Viewing Study NCT01373450

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Ignite Creation Date: 2025-12-24 @ 5:00 PM
Ignite Modification Date: 2025-12-29 @ 7:04 AM
Study NCT ID: NCT01373450
Status: COMPLETED
Last Update Posted: 2015-09-02
First Post: 2011-06-13
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Evaluation of the Glucoregulatory Effects of Glucagon-like Peptide-1 Receptor (GLP-1 Receptor) Activation in Participants With Type 2 Diabetes Mellitus (MK-0000-222)
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D053772', 'term': 'Oxyntomodulin'}, {'id': 'D000069450', 'term': 'Liraglutide'}], 'ancestors': [{'id': 'D052336', 'term': 'Proglucagon'}, {'id': 'D005768', 'term': 'Gastrointestinal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D052216', 'term': 'Glucagon-Like Peptide 1'}, {'id': 'D004763', 'term': 'Glucagon-Like Peptides'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': 'The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 14 days after last dose of study medication', 'eventGroups': [{'id': 'EG000', 'title': 'Oxyntomodulin', 'description': 'Oxyntomodulin 3.0 pmol/kg/min IV infusion', 'otherNumAtRisk': 12, 'otherNumAffected': 6, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Liraglutide 0.6 mg', 'description': 'Liraglutide 0.6 mg subcutaneous', 'otherNumAtRisk': 12, 'otherNumAffected': 7, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Liraglutide 1.2 mg', 'description': 'Liraglutide 1.2 mg subcutaneous', 'otherNumAtRisk': 6, 'otherNumAffected': 1, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Placebo', 'description': 'Placebo for Oxyntomodulin IV infusion and Placebo for Liraglutide subcutaneous', 'otherNumAtRisk': 12, 'otherNumAffected': 8, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Salivary Hypersecretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Catheter Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Catheter Site Related Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 2}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Oedema Peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Musculoskeletal Stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pruritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 15.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Time-weighted Average of Glucose Measured by Area Under the Curve (AUC) After a Single Dose of Oxyntomodulin (OXM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxyntomodulin', 'description': 'Oxyntomodulin 3.0 pmol/kg/min IV infusion'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for Oxyntomodulin IV infusion and Placebo for Liraglutide subcutaneous'}], 'classes': [{'categories': [{'measurements': [{'value': '106.3', 'spread': '23.03', 'groupId': 'OG000'}, {'value': '122.6', 'spread': '35.29', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.024', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.87', 'ciLowerLimit': '0.77', 'ciUpperLimit': '0.98', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and during GGI at time points 0, 20, 40, 60, 80, 100, 120, 140, 160 and 165 minutes', 'description': 'Participants received on Day (-1) an overnight intravenous (IV) infusion of insulin titrated to achieve baseline fasting plasma glucose on Day 1 of between 90 and 130 mg/dL. Participants also received on Day (-1) a single dose of liraglutide (Lg) or placebo for Lg, after which insulin infusion was discontinued. Following overnight fast, participants received on Day 1 OXM or placebo for OXM, accompanied by up to 160 minutes of graded glucose infusion (GGI). During GGI glucose (20% D/W) was gradually infused at rates of 2,4,6 and 10 mg/kg/min, with each rate lasting approximately 40 minutes. Glucose levels were measured from blood collected at baseline and during GGI at the following minutes: 0, 20, 40, 60, 80, 100, 120, 140, 160 and 165 in order to calculate the time-weighted average change from baseline in glucose AUC from 0-160 minutes.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants treated with Oxyntomodulin or placebo. Six participants were treated for two periods with placebo, resulting in placebo n = 18. Participants treated with Liraglutide were not analyzed for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Maximum Ambient Glucose Concentration (Gmax) After a Single Dose of OXM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxyntomodulin', 'description': 'Oxyntomodulin 3.0 pmol/kg/min IV infusion'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for Oxyntomodulin IV infusion and Placebo for Liraglutide subcutaneous'}], 'classes': [{'categories': [{'measurements': [{'value': '211.0', 'spread': '63.00', 'groupId': 'OG000'}, {'value': '272.9', 'spread': '50.05', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.77', 'ciLowerLimit': '0.66', 'ciUpperLimit': '0.90', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and up to 160 minutes after start of GGI', 'description': 'Participants received on Day (-1) an overnight IV infusion of insulin titrated to achieve baseline fasting plasma glucose on Day 1 of between 90 and 130 mg/dL. Participants also received on Day (-1) a single dose of Lg or placebo for Lg, after which insulin infusion was discontinued. Following overnight fast, participants received on Day 1 OXM or placebo for OXM, accompanied by up to 160 minutes of GGI. During GGI glucose (20% D/W) was gradually infused at rates of 2,4,6 and 10 mg/kg/min, with each rate lasting approximately 40 minutes. Glucose levels were measured from blood collected at baseline and during GGI to determine the maximum ambient glucose concentration above baseline.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants treated with Oxyntomodulin or placebo. Six participants were treated for two periods with placebo, resulting in placebo n = 18. Participants treated with Liraglutide were not analyzed for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Beta Cell Sensitivity to Glucose (Φ) After a Single Dose of OXM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxyntomodulin', 'description': 'Oxyntomodulin 3.0 pmol/kg/min IV infusion'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for Oxyntomodulin IV infusion and Placebo for Liraglutide subcutaneous'}], 'classes': [{'categories': [{'measurements': [{'value': '0.019', 'spread': '0.010', 'groupId': 'OG000', 'lowerLimit': '0.013'}, {'value': '0.006', 'spread': '0.003', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Square Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.014', 'ciLowerLimit': '0.008', 'ciUpperLimit': '0.019', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and up to160 minutes after start of GGI', 'description': 'Beta cell sensitivity measures the ability to mount an insulin secretory response relative to the level of ambient plasma glucose. Participants received on Day (-1) an overnight IV infusion of insulin titrated to achieve baseline fasting plasma glucose on Day 1 of between 90 and 130 mg/dL. Participants also received on Day (-1) a single dose of Lg or placebo for Lg, after which insulin infusion was discontinued. Following overnight fast, participants received on Day 1 a single dose of OXM or placebo for OXM, accompanied by up to 160 minutes of GGI. During GGI glucose (20% D/W) was gradually infused at rates of 2,4,6 and 10 mg/kg/min, with each rate lasting 40 minutes. Glucose (G), insulin and C-peptide levels were measured from blood collected at baseline and during GGI, with the decay in C-peptide concentration used to indirectly estimate the Insulin Secretion Rate (ISR). Beta Cell Sensitivity (Φ) was determined from the regression of the ISR on ambient plasma glucose (G).', 'unitOfMeasure': 'ISR (ng/mL) / Glucose (mg/dL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants treated with Oxyntomodulin or placebo. Six participants were treated for two periods with placebo, resulting in placebo n = 18. Participants treated with Liraglutide were not analyzed