Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2026-02-25 @ 11:46 PM
Study NCT ID:
NCT02012166
Status:
COMPLETED
Last Update Posted:
2015-08-19
First Post:
2013-12-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of MK-0893 on Glucagon-Induced Glycemic Excursion in Healthy Male Participants Following Intravenous Administration of Glucagon, Sandostatine® and Insulin (MK-0893-002)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}], 'ancestors': [{'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C575263', 'term': 'N-((4-(1-(3-(3,5-dichlorophenyl)-5-(6-methoxynaphthalen-2-yl)-1H-pyrazol-1-yl)ethyl)phenyl)carbonyl)-beta-alanine'}, {'id': 'D015282', 'term': 'Octreotide'}, {'id': 'D007328', 'term': 'Insulin'}, {'id': 'D005934', 'term': 'Glucagon'}, {'id': 'D052216', 'term': 'Glucagon-Like Peptide 1'}], 'ancestors': [{'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011384', 'term': 'Proinsulin'}, {'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D052336', 'term': 'Proglucagon'}, {'id': 'D004763', 'term': 'Glucagon-Like Peptides'}, {'id': 'D005768', 'term': 'Gastrointestinal Hormones'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2005-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-18', 'studyFirstSubmitDate': '2013-12-03', 'studyFirstSubmitQcDate': '2013-12-10', 'lastUpdatePostDateStruct': {'date': '2015-08-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-infusion Incremental Glucose Area Under the Plasma Concentration Versus Time Curve [AUC0-240 min] Study Part 1', 'timeFrame': 'Up to 76 hours postdose'}, {'measure': 'Post-infusion Incremental Glucose Area Under the Plasma Concentration Versus Time Curve [AUC0-240 min] Study Part 2', 'timeFrame': 'Up to 124 hours postdose'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With An Adverse Event (AE)', 'timeFrame': 'Up to 12 weeks'}, {'measure': 'Number of Participants Who Discontinued Study Treatment Due To AEs', 'timeFrame': 'Up to 21 days of each treatment period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diabetes Mellitus', 'Diabetes Mellitus, Type 2', 'Glucose Metabolism Disorders', 'Metabolic Diseases', 'Endocrine System Diseases', 'Therapeutic Uses', 'Pharmacologic Actions', 'Molecular Mechanisms of Pharmacological Action', 'Physiological Effects of Drugs'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'This is a study to assess the pharmacokinetics, safety, and tolerability of sequential single oral doses of MK-8093 10 mg, 40 mg, 200 mg, or placebo to MK-8093 (Part 1) depending on treatment assignment in young healthy male participants. In Part 2 of this study, sequential single oral doses of MK-8093 200 mg, 1000 mg or placebo to MK-8093 depending on treatment assignment will be evaluated. The primary hypothesis of the study is that at least one dose of MK-0893 will produce greater reduction of glucagon-induced glycemia as compared to placebo following the infusion of glucagon, Sandostatine®, and basal insulin.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Good health\n* Body Mass Index of between 18 and 28 kg/m\\^2, or up to 30 kg/m\\^2 with approval of sponsor\n* Non-smoker for at least 6 months\n* Willing to avoid strenuous physical activity\n* Willing to avoid alcohol, caffeine, and grapefruit juice consumption\n\nExclusion Criteria:\n\n* History of renal, neurologic, gastrointestinal or respiratory disease or any gastrointestinal surgery\n* History of multiple and/or severe allergies to a prescription, nonprescription or investigational drug or food\n* History of any cardiovascular/cardiac disease\n* History of any hepatic disease and primary biliary cirrhosis\n* History of hypoglycemia or glucose intolerance, type 1 diabetes, or type 2 diabetes\n* Requires or anticipates use of prescription or nonprescription medications, including herbal remedies\n* A user of any illicit drugs or a history of drug or alcohol abuse\n* Surgery, donated a unit of blood, or participated in another clinical study within 4 weeks prior to study participation\n* History of hypersensitivity to insulin, glucagon, or Sandostatine®.'}, 'identificationModule': {'nctId': 'NCT02012166', 'briefTitle': 'A Study of MK-0893 on Glucagon-Induced Glycemic Excursion in Healthy Male Participants Following Intravenous Administration of Glucagon, Sandostatine® and Insulin (MK-0893-002)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Double-Blind, Randomized, Placebo-Controlled, Single-Dose, 3-Period, 4 Treatment Incomplete Crossover Study to Assess the Effects of Single Oral Doses of L-001241689 on Glucagon-Induced Glycemic Excursion in Healthy Male Subjects Following Intravenous Administration of Glucagon, Sandostatine® and Insulin', 'orgStudyIdInfo': {'id': '0893-002'}, 'secondaryIdInfos': [{'id': '2005-002198-57', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MK-0893 40 mg→MK-0893 200 mg→placebo', 'description': 'In Part 1 of the study, participants receive MK-0893 (10 mg, 40 mg or 200 mg) or placebo on Day 1 of each period, and Sandostatine® (30 ng/kg/min), insulin (0.10 mIU/kg/min), and glucagon (3 ng/kg/min) at 24 and 72 hours post dose. In Part 2 of the study, participants receive MK-0893 (200 mg or 1000 mg) or placebo on Day 1 of each period and Sandostatine®, insulin, and glucagon at 120 hours post dose. There will be at least 21 days between administrations of study drugs.', 'interventionNames': ['Drug: MK-0893 40 mg', 'Drug: MK-0893 200 mg', 'Drug: Placebo', 'Biological: Sandostatine®', 'Biological: Insulin', 'Biological: Glucagon']}, {'type': 'EXPERIMENTAL', 'label': 'MK-0893 200 mg→placebo→MK-0893 10 mg', 'description': 'In Part 1 of the study, participants receive MK-0893 (10 mg, 40 mg or 200 mg) or placebo on Day 1 of each period, and Sandostatine® (30 ng/kg/min), insulin (0.10 mIU/kg/min), and glucagon (3 ng/kg/min) at 24 and 72 hours post dose. In Part 2 of the study, participants receive MK-0893 (200 mg or 1000 mg) or placebo on Day 1 of each period and Sandostatine®, insulin, and glucagon at 120 hours post dose. There will be at least 21 days between administrations of study drugs.', 'interventionNames': ['Drug: MK-0893 10 mg', 'Drug: MK-0893 200 mg', 'Drug: Placebo', 'Biological: Sandostatine®', 'Biological: Insulin', 'Biological: Glucagon']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo→MK-0893 10 mg→MK-0893 40 mg', 'description': 'In Part 1 of the study, participants receive MK-0893 (10 mg, 40 mg or 200 mg) or placebo on Day 1 of each period, and Sandostatine® (30 ng/kg/min), insulin (0.10 mIU/kg/min), and glucagon (3 ng/kg/min) at 24 and 72 hours post dose. In Part 2 of the study, participants receive MK-0893 (200 mg or 1000 mg) or placebo on Day 1 of each period and Sandostatine®, insulin, and glucagon at 120 hours post dose. There will be at least 21 days between administrations of study drugs.', 'interventionNames': ['Drug: MK-0893 10 mg', 'Drug: MK-0893 40 mg', 'Drug: Placebo', 'Biological: Sandostatine®', 'Biological: Insulin', 'Biological: Glucagon']}, {'type': 'EXPERIMENTAL', 'label': 'MK-0893 10 mg→MK-0893 40 mg→MK-0893 200 mg', 'description': 'In Part 1 of the study, participants receive MK-0893 (10 mg, 40 mg or 200 mg) or placebo on Day 1 of each period, and Sandostatine® (30 ng/kg/min), insulin (0.10 mIU/kg/min), and glucagon (3 ng/kg/min) at 24 and 72 hours post dose. In Part 2 of the study, participants receive MK-0893 (200 mg or 1000 mg) or placebo on Day 1 of each period and Sandostatine®, insulin, and glucagon at 120 hours post dose. There will be at least 21 days between administrations of study drugs.', 'interventionNames': ['Drug: MK-0893 10 mg', 'Drug: MK-0893 40 mg', 'Drug: MK-0893 200 mg', 'Biological: Sandostatine®', 'Biological: Insulin', 'Biological: Glucagon']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo→MK-0893 1000 mg→MK-0893 200 mg', 'description': 'In Part 1 of the study, participants receive MK-0893 (10 mg, 40 mg or 200 mg) or placebo on Day 1 of each period, and Sandostatine® (30 ng/kg/min), insulin (0.10 mIU/kg/min), and glucagon (3 ng/kg/min) at 24 and 72 hours post dose. In Part 2 of the study, participants receive MK-0893 (200 mg or 1000 mg) or placebo on Day 1 of each period and Sandostatine®, insulin, and glucagon at 120 hours post dose. There will be at least 21 days between administrations of study drugs.', 'interventionNames': ['Drug: MK-0893 200 mg', 'Drug: MK-0893 1000 mg', 'Drug: Placebo', 'Biological: Sandostatine®', 'Biological: Insulin', 'Biological: Glucagon']}, {'type': 'EXPERIMENTAL', 'label': 'MK-0893 200 mg→placebo→MK-0893 1000 mg', 'description': 'In Part 1 of the study, participants receive MK-0893 (10 mg, 40 mg or 200 mg) or placebo on Day 1 of each period, and Sandostatine® (30 ng/kg/min), insulin (0.10 mIU/kg/min), and glucagon (3 ng/kg/min) at 24 and 72 hours post dose. In Part 2 of the study, participants receive MK-0893 (200 mg or 1000 mg) or placebo on Day 1 of each period and Sandostatine®, insulin, and glucagon at 120 hours post dose. There will be at least 21 days between administrations of study drugs.', 'interventionNames': ['Drug: MK-0893 200 mg', 'Drug: MK-0893 1000 mg', 'Drug: Placebo', 'Biological: Sandostatine®', 'Biological: Insulin', 'Biological: Glucagon']}, {'type': 'EXPERIMENTAL', 'label': 'MK-0893 1000 mg→MK-0893 200 mg→placebo', 'description': 'In Part 1 of the study, participants receive MK-0893 (10 mg, 40 mg or 200 mg) or placebo on Day 1 of each period, and Sandostatine® (30 ng/kg/min), insulin (0.10 mIU/kg/min), and glucagon (3 ng/kg/min) at 24 and 72 hours post dose. In Part 2 of the study, participants receive MK-0893 (200 mg or 1000 mg) or placebo on Day 1 of each period and Sandostatine®, insulin, and glucagon at 120 hours post dose. There will be at least 21 days between administrations of study drugs.', 'interventionNames': ['Drug: MK-0893 200 mg', 'Drug: MK-0893 1000 mg', 'Drug: Placebo', 'Biological: Sandostatine®', 'Biological: Insulin', 'Biological: Glucagon']}], 'interventions': [{'name': 'MK-0893 10 mg', 'type': 'DRUG', 'description': 'MK-0893 10 mg administered orally in 240 mL of water', 'armGroupLabels': ['MK-0893 10 mg→MK-0893 40 mg→MK-0893 200 mg', 'MK-0893 200 mg→placebo→MK-0893 10 mg', 'Placebo→MK-0893 10 mg→MK-0893 40 mg']}, {'name': 'MK-0893 40 mg', 'type': 'DRUG', 'description': 'MK-0893 40 mg administered orally