Ignite Creation Date:
2025-12-24 @ 3:44 PM
Ignite Modification Date:
2026-02-25 @ 8:49 PM
Study NCT ID:
NCT05076292
Status:
COMPLETED
Last Update Posted:
2023-12-05
First Post:
2021-09-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low-dose Glucagon for Prevention of Exercise-Induced Hypoglycemia in People With Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-04-16', 'releaseDate': '2025-03-28'}, {'resetDate': '2025-09-16', 'releaseDate': '2025-08-28'}], 'estimatedResultsFirstSubmitDate': '2025-03-28'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D007003', 'term': 'Hypoglycemia'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D052216', 'term': 'Glucagon-Like Peptide 1'}, {'id': 'D005934', 'term': 'Glucagon'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D004763', 'term': 'Glucagon-Like Peptides'}, {'id': 'D052336', 'term': 'Proglucagon'}, {'id': 'D005768', 'term': 'Gastrointestinal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Single-blinded'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'A randomized, single-blinded, placebo-controlled three-arm cross-over study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-08-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-04', 'studyFirstSubmitDate': '2021-09-29', 'studyFirstSubmitQcDate': '2021-10-12', 'lastUpdatePostDateStruct': {'date': '2023-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence rate of hypoglycemia (PG < 3.9 mmol/l)', 'timeFrame': 'From 0-180 minutes post-intervention'}], 'secondaryOutcomes': [{'measure': 'Percentage of time below range (PG < 3.9)', 'timeFrame': 'From 0-180 minutes post-intervention'}, {'measure': 'Percentage of time in range (PG ≥ 3.9 mmol/l and ≤ 10.0 mmol/l)', 'timeFrame': 'From 0-180 minutes post-intervention'}, {'measure': 'Time (min) to hypoglycemia (PG < 3.9 mmol/l)', 'timeFrame': 'From 0-180 minutes post-intervention'}, {'measure': 'Change in plasma glucose levels', 'timeFrame': 'From 0-180 minutes post-intervention'}, {'measure': 'Incidence rate of hyperglycemia (PG > 10 mmol/l)', 'timeFrame': 'From 0-180 minutes post-intervention'}, {'measure': 'Nadir plasma glucose concentration', 'timeFrame': 'From 0-180 minutes post-intervention'}, {'measure': 'Peak plasma glucose concentration', 'timeFrame': 'From 0-180 minutes post-intervention'}, {'measure': 'Incremental peak in plasma glucose concentration', 'timeFrame': 'From 0-180 minutes post-intervention'}, {'measure': 'Mean plasma glucose concentration', 'timeFrame': 'From 0-180 minutes post-intervention'}, {'measure': 'Plasma glucose Area Under the Curve (AUC)', 'timeFrame': 'From 0 to 180 min post-intervention'}, {'measure': 'Percentage of time in hyperglycemia (PG > 10 mmol/l)', 'timeFrame': 'From 0-180 minutes post-intervention'}, {'measure': 'Change in visual analogue scale (VAS) for nausea, headache, stomachache, injection site pain and palpitations from intervention (tintervention = 0) to 180 min post-intervention', 'timeFrame': 'From 0-180 minutes post-intervention'}, {'measure': 'Mean absolute relative difference (MARD) during the 60-minutes exercise session (using SMBG as the reference value)', 'timeFrame': 'During exercise'}, {'measure': 'MARD during the three-day outpatient period (using the 5 daily SMBG as the reference value)', 'timeFrame': 'During the three-day outpatient period'}, {'measure': 'MARD during the three-hour inpatient study visit (using YSI as reference value)', 'timeFrame': 'During exercise'}, {'measure': 'Rate-of change (ROC) accuracy (using SMBG and YSI as the reference value)', 'timeFrame': 'During exercise and during the three-day outpatient period'}, {'measure': 'Point accuracy with the Clarke Error Grid Analysis (CEGA) (using SMBG and YSI as the reference value)', 'timeFrame': 'During exercise and during the three-day outpatient period'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Type 1 Diabetes', 'Exercise', 'Hypoglycemia', 'Glucagon', 'Continuous Glucose Monitoring'], 'conditions': ['Type 1 Diabetes', 'Hypoglycemia']}, 'descriptionModule': {'briefSummary': '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).\n\nThe secondary aim is to compare the accuracy of three continuous glucose monitors (CGM) during and after exercise in inpatient and outpatient settings.', 'detailedDescription': '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.