for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Insulinotrophic Effect (ISR/G) at the Highest Glucose Infusion Rate After Two Periods of Placebo Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Period 1', 'description': 'Placebo for Oxyntomodulin IV infusion and Placebo for Liraglutide subcutaneous'}, {'id': 'OG001', 'title': 'Placebo Period 2', 'description': 'Placebo for Oxyntomodulin IV infusion and Placebo for Liraglutide subcutaneous'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0075', 'spread': '0.0031', 'groupId': 'OG000'}, {'value': '0.0070', 'spread': '0.0027', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Intraclass Correlation Coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.92', 'ciLowerLimit': '0.72', 'ciUpperLimit': '0.98', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 160 minutes after start of GGI at each placebo treatment period', 'description': 'The reproducibility of insulinotrophic effects was compared after two separate placebo treatment periods within the same treatment sequence. Participants received on Day (-1) an overnight IV infusion of insulin titrated to achieve baseline fasting plasma glucose on Day 1 of between 90 and 130 mg/dL. Participants also received on Day (-1) a single subcutaneous dose of placebo for Lg, after which insulin infusion was discontinued. Following overnight fast, participants received on Day 1 placebo for OXM, accompanied by up to 160 minutes of GGI. During GGI glucose (20% D/W) was gradually infused at rates of 2,4,6 and 10 mg/kg/min, with each rate lasting approximately 40 minutes. Over these two treatment periods glucose (G), insulin and C-peptide levels were measured from blood collected at the highest glucose infusion rate; with the decay in C-peptide concentration used to indirectly estimate the Insulin Secretion Rate (ISR), and hence to determine the insulinotrophic effect, ISR/G.', 'unitOfMeasure': 'ISR (ng/mg) / Glucose (mg/dL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants within the same treatment sequence who were treated with Placebo in two separate treatment periods. Participants treated with Oxyntomodulin or Liraglutide were not analyzed for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Gmax After Single Doses of 0.6 mg Lg, or 1.2 mg Lg, Compared With Single Doses of Placebo or OXM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide 0.6 mg', 'description': 'Liraglutide 0.6 mg subcutaneous'}, {'id': 'OG001', 'title': 'Liraglutide 1.2 mg', 'description': 'Liraglutide 1.2 mg subcutaneous'}, {'id': 'OG002', 'title': 'Oxyntomodulin', 'description': 'Oxyntomodulin 3.0 pmol/kg/min IV infusion'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo for Oxyntomodulin IV infusion and Placebo for Liraglutide subcutaneous'}], 'classes': [{'categories': [{'measurements': [{'value': '209.7', 'spread': '66.08', 'groupId': 'OG000'}, {'value': '157.9', 'spread': '93.36', 'groupId': 'OG001'}, {'value': '211.0', 'spread': '63.00', 'groupId': 'OG002'}, {'value': '272.9', 'spread': '50.05', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.77', 'ciLowerLimit': '0.66', 'ciUpperLimit': '0.90', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.58', 'ciLowerLimit': '0.45', 'ciUpperLimit': '0.74', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.473', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.99', 'ciLowerLimit': '0.85', 'ciUpperLimit': '1.16', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.049', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.75', 'ciLowerLimit': '0.56', 'ciUpperLimit': '1.00', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and up to 160 minutes after start of GGI', 'description': 'Participants received on Day (-1) an overnight IV infusion of insulin titrated to achieve baseline fasting plasma glucose on Day 1 of between 90 and 130 mg/dL. Participants also received on Day (-1) a single dose of Lg or placebo for Lg, after which insulin infusion was discontinued. Following overnight fast, participants received on Day 1 a single dose of OXM or placebo for OXM, accompanied by up to 160 minutes of GGI. During GGI glucose (20% D/W) was gradually infused at rates of 2,4,6 and 10 mg/kg/min, with each rate lasting approximately 40 minutes. Glucose levels were measured from blood collected at baseline and during GGI to determine the maximum ambient glucose concentration above baseline.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants. Six participants were treated for two periods with placebo, resulting in a placebo n = 18.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Insulinotrophic Effect (ISR/G) After Single Doses of 0.6 mg Lg, or 1.2 mg Lg, Compared With Single Doses of Placebo or OXM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide 0.6 mg', 'description': 'Liraglutide 0.6 mg subcutaneous'}, {'id': 'OG001', 'title': 'Liraglutide 1.2 mg', 'description': 'Liraglutide 1.2 mg subcutaneous'}, {'id': 'OG002', 'title': 'Oxyntomodulin', 'description': 'Oxyntomodulin 3.0 pmol/kg/min IV infusion'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo for Oxyntomodulin IV infusion and Placebo for Liraglutide subcutaneous'}], 'classes': [{'categories': [{'measurements': [{'value': '0.026', 'spread': '0.015', 'groupId': 'OG000'}, {'value': '0.035', 'spread': '0.018', 'groupId': 'OG001'}, {'value': '0.019', 'spread': '0.010', 'groupId': 'OG002'}, {'value': '0.006', 'spread': '0.003', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Least Square Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.021', 'ciLowerLimit': '0.015', 'ciUpperLimit': '0.026', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Least Square Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.030', 'ciLowerLimit': '0.021', 'ciUpperLimit': '0.038', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0163', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Square Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.007', 'ciLowerLimit': '0.002', 'ciUpperLimit': '0.012', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0056', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least Square Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.016', 'ciLowerLimit': '0.006', 'ciUpperLimit': '0.026', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and up to 160 minutes after start of GGI', 'description': 'Participants received on Day (-1) an overnight IV infusion of insulin titrated to achieve baseline fasting plasma glucose on Day 1 of between 90 and 130 mg/dL. Participants also received on Day (-1) a single dose of Lg or placebo for Lg, after which insulin infusion was discontinued. Following overnight fast, participants received on Day 1 a single dose of OXM or placebo for OXM, accompanied by up to 160 minutes of GGI. During GGI glucose (20% D/W) was gradually infused at rates of 2,4,6 and 10 mg/kg/min, with each rate lasting approximately 40 minutes. Glucose (G), insulin and C-peptide levels were measured from blood collected at baseline and during GGI; with the decay in C-peptide concentration used to indirectly estimate the Insulin Secretion Rate (ISR) and hence determine ISR/G.', 'unitOfMeasure': 'ISR (ng/min) / Glucose (mg/dL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants. Six participants were treated for two periods with placebo, resulting in placebo n = 18.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'OXM --> Lg-0.6--> Pbo--> Lg-1.2', 'description': 'Participants received Oxyntomodulin (OXM) 3.0 pmol/kg/min in the first, Liraglutide (Lg) 0.6 mg in the second, Placebo (Pbo) in the third, and Liraglutide 1.2 mg in the fourth period'}, {'id': 'FG001', 'title': 'Lg-0.6 mg--> Pbo--> OXM--> Pbo', 'description': 'Participants received Liraglutide 0.6 mg in the first, Placebo in the second, Oxyntomodulin 3.0 pmol/kg/min in the third, and Placebo in the fourth period'}, {'id': 'FG002', 'title': 'Pbo--> OXM--> Lg-0.6-->Pbo', 'description': 'Participants received Placebo in the first, Oxyntomodulin 3.0 pmol/kg/min in the second, Liraglutide 0.6 mg in the third, and Placebo in the fourth period'}, {'id': 'FG003', 'title': 'Lg-0.6--> OXM--> Pbo--> Lg-1.2', 'description': 'Participants received Liraglutide 0.6 mg in the first, Oxyntomodulin 3.0 pmol/kg/min in the second, Placebo in the third and Liraglutide 1.2 mg in the fourth period'}, {'id': 'FG004', 'title': 'OXM--> Pbo--> Lg-0.6--> Pbo', 'description': 'Participants received Oxyntomodulin 3.0 pmol/kg/min in the first; Placebo in the second, Liraglutide 0.6 mg in the third, and Placebo in the fourth period'}, {'id': 'FG005', 'title': 'Pbo--> Lg-0.6--> OXM--> Lg-1.2', 'description': 'Participants received Placebo in the first, Liraglutide 0.6 mg in the second, Oxyntomodulin 3.0 pmol/kg/min in the third, and Liraglutide 1.2 mg in the fourth period'}], 'periods': [{'title': 'Crossover Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': '7 Day Wash-out', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Crossover Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': '7 Day Wash-out', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Crossover Period 3', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': '7 Day Wash-out', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Crossover Period 4', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Treated Participants'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.8', 'spread': '3.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-01', 'studyFirstSubmitDate': '2011-06-13', 'resultsFirstSubmitDate': '2013-05-20', 'studyFirstSubmitQcDate': '2011-06-13', 'lastUpdatePostDateStruct': {'date': '2015-09-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-05-20', 'studyFirstPostDateStruct': {'date': '2011-06-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-07-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Time-weighted Average of Glucose Measured by Area Under the Curve (AUC) After a Single Dose of Oxyntomodulin (OXM)', 'timeFrame': 'Baseline and during GGI at time points 0, 20, 40, 60, 80, 100, 120, 140, 160 and 165 minutes', 'description': 'Participants received on Day (-1) an overnight intravenous (IV) infusion of insulin titrated to achieve baseline fasting plasma glucose on Day 1 of between 90 and 130 mg/dL. Participants also received on Day (-1) a single dose of liraglutide (Lg) or placebo for Lg, after which insulin infusion was discontinued. Following overnight fast, participants received on Day 1 OXM or placebo for OXM, accompanied by up to 160 minutes of graded glucose infusion (GGI). During GGI glucose (20% D/W) was gradually infused at rates of 2,4,6 and 10 mg/kg/min, with each rate lasting approximately 40 minutes. Glucose levels were measured from blood collected at baseline and during GGI at the following minutes: 0, 20, 40, 60, 80, 100, 120, 140, 160 and 165 in order to calculate the time-weighted average change from baseline in glucose AUC from 0-160 minutes.'}, {'measure': 'Change From Baseline in Maximum Ambient Glucose Concentration (Gmax) After a Single Dose of OXM', 'timeFrame': 'Baseline and up to 160 minutes after start of GGI', 'description': 'Participants received on Day (-1) an overnight IV infusion of insulin titrated to achieve baseline fasting plasma glucose on Day 1 of between 90 and 130 mg/dL. Participants also received on Day (-1) a single dose of Lg or placebo for Lg, after which insulin infusion was discontinued. Following overnight fast, participants received on Day 1 OXM or placebo for OXM, accompanied by up to 160 minutes of GGI. During GGI glucose (20% D/W) was gradually infused at rates of 2,4,6 and 10 mg/kg/min, with each rate lasting approximately 40 minutes. Glucose levels were measured from blood collected at baseline and during GGI to determine the maximum ambient glucose concentration above baseline.'}, {'measure': 'Change From Baseline in Beta Cell Sensitivity to Glucose (Φ) After a Single Dose of OXM', 'timeFrame': 'Baseline and up to160 minutes after start of GGI', 'description': 'Beta cell sensitivity measures the ability to mount an insulin secretory response relative to the level of ambient plasma glucose. Participants received on Day (-1) an overnight IV infusion of insulin titrated to achieve baseline fasting plasma glucose on Day 1 of between 90 and 130 mg/dL. Participants also received on Day (-1) a single dose of Lg or placebo for Lg, after which insulin infusion was discontinued. Following overnight fast, participants received on Day 1 a single dose of OXM or placebo for OXM, accompanied by up to 160 minutes of GGI. During GGI glucose (20% D/W) was gradually infused at rates of 2,4,6 and 10 mg/kg/min, with each rate lasting 40 minutes. Glucose (G), insulin and C-peptide levels were measured from blood collected at baseline and during GGI, with the decay in C-peptide concentration used to indirectly estimate the Insulin Secretion Rate (ISR). Beta Cell Sensitivity (Φ) was determined from the regression of the ISR on ambient plasma glucose (G).'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Insulinotrophic Effect (ISR/G) at the Highest Glucose Infusion Rate After Two Periods of Placebo Treatment', 'timeFrame': 'Baseline and 160 minutes after start of GGI at each placebo treatment period', 'description': 'The reproducibility of insulinotrophic effects was compared after two separate placebo treatment periods within the same treatment sequence. Participants received on Day (-1) an overnight IV infusion of insulin titrated to achieve baseline fasting plasma glucose on Day 1 of between 90 and 130 mg/dL. Participants also received on Day (-1) a single subcutaneous dose of placebo for Lg, after which insulin infusion was discontinued. Following overnight fast, participants received on Day 1 placebo for OXM, accompanied by up to 160 minutes of GGI. During GGI glucose (20% D/W) was gradually infused at rates of 2,4,6 and 10 mg/kg/min, with each rate lasting approximately 40 minutes. Over these two treatment periods glucose (G), insulin and C-peptide levels were measured from blood collected at the highest glucose infusion rate; with the decay in C-peptide concentration used to indirectly estimate the Insulin Secretion Rate (ISR), and hence to determine the insulinotrophic effect, ISR/G.'}, {'measure': 'Change From Baseline in Gmax After Single Doses of 0.6 mg Lg, or 1.2 mg Lg, Compared With Single Doses of Placebo or OXM', 'timeFrame': 'Baseline and up to 160 minutes after start of GGI', 'description': 'Participants received on Day (-1) an overnight IV infusion of insulin titrated to achieve baseline fasting plasma glucose on Day 1 of between 90 and 130 mg/dL. Participants also received on Day (-1) a single dose of Lg or placebo for Lg, after which insulin infusion was discontinued. Following overnight fast, participants received on Day 1 a single dose of OXM or placebo for OXM, accompanied by up to 160 minutes of GGI. During GGI glucose (20% D/W) was gradually infused at rates of 2,4,6 and 10 mg/kg/min, with each rate lasting approximately 40 minutes. Glucose levels were measured from blood collected at baseline and during GGI to determine the maximum ambient glucose concentration above baseline.'}, {'measure': 'Change From Baseline in Insulinotrophic Effect (ISR/G) After Single Doses of 0.6 mg Lg, or 1.2 mg Lg, Compared With Single Doses of Placebo or OXM', 'timeFrame': 'Baseline and up to 160 minutes after start of GGI', 'description': 'Participants received on Day (-1) an overnight IV infusion of insulin titrated to achieve baseline fasting plasma glucose on Day 1 of between 90 and 130 mg/dL. Participants also received on Day (-1) a single dose of Lg or placebo for Lg, after which insulin infusion was discontinued. Following overnight fast, participants received on Day 1 a single dose of OXM or placebo for OXM, accompanied by up to 160 minutes of GGI. During GGI glucose (20% D/W) was gradually infused at rates of 2,4,6 and 10 mg/kg/min, with each rate lasting approximately 40 minutes. Glucose (G), insulin and C-peptide levels were measured from blood collected at baseline and during GGI; with the decay in C-peptide concentration used to indirectly estimate the Insulin Secretion Rate (ISR) and hence determine ISR/G.