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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-001342-34 | EudraCT Number |
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The primary aim of the study is to compare the efficacy of single-administration low-dose glucagon and split-administration low-dose glucagon to placebo for prevention of exercise-induced hypoglycemia in people with type 1 diabetes using insulin pumps and multiple daily injections (MDI).
The secondary aim is to compare the accuracy of three continuous glucose monitors (CGM) during and after exercise in inpatient and outpatient settings.
A randomized, single-blinded, placebo-controlled three-arm cross-over study will be conducted to assess the study objectives. 22 participants with type 1 diabetes will complete three study visits in random order. At every visit the participants will exercise for 60 min receiving different low doses of glucagon before or before and after exercise compared with placebo.
During the visits and in an outpatient period the participants will have 3 different CGM devices installed and the values will be compared with self-monitored blood glucose values.
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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 and placebo will be administered after exercise. |
|
| 2*75 ug glucagon before exercise and after exercise | Experimental | 75 ug glucagon will be administered subcutaneously just before exercise and another 75 ug of glucagon will be administered immediately after exercise. |
|
| Saline as placebo | Active Comparator | Saline as placebo will be administered in the same amount as glucagon before and after exercise. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GlucaGen | Drug | 150 ug or 75*2 ug glucagon will be administered subcutaneously to the participants before and after exercise. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence rate of hypoglycemia (PG < 3.9 mmol/l) | From 0-180 minutes post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of time below range (PG < 3.9) | From 0-180 minutes post-intervention | |
| Percentage of time in range (PG ≥ 3.9 mmol/l and ≤ 10.0 mmol/l) | From 0-180 minutes post-intervention | |
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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 |
|---|---|---|---|---|---|---|
| Sissel Banner Lundemose | Gentofte Municipality | 2820 | Denmark |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 28, 2025 | |
| Reset | Apr 16, 2025 | |
| Release | Aug 28, 2025 | |
| Reset | Sep 16, 2025 | |
| Release | Jun 8, 2026 | |
| Reset | Jul 2, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 28, 2025 | Apr 16, 2025 | |||
| Aug 28, 2025 |
| 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 |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
| D006728 | Hormones |
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A randomized, single-blinded, placebo-controlled three-arm cross-over study
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Single-blinded
|
| Saline | Drug | Saline will be used as placebo before and after exercise. |
|
|
| Time (min) to hypoglycemia (PG < 3.9 mmol/l) |
| From 0-180 minutes post-intervention |
| Change in plasma glucose levels | From 0-180 minutes post-intervention |
| Incidence rate of hyperglycemia (PG > 10 mmol/l) | From 0-180 minutes post-intervention |
| Nadir plasma glucose concentration | From 0-180 minutes post-intervention |
| Peak plasma glucose concentration | From 0-180 minutes post-intervention |
| Incremental peak in plasma glucose concentration | From 0-180 minutes post-intervention |
| Mean plasma glucose concentration | From 0-180 minutes post-intervention |
| Plasma glucose Area Under the Curve (AUC) | From 0 to 180 min post-intervention |
| Percentage of time in hyperglycemia (PG > 10 mmol/l) | From 0-180 minutes post-intervention |
| Change in visual analogue scale (VAS) for nausea, headache, stomachache, injection site pain and palpitations from intervention (tintervention = 0) to 180 min post-intervention | From 0-180 minutes post-intervention |
| Mean absolute relative difference (MARD) during the 60-minutes exercise session (using SMBG as the reference value) | During exercise |
| MARD during the three-day outpatient period (using the 5 daily SMBG as the reference value) | During the three-day outpatient period |
| MARD during the three-hour inpatient study visit (using YSI as reference value) | During exercise |
| Rate-of change (ROC) accuracy (using SMBG and YSI as the reference value) | During exercise and during the three-day outpatient period |
| Point accuracy with the Clarke Error Grid Analysis (CEGA) (using SMBG and YSI as the reference value) | During exercise and during the three-day outpatient period |
| Sep 16, 2025 |
| Jun 8, 2026 | Jul 2, 2026 |
| 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 |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |