study. | 0 min to +105 min |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Incidence Rate of Hypoglycaemic Events (PG<3.9 mmol/l) Between Visit B and C | This outcome measure assesses the frequency of hypoglycemic events experienced by participants over a specified monitoring period. | 0 min to +105 min |
| Difference in Time (Min) to Hypoglycaemia (PG<3.9 mmol/l) Between Visit B and C |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sissel B Lundemose, MD | Steno Diabetes Center Copenhagen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Steno Diabetes Center Copenhagen | Herlev | 2730 | Denmark |
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This is a cross-over study. A total of 10 unique participants were enrolled and assigned to both arms sequentially. Therefore, the number of participants started in each arm is 10, but these represent the same individuals.
We initially planned for 16 participants, but only 10 participants completed both visits.
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| ID | Title | Description |
|---|---|---|
| FG000 | 150 ug Glucagon Before Exercise | 150 ug glucagon will be administered subcutaneously just before exercise GlucaGen: 150 ug glucagon will be administered to the participants before exercise. |
| FG001 | Control | No glucagon will be administered before exercise |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Visit B |
| |||||||||||||
| Visit C |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 150 µg Glucagon Before Exercise Then No Glucagon Administered Before Exercise | All participants received 150 µg Glucagon before exercise during Visit B, followed by a control condition (no glucagon) during Visit C in a fixed sequence |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Difference in Percentage of Time in Target Glucose Range (PG: 3.9 - 10.0 mmol/l) During and for 1-hour After Dynamic Physical Exercise Between Visit B and C | This outcome measure evaluates the difference in the percentage of time participants spend within a specified glucose target range over a defined monitoring period. The measure aims to assess improvements or changes in glycemic control resulting from the intervention under study. | Posted | Median | Full Range | Percentage of time in range | 0 min to +105 min |
|
Fromtime 0 until time 105, the entire trial.
Visuel analouge scale (VAS) score 1-100
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 150 ug Glucagon Before Exercise | 150 ug glucagon will be administered subcutaneously just before exercise GlucaGen: 150 ug glucagon will be administered to the participants before exercise. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr | Steno Diabetes Center Copenhagen | +45 39 68 08 00 | SDC-FP-Stenoinfo@regionh.dk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 13, 2023 | Mar 17, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D007003 | Hypoglycemia |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D005934 | Glucagon |
| ID | Term |
|---|---|
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
| D006728 | Hormones |
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Two-arm open-label intervention study.
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This outcome measure evaluates the time (in minutes) taken to reach hypoglycemia during a specified monitoring period or following a specific intervention. |
| 0 min to +105 min |
| Difference in Percentage of Time Below Target Glucose Range (PG<3.9 mmol/l) Between Visit B and C | This outcome measure evaluates the difference in the percentage of time participants spend within a specified glucose target range over a defined monitoring period. The measure aims to assess improvements or changes in glycemic control resulting from the intervention under study. | 0 min to +105 min |
| Difference in Percentage of Time Above Target Glucose Range (PG>10.0 mmol/l) Between Visit B and C | This outcome measure evaluates the difference in the percentage of time participants spend within a specified glucose target range over a defined monitoring period. The measure aims to assess improvements or changes in glycemic control resulting from the intervention under study. | 0 min to +105 min |
| Difference in Incidence Rate of Hyperglycaemia (PG>10.0 mmol/l) Between Visit B and C | This outcome measure assesses the incidence rate of hyperglycemia during a specified monitoring period. | 0 min to +105 min |
| Difference in Nadir PG Concentration Between Visit B and C | This outcome measure assesses the difference in the lowest value of plasma glucose during a specified monitoring period. | 0 min to +105 min |
| Difference in Peak PG Concentration Between Visit B and C | This outcome measure assesses the difference in peak plasma glucose during a specified monitoring period. | 0 min to +105 min |
| Difference in Incremental Peak PG Concentration Between Visit B and C | This outcome measure assesses the difference in incremental peak of plasma glucose during a specified monitoring period. | 0 min to +105 min |
| Difference in Mean PG Concentration Between Visit B and C | This outcome measure assesses the difference in mean plasma glucose during a specified monitoring period. | 0 min to +105 min |
| Difference in PG Area Under the Curve (AUC) Between Visit B and C | This outcome measure assesses the difference in plasma glucose AUC during a specified monitoring period. | 0 min to +105 min |
| Difference in Standard Deviation in PG Concentrations Between Visit B and C | This outcome measure assesses the difference in SD plasma glucose during a specified monitoring period. | 0 min to +105 min |
| Difference in Coefficient of Variation in PG Concentrations Between Visit B and C | This outcome measure assesses the difference in CV in plasma glucose during a specified monitoring period. | 0 min to +105 min |
| NOT COMPLETED |
|
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
No glucagon will be administered before exercise
|
|
| Secondary | Difference in Incidence Rate of Hypoglycaemic Events (PG<3.9 mmol/l) Between Visit B and C | This outcome measure assesses the frequency of hypoglycemic events experienced by participants over a specified monitoring period. | Posted | Count of Participants | Participants | 0 min to +105 min |
|
|
|
| Secondary | Difference in Time (Min) to Hypoglycaemia (PG<3.9 mmol/l) Between Visit B and C | This outcome measure evaluates the time (in minutes) taken to reach hypoglycemia during a specified monitoring period or following a specific intervention. | Posted | Median | Full Range | minutes | 0 min to +105 min |
|
|
|
| Secondary | Difference in Percentage of Time Below Target Glucose Range (PG<3.9 mmol/l) Between Visit B and C | This outcome measure evaluates the difference in the percentage of time participants spend within a specified glucose target range over a defined monitoring period. The measure aims to assess improvements or changes in glycemic control resulting from the intervention under study. | Posted | Median | Full Range | percentage of time below range | 0 min to +105 min |
|
|
|
| Secondary | Difference in Percentage of Time Above Target Glucose Range (PG>10.0 mmol/l) Between Visit B and C | This outcome measure evaluates the difference in the percentage of time participants spend within a specified glucose target range over a defined monitoring period. The measure aims to assess improvements or changes in glycemic control resulting from the intervention under study. | Posted | Median | Full Range | percentage of time above range | 0 min to +105 min |
|
|
|
| Secondary | Difference in Incidence Rate of Hyperglycaemia (PG>10.0 mmol/l) Between Visit B and C | This outcome measure assesses the incidence rate of hyperglycemia during a specified monitoring period. | Posted | Number | participants | 0 min to +105 min |
|
|
|
| Secondary | Difference in Nadir PG Concentration Between Visit B and C | This outcome measure assesses the difference in the lowest value of plasma glucose during a specified monitoring period. | Posted | Median | Full Range | mmol/l | 0 min to +105 min |
|
|
|
| Secondary | Difference in Peak PG Concentration Between Visit B and C | This outcome measure assesses the difference in peak plasma glucose during a specified monitoring period. | Posted | Mean | Standard Deviation | mmol/l | 0 min to +105 min |
|
|
|
| Secondary | Difference in Incremental Peak PG Concentration Between Visit B and C | This outcome measure assesses the difference in incremental peak of plasma glucose during a specified monitoring period. | Posted | Median | Full Range | mmol/l | 0 min to +105 min |
|
|
|
| Secondary | Difference in Mean PG Concentration Between Visit B and C | This outcome measure assesses the difference in mean plasma glucose during a specified monitoring period. | Posted | Mean | Standard Error | mmol/l | 0 min to +105 min |
|
|
|
| Secondary | Difference in PG Area Under the Curve (AUC) Between Visit B and C | This outcome measure assesses the difference in plasma glucose AUC during a specified monitoring period. | Posted | Median | Full Range | mmol/l*min | 0 min to +105 min |
|
|
|
| Secondary | Difference in Standard Deviation in PG Concentrations Between Visit B and C | This outcome measure assesses the difference in SD plasma glucose during a specified monitoring period. | Posted | Median | Full Range | mmol/l | 0 min to +105 min |
|
|
|
| Secondary | Difference in Coefficient of Variation in PG Concentrations Between Visit B and C | This outcome measure assesses the difference in CV in plasma glucose during a specified monitoring period. | Posted | Mean | Standard Deviation | Percentage of variation | 0 min to +105 min |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Control | No glucagon will be administered before exercise | 0 | 10 | 0 | 10 | 0 | 10 |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001519 | Behavior |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |