{"protocolSection":{"identificationModule":{"nctId":"NCT00620282","orgStudyIdInfo":{"id":"NN2211-1799"},"organization":{"fullName":"Novo Nordisk A/S","class":"INDUSTRY"},"briefTitle":"The Effect of Liraglutide on Endothelial Function in Subjects With Type 2 Diabetes Mellitus","officialTitle":"The Effect of Liraglutide on Endothelial Function in Subjects With Type 2 Diabetes Mellitus: A 12-week Randomized, Double-blind, Placebo-controlled, Parallel-group, Single-center Trial With an Open-label Glimepiride Arm"},"statusModule":{"statusVerifiedDate":"2017-01","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2008-02"},"primaryCompletionDateStruct":{"date":"2010-05","type":"ACTUAL"},"completionDateStruct":{"date":"2010-05","type":"ACTUAL"},"studyFirstSubmitDate":"2008-02-11","studyFirstSubmitQcDate":"2008-02-20","studyFirstPostDateStruct":{"date":"2008-02-21","type":"ESTIMATED"},"resultsFirstSubmitDate":"2011-05-19","resultsFirstSubmitQcDate":"2011-05-19","resultsFirstPostDateStruct":{"date":"2011-06-15","type":"ESTIMATED"},"lastUpdateSubmitDate":"2017-01-25","lastUpdatePostDateStruct":{"date":"2017-03-08","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Novo Nordisk A/S","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"This trial is conducted in the United States of America (USA). The purpose of the trial is to assess the effect of liraglutide on forearm blood flow in subjects with type 2 diabetes who are on diet and lifestyle changes or treated with metformin alone."},"conditionsModule":{"conditions":["Diabetes","Diabetes Mellitus, Type 2"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":49,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Lira 1.8","type":"EXPERIMENTAL","description":"Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)","interventionNames":["Drug: liraglutide"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)","interventionNames":["Drug: placebo"]},{"label":"Glimepiride","type":"ACTIVE_COMPARATOR","description":"Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12","interventionNames":["Drug: glimepiride"]}],"interventions":[{"type":"DRUG","name":"liraglutide","description":"Stepwise dose increase, s.c. (under the skin) injection, once daily","armGroupLabels":["Lira 1.8"]},{"type":"DRUG","name":"placebo","description":"Liraglutide placebo, stepwise dose increase, s.c. (under the skin) injection, once daily","armGroupLabels":["Placebo"]},{"type":"DRUG","name":"glimepiride","description":"Tablets, 1 - 4 mg daily","armGroupLabels":["Glimepiride"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change in Acetylcholine (ACh)-Mediated Forearm Blood Flow (FBF)","description":"Assessed endothelial function by measuring the change in ACh-mediated FBF at euglycemia (90 mg/dL) using forearm venous occlusion plethysmography (VOP) technique. Unit of Measure refers to volume of blood (mL) per 100 mL of forearm tissue per minute.","timeFrame":"week 0, week 12"}],"secondaryOutcomes":[{"measure":"Change in Sodium Nitroprusside (SNP)-Mediated Forearm Blood Flow (FBF)","description":"Assessed endothelial function by measuring the change in SNP-mediated FBF at euglycemia (90 mg/dL) using forearm venous occlusion plethysmography (VOP) technique. Unit of Measure refers to volume of blood (mL) per 100 mL of forearm tissue per minute.","timeFrame":"week 0, week 12"},{"measure":"Change in HbA1c (Glycosylated Haemoglobin A1c)","description":"Percentage point change in HbA1c","timeFrame":"week 0, week 12"},{"measure":"Change in Fasting Plasma Glucose (FPG)","description":"Change in FPG","timeFrame":"week 0, week 12"},{"measure":"Change in Mean Postprandial Glucose (PPG) Based on Self-measured 7-point Plasma Glucose Profiles","description":"The 7-point profile included plasma glucose measurements at the following time points: before each main meal (breakfast, lunch and dinner), 90 minutes after the start of each main meal (breakfast, lunch and dinner) and at bedtime.","timeFrame":"week 0, week 12"},{"measure":"Change in Body Weight","timeFrame":"week 0, week 12"},{"measure":"Fasting Lipid Profile - Change in Total Cholesterol (TC)","description":"Change in TC","timeFrame":"week 0, week 12"},{"measure":"Fasting Lipid Profile - Change in LDL-C","description":"Change in LDL-C","timeFrame":"week 0, week 12"},{"measure":"Fasting Lipid Profile - Change in HDL-C","description":"Change in HDL-C","timeFrame":"week 0, week 12"},{"measure":"Fasting Lipid Profile - Change in Triglycerides (TG)","description":"Change in TG","timeFrame":"week 0, week 12"},{"measure":"Biomarkers of Cardiovascular Risk - Change in TNF-alpha","description":"Change in TNF-alpha","timeFrame":"week 0, week 12"},{"measure":"Haematology and Biochemistry Tests - Number of Subjects With Blood Urea Nitrogen (BUN) Values Outside Reference Range","description":"Number of subjects with serum BUN values outside reference range at Week 0 and Week 12, respectively. Reference range: Female (lower value 6.000 mg/dL, upper value 21.000 mg/dL) Male (lower value 8.000 mg/dL, upper value 25.000 mg/dL).","timeFrame":"week 0, week 12"},{"measure":"Haematology and Biochemistry Tests - Number of Subjects With Creatinine Values Outside Reference Range","description":"Number of subjects with serum creatinine values outside reference range at Week 0 and Week 12, respectively. Reference range: Female (lower value 0.600 mg/dL, upper value 1.100 mg/dL) Male (lower value 0.800 mg/dL, upper value 1.300 mg/dL).","timeFrame":"week 0, week 12"},{"measure":"Number of Hypoglycaemic Episodes","description":"Total number of hypoglycaemic episodes occurring from week 0 to week 12. Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself and either plasma glucose was below 56 mg/dL or symptoms were reversed after food intake or glucagon/intravenous glucose administration. Minor if subject was able to treat her/himself and plasma glucose was below 56 mg/dL. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 56 mg/dL.","timeFrame":"weeks 0-12"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Type 2 diabetes\n* Diet and lifestyle changes or metformin monotherapy for at least three months\n* HbA1c (glycosylated haemoglobin) 6.5-9.0% (both inclusive)\n* Body Mass Index (BMI) less than or equal to 40 kg/m\\^2\n\nExclusion Criteria:\n\n* Previous treatment with insulin (except for short term treatment with insulin in connection with intercurrent illness, at the discretion of the Investigator)\n* Previous treatment with glucagon-like peptide-1 (GLP-1) analogues/mimetics, including treatment in a clinical trial\n* Treatment with any oral hypoglycaemic agents other than metformin in a period of 3 months prior to screening\n* Current smoker or history of smoking within 6 months prior to screening\n* Evidence of overt cardiovascular disease (documented coronary heart disease, class II-IV congestive heart failure, cerebrovascular disease, or peripheral vascular disease)\n* Abnormal, clinically significant exercise stress electrocardiogram (ECG) test, as judged by the Investigator\n* Known retinopathy or maculopathy requiring acute treatment, as judged by the Investigator\n* Known autonomic neuropathy, as judged by the Investigator\n* Initiation or change (dose or treatment regimen) in concomitant blood pressure-lowering or lipid-lowering medication within 4 weeks prior to screening\n* Systolic blood pressure more than or equal to 140 mmHg and/or diastolic blood pressure more than or equal to 90 mmHg","healthyVolunteers":false,"sex":"ALL","minimumAge":"40 Years","maximumAge":"70 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Global Clinical Registry (GCR, 1452)","affiliation":"Novo Nordisk A/S","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Novo Nordisk Investigational Site","city":"Rochester","state":"Minnesota","zip":"55905","country":"United States","geoPoint":{"lat":44.02163,"lon":-92.4699}}]},"referencesModule":{"references":[{"pmid":"23010561","type":"RESULT","citation":"Alves C, Batel-Marques F, Macedo AF. A meta-analysis of serious adverse events reported with exenatide and liraglutide: acute pancreatitis and cancer. Diabetes Res Clin Pract. 2012 Nov;98(2):271-84. doi: 10.1016/j.diabres.2012.09.008. Epub 2012 Sep 23."},{"pmid":"25212693","type":"RESULT","citation":"Nandy D, Johnson C, Basu R, Joyner M, Brett J, Svendsen CB, Basu A. The effect of liraglutide on endothelial function in patients with type 2 diabetes. Diab Vasc Dis Res. 2014 Nov;11(6):419-30. doi: 10.1177/1479164114547358. Epub 2014 Sep 11."},{"pmid":"25504028","type":"RESULT","citation":"Jensen TM, Saha K, Steinberg WM. Is there a link between liraglutide and pancreatitis? A post hoc review of pooled and patient-level data from completed liraglutide type 2 diabetes clinical trials. Diabetes Care. 2015 Jun;38(6):1058-66. doi: 10.2337/dc13-1210. Epub 2014 Dec 12."