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '29545266', 'type': 'DERIVED', 'citation': "Shankar SS, Shankar RR, Mixson LA, Miller DL, Pramanik B, O'Dowd AK, Williams DM, Frederick CB, Beals CR, Stoch SA, Steinberg HO, Kelley DE. Native Oxyntomodulin Has Significant Glucoregulatory Effects Independent of Weight Loss in Obese Humans With and Without Type 2 Diabetes. Diabetes. 2018 Jun;67(6):1105-1112. doi: 10.2337/db17-1331. Epub 2018 Mar 15."}, {'pmid': '27072496', 'type': 'DERIVED', 'citation': 'Shankar SS, Shankar RR, Mixson LA, Miller DL, Chung C, Cilissen C, Beals CR, Stoch SA, Steinberg HO, Kelley DE. Linearity of beta-cell response across the metabolic spectrum and to pharmacology: insights from a graded glucose infusion-based investigation series. Am J Physiol Endocrinol Metab. 2016 Jun 1;310(11):E865-73. doi: 10.1152/ajpendo.00527.2015. Epub 2016 Apr 12.'}]}, 'descriptionModule': {'briefSummary': 'This was a four-period crossover study to assess the glycemic effects of a single dose of oxyntomodulin (OXM) on the glucose levels in participants with Type 2 diabetes mellitus (T2DM). Participants were randomly assigned to 1 of 6 treatment sequences consisting of 4 treatment periods, with a 7-day wash-out between each treatment period. The primary hypothesis was that during graded glucose infusion (GGI) oxyntomodulin (OXM) is neutral or better than placebo (Pbo) at lowering ambient plasma glucose levels, and at significantly enhancing insulin secretion.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have a body mass index (BMI) of ≤38.0 kg/m\\^2\n* Have a clinical diagnosis of Type 2 diabetes mellitus\n* Have a glycated hemoglobin (HbA1C) at screening ≤9.0%; fasting plasma glucose should not exceed 300 mg/dL (16.8 mmol/L)\n* Judged to be in good health\n\nExclusion Criteria:\n\n* Have a history of any illness that, in the opinion of the study investigator, might confound the results of the study or poses an additional risk to the subject by their participation in the study\n* Have a history of stroke, chronic seizures, major neurological disorder, clinically significant endocrine, cardiovascular, hematological, hepatic, renal, respiratory, or genitourinary abnormalities or diseases\n* Have untreated hypertension with blood pressure of \\>160/95 mmHg\n* Have a history of neoplastic disease within the past 5 years\n* Have a history of hypersensitivity to OXM, liraglutide, insulin or Haemaccel®\n* Unable or unwilling to comply with restrictions around concomitant medications\n* Consume excessive amounts of alcohol, coffee, tea, cola, or other caffeinated beverages daily\n* Have had major surgery, donated or lost 1 unit of blood (approximately 500 mL) or participated in another investigational study within 4 weeks\n* Have a history of significant multiple and/or severe allergies, or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food\n* Currently a regular user (including use of any illicit drugs or has a history of drug (including alcohol) abuse within approximately 3 months\n* Are unwilling or unable to consume the standardized meals during the study and/or is on a carbohydrate restricted diet (i.e., a diet \\<100 grams per day of carbohydrate)'}, 'identificationModule': {'nctId': 'NCT01373450', 'briefTitle': 'Evaluation of the Glucoregulatory Effects of Glucagon-like Peptide-1 Receptor (GLP-1 Receptor) Activation in Participants With Type 2 Diabetes Mellitus (MK-0000-222)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'Evaluation of the Glucoregulatory Effects of GLP-1 Receptor Activation in Patients With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': '0000-222'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OXM → Lg-0.6 → Pbo → Lg-1.2', 'description': 'Participants