in 240 mL of water', 'armGroupLabels': ['MK-0893 10 mg→MK-0893 40 mg→MK-0893 200 mg', 'MK-0893 40 mg→MK-0893 200 mg→placebo', 'Placebo→MK-0893 10 mg→MK-0893 40 mg']}, {'name': 'MK-0893 200 mg', 'type': 'DRUG', 'description': 'MK-0893 200 mg administered orally in 240 mL of water', 'armGroupLabels': ['MK-0893 10 mg→MK-0893 40 mg→MK-0893 200 mg', 'MK-0893 1000 mg→MK-0893 200 mg→placebo', 'MK-0893 200 mg→placebo→MK-0893 10 mg', 'MK-0893 200 mg→placebo→MK-0893 1000 mg', 'MK-0893 40 mg→MK-0893 200 mg→placebo', 'Placebo→MK-0893 1000 mg→MK-0893 200 mg']}, {'name': 'MK-0893 1000 mg', 'type': 'DRUG', 'description': 'MK-0893 1000 mg administered orally in 240 mL of water', 'armGroupLabels': ['MK-0893 1000 mg→MK-0893 200 mg→placebo', 'MK-0893 200 mg→placebo→MK-0893 1000 mg', 'Placebo→MK-0893 1000 mg→MK-0893 200 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo administered orally in 240 mL of water', 'armGroupLabels': ['MK-0893 1000 mg→MK-0893 200 mg→placebo', 'MK-0893 200 mg→placebo→MK-0893 10 mg', 'MK-0893 200 mg→placebo→MK-0893 1000 mg', 'MK-0893 40 mg→MK-0893 200 mg→placebo', 'Placebo→MK-0893 10 mg→MK-0893 40 mg', 'Placebo→MK-0893 1000 mg→MK-0893 200 mg']}, {'name': 'Sandostatine®', 'type': 'BIOLOGICAL', 'otherNames': ['Octreotide acetate'], 'description': 'Sandostatine® is a somatostatin analogue. At 24 and at 72 (Part I) or 120 (Part II) hours postdose, simultaneous infusions of the Sandostatine®, insulin, and glucagon will be administered over a 2-hour period. These compounds are IV compatible and will be combined in one syringe. Intravenous Sandostatine® will be administered at 30 ng/kg/min.', 'armGroupLabels': ['MK-0893 10 mg→MK-0893 40 mg→MK-0893 200 mg', 'MK-0893 1000 mg→MK-0893 200 mg→placebo', 'MK-0893 200 mg→placebo→MK-0893 10 mg', 'MK-0893 200 mg→placebo→MK-0893 1000 mg', 'MK-0893 40 mg→MK-0893 200 mg→placebo', 'Placebo→MK-0893 10 mg→MK-0893 40 mg', 'Placebo→MK-0893 1000 mg→MK-0893 200 mg']}, {'name': 'Insulin', 'type': 'BIOLOGICAL', 'otherNames': ['Humuline Regular, Insulin for human injection'], 'description': 'At 24 and at 72 (Part I) or 120 (Part II) hours postdose, simultaneous infusions of the Sandostatine®, insulin, and glucagon will be administered over a 2-hour period. These compounds are IV compatible and will be combined in one syringe. Intravenous insulin will be administered at 0.10 milli-international unit (mIU)/kg/min.', 'armGroupLabels': ['MK-0893 10 mg→MK-0893 40 mg→MK-0893 200 mg', 'MK-0893 1000 mg→MK-0893 200 mg→placebo', 'MK-0893 200 mg→placebo→MK-0893 10 mg', 'MK-0893 200 mg→placebo→MK-0893 1000 mg', 'MK-0893 40 mg→MK-0893 200 mg→placebo', 'Placebo→MK-0893 10 mg→MK-0893 40 mg', 'Placebo→MK-0893 1000 mg→MK-0893 200 mg']}, {'name': 'Glucagon', 'type': 'BIOLOGICAL', 'otherNames': ['Glucagen'], 'description': 'At 24 and at 72 (Part I) or 120 (Part II) hours postdose, simultaneous infusions of the Sandostatine®, insulin, and glucagon will be administered over a 2-hour period. These compounds are IV compatible and will be combined in one syringe. Intravenous glucagon will be administered at 3 ng/kg/min.', 'armGroupLabels': ['MK-0893 10 mg→MK-0893 40 mg→MK-0893 200 mg', 'MK-0893 1000 mg→MK-0893 200 mg→placebo', 'MK-0893 200 mg→placebo→MK-0893 10 mg', 'MK-0893 200 mg→placebo→MK-0893 1000 mg', 'MK-0893 40 mg→MK-0893 200 mg→placebo', 'Placebo→MK-0893 10 mg→MK-0893 40 mg', 'Placebo→MK-0893 1000 mg→MK-0893 200 mg']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}