\n\nDuring 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥ 18\n* T1D ≥ 2 years\n* Use of insulin pump or MDI therapy for ≥ 6 months\n* Current use of insulin aspart\n* HbA1c ≤ 70mmol/mol (8.5%)\n* Body mass index (BMI) ≤ 30 kg/m2\n* Performs exercise ≥1 time per week\n\nExclusion Criteria:\n\n* Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period and within 30 days prior to study start\n* Professional athletes or highly active individuals ( ≥ 5 hours of exercise per week)\n* Known or suspected allergies to glucagon or related products\n* History of hypersensitivity or allergic reaction to glucagon or lactose\n* Allergy to the patch of the CGM devices\n* Patients with pheochromocytoma, insulinoma or gastroparesis\n* Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (methods are considered adequate for study enrollment for females: an intrauterine device, hormonal contraception (birth control pills, implant, patch, vaginal ring or injection), a single partner who is sterile or infertile, or sexual abstinence. Contraception is required throughout the study duration. Sterilized or postmenopausal women (\\>12 months since last period) are not required to use contraception)\n* Inability to understand the individual information and to give informed consent\n* Current participation in another clinical trial that, in the judgment of the investigator, will compromise the results of the study or the safety of the subject\n* Concomitant medical or psychological conditions identified through review of medical history, physical examination and clinical laboratory analysis that, according to the investigator's assessment, makes the individual unsuitable for study participation"}, 'identificationModule': {'nctId': 'NCT05076292', 'briefTitle': 'Low-dose Glucagon for Prevention of Exercise-Induced Hypoglycemia in People With Type 1 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Steno Diabetes Center Copenhagen'}, 'officialTitle': 'Low-dose Glucagon for Prevention of Exercise-Induced Hypoglycemia in People With Type 1 Diabetes', 'orgStudyIdInfo': {'id': '78618'}, 'secondaryIdInfos': [{'id': '2021-001342-34', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '150 ug glucagon before exercise', 'description': '150 ug glucagon will be administered subcutaneously just before exercise and placebo will be administered after exercise.', 'interventionNames': ['Drug: GlucaGen']}, {'type': 'EXPERIMENTAL', 'label': '2*75 ug glucagon before exercise and after exercise', 'description': '75 ug glucagon will be administered subcutaneously just before exercise and another 75 ug of glucagon will be administered immediately after exercise.', 'interventionNames': ['Drug: GlucaGen']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Saline as placebo', 'description': 'Saline as placebo will be administered in the same amount as glucagon before and after exercise.', 'interventionNames': ['Drug: Saline']}], 'interventions': [{'name': 'GlucaGen', 'type': 'DRUG', 'otherNames': ['Glucagon, GlucaGen®, Novo Nordisk, ATC code H04AA01'], 'description': '150 ug or 75\\*2 ug glucagon will be administered subcutaneously to the participants before and after exercise.', 'armGroupLabels': ['150 ug glucagon before exercise', '2*75 ug glucagon before exercise and after exercise']}, {'name': 'Saline', 'type': 'DRUG', 'otherNames': ['ATC-code: Natriumklorid isotonisk "BAUER" B05BB01, V07AB'], 'description': 'Saline will be used as placebo before and after exercise.', 'armGroupLabels': ['Saline as placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2820', 'city': 'Gentofte Municipality', 'country': 'Denmark', 'facility': 'Sissel Banner Lundemose', 'geoPoint': {'lat': 55.74903, 'lon': 12.54601}}], 'overallOfficials': [{'name': 'Sissel B Lundemose, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Steno Diabetes Center Copenhagen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Steno Diabetes Center Copenhagen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-03-28', 'type': 'RELEASE'}, {'date': '2025-04-16', 'type': 'RESET'}, {'date': '2025-08-28', 'type': 'RELEASE'}, {'date': '2025-09-16', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Steno Diabetes Center Copenhagen'}}}}