received Oxyntomodulin 3.0 pmol/kg/min in the first, Liraglutide 0.6 mg in the second, Placebo in the third, and Liraglutide 1.2 mg in the fourth period', 'interventionNames': ['Drug: Oxyntomodulin', 'Drug: Liraglutide 0.6 mg', 'Drug: Placebo for Oxyntomodulin', 'Drug: Placebo for Liraglutide']}, {'type': 'EXPERIMENTAL', 'label': 'Lg-0.6 → Pbo → OXM → Pbo', 'description': 'Participants received Liraglutide 0.6 mg in the first, Placebo in the second, Oxyntomodulin 3.0 pmol/kg/min in the third, and Placebo in the fourth period', 'interventionNames': ['Drug: Oxyntomodulin', 'Drug: Liraglutide 0.6 mg', 'Drug: Placebo for Oxyntomodulin', 'Drug: Placebo for Liraglutide']}, {'type': 'EXPERIMENTAL', 'label': 'Pbo → OXM → Lg-0.6 → Pbo', 'description': 'Participants received Placebo in the first, Oxyntomodulin 3.0 pmol/kg/min in the second, Liraglutide 0.6 mg in the third, and Placebo in the fourth period', 'interventionNames': ['Drug: Oxyntomodulin', 'Drug: Liraglutide 0.6 mg', 'Drug: Placebo for Oxyntomodulin', 'Drug: Placebo for Liraglutide']}, {'type': 'EXPERIMENTAL', 'label': 'Lg-0.6 → OXM → Pbo → Lg-1.2', 'description': 'Participants received Liraglutide 0.6 mg in the first, Oxyntomodulin 3.0 pmol/kg/min in the second, Placebo in the third and Liraglutide 1.2 mg in the fourth period', 'interventionNames': ['Drug: Oxyntomodulin', 'Drug: Liraglutide 0.6 mg', 'Drug: Liraglutide 1.2 mg', 'Drug: Placebo for Oxyntomodulin', 'Drug: Placebo for Liraglutide']}, {'type': 'EXPERIMENTAL', 'label': 'OXM → Pbo → Lg-0.6 → Pbo', 'description': 'Participants received Oxyntomodulin 3.0 pmol/kg/min in the first; Placebo in the second, Liraglutide 0.6 mg in the third, and Placebo in the fourth period', 'interventionNames': ['Drug: Oxyntomodulin', 'Drug: Liraglutide 0.6 mg', 'Drug: Placebo for Oxyntomodulin', 'Drug: Placebo for Liraglutide']}, {'type': 'EXPERIMENTAL', 'label': 'Pbo → Lg-0.6 → OXM → Lg-1.2', 'description': 'Participants received Placebo in the first, Liraglutide 0.6 mg in the second, Oxyntomodulin 3.0 pmol/kg/min in the third, and Liraglutide 1.2 mg in the fourth period', 'interventionNames': ['Drug: Oxyntomodulin', 'Drug: Liraglutide 0.6 mg', 'Drug: Liraglutide 1.2 mg', 'Drug: Placebo for Oxyntomodulin', 'Drug: Placebo for Liraglutide']}], 'interventions': [{'name': 'Oxyntomodulin', 'type': 'DRUG', 'description': '3.0 pmol/kg/min as an intravenous (IV) infusion in the morning of the day of graded glucose infusion (GGI) (Day 1)', 'armGroupLabels': ['Lg-0.6 → OXM → Pbo → Lg-1.2', 'Lg-0.6 → Pbo → OXM → Pbo', 'OXM → Lg-0.6 → Pbo → Lg-1.2', 'OXM → Pbo → Lg-0.6 → Pbo', 'Pbo → Lg-0.6 → OXM → Lg-1.2', 'Pbo → OXM → Lg-0.6 → Pbo']}, {'name': 'Liraglutide 0.6 mg', 'type': 'DRUG', 'otherNames': ['Victoza®'], 'description': 'Single subcutaneous dose in the evening of the day before the GGI (Day-1)', 'armGroupLabels': ['Lg-0.6 → OXM → Pbo → Lg-1.2', 'Lg-0.6 → Pbo → OXM → Pbo', 'OXM → Lg-0.6 → Pbo → Lg-1.2', 'OXM → Pbo → Lg-0.6 → Pbo', 'Pbo → Lg-0.6 → OXM → Lg-1.2', 'Pbo → OXM → Lg-0.6 → Pbo']}, {'name': 'Liraglutide 1.2 mg', 'type': 'DRUG', 'otherNames': ['Victoza®'], 'description': 'Single subcutaneous dose in the evening of the day before the GGI (Day-1)', 'armGroupLabels': ['Lg-0.6 → OXM → Pbo → Lg-1.2', 'Pbo → Lg-0.6 → OXM → Lg-1.2']}, {'name': 'Placebo for Oxyntomodulin', 'type': 'DRUG', 'description': 'IV infusion in the morning of the day of GGI (Day 1)', 'armGroupLabels': ['Lg-0.6 → OXM → Pbo → Lg-1.2', 'Lg-0.6 → Pbo → OXM → Pbo', 'OXM → Lg-0.6 → Pbo → Lg-1.2', 'OXM → Pbo → Lg-0.6 → Pbo', 'Pbo → Lg-0.6 → OXM → Lg-1.2', 'Pbo → OXM → Lg-0.6 → Pbo']}, {'name': 'Placebo for Liraglutide', 'type': 'DRUG', 'description': 'Single subcutaneous dose in the evening of the day before the GGI (Day-1)', 'armGroupLabels': ['Lg-0.6 → OXM → Pbo → Lg-1.2', 'Lg-0.6 → Pbo → OXM → Pbo', 'OXM → Lg-0.6 → Pbo → Lg-1.2', 'OXM → Pbo → Lg-0.6 → Pbo', 'Pbo → Lg-0.6 → OXM → Lg-1.2', 'Pbo → OXM → Lg-0.6 → Pbo']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}