}],"seeAlsoLinks":[{"label":"Clinical Trials at Novo Nordisk","url":"http://novonordisk-trials.com"}]}},"resultsSection":{"participantFlowModule":{"recruitmentDetails":"The trial was conducted at one site in the United States of America (USA).","groups":[{"id":"FG000","title":"Lira 1.8","description":"Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)"},{"id":"FG001","title":"Placebo","description":"Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)"},{"id":"FG002","title":"Glimepiride","description":"Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"16"},{"groupId":"FG001","numSubjects":"16"},{"groupId":"FG002","numSubjects":"17"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"16"},{"groupId":"FG001","numSubjects":"14"},{"groupId":"FG002","numSubjects":"16"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"1"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"Arterial line unable to be placed","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Lira 1.8","description":"Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)"},{"id":"BG001","title":"Placebo","description":"Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)"},{"id":"BG002","title":"Glimepiride","description":"Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12"},{"id":"BG003","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"16"},{"groupId":"BG001","value":"16"},{"groupId":"BG002","value":"17"},{"groupId":"BG003","value":"49"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"57.7","spread":"9.0"},{"groupId":"BG001","value":"60.3","spread":"7.3"},{"groupId":"BG002","value":"57.7","spread":"5.3"},{"groupId":"BG003","value":"58.5","spread":"7.3"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"6"},{"groupId":"BG002","value":"6"},{"groupId":"BG003","value":"18"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"10"},{"groupId":"BG002","value":"11"},{"groupId":"BG003","value":"31"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"16"},{"groupId":"BG001","value":"16"},{"groupId":"BG002","value":"17"},{"groupId":"BG003","value":"49"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"16"},{"groupId":"BG001","value":"16"},{"groupId":"BG002","value":"17"},{"groupId":"BG003","value":"49"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]}]}]},{"title":"Duration of Diabetes","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"5.3","spread":"4.1"},{"groupId":"BG001","value":"8.4","spread":"4.6"},{"groupId":"BG002","value":"6.8","spread":"8.1"},{"groupId":"BG003","value":"6.8","spread":"6.0"}]}]}]},{"title":"Previous Anti-diabetic Treatment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"Diet/Exercise","categories":[{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"5"}]}]},{"title":"Metformin","categories":[{"measurements":[{"groupId":"BG000","value":"14"},{"groupId":"BG001","value":"15"},{"groupId":"BG002","value":"15"},{"groupId":"BG003","value":"44"}]}]}]},{"title":"Body Mass Index (BMI)","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"kg/m^2","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"32.7","spread":"4.5"},{"groupId":"BG001","value":"31.6","spread":"4.2"},{"groupId":"BG002","value":"31.1","spread":"4.9"},{"groupId":"BG003","value":"31.8","spread":"4.5"}]}]}]},{"title":"Body Weight","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"kg","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"95.09","spread":"13.12"},{"groupId":"BG001","value":"90.63","spread":"13.47"},{"groupId":"BG002","value":"91.99","spread":"13.97"},{"groupId":"BG003","value":"92.56","spread":"13.38"}]}]}]},{"title":"Glycosylated Haemoglobin A1c (HbA1c)","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"percentage of total haemoglobin","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"7.2","spread":"0.5"},{"groupId":"BG001","value":"7.0","spread":"0.5"},{"groupId":"BG002","value":"7.3","spread":"0.5"},{"groupId":"BG003","value":"7.2","spread":"0.5"}]}]}]},{"title":"Fasting Plasma Glucose (FPG)","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"mg/dL","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"160.8","spread":"31.2"},{"groupId":"BG001","value":"145.2","spread":"20.1"},{"groupId":"BG002","value":"163.3","spread":"33.3"},{"groupId":"BG003","value":"156.6","spread":"29.4"}]}]}]},{"title":"Total Cholesterol (TC)","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"mg/dL","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"170.2","spread":"34.4"},{"groupId":"BG001","value":"157.5","spread":"32.0"},{"groupId":"BG002","value":"160.2","spread":"24.1"},{"groupId":"BG003","value":"162.6","spread":"30.2"}]}]}]},{"title":"Low density lipoprotein (LDL-C)","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"mg/dL","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"102.8","spread":"31.3"},{"groupId":"BG001","value":"92.5","spread":"23.5"},{"groupId":"BG002","value":"94.1","spread":"18.4"},{"groupId":"BG003","value":"96.4","spread":"24.8"}]}]}]},{"title":"High density lipoprotein (HDL-C)","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"mg/dL","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"39.6","spread":"10.0"},{"groupId":"BG001","value":"39.2","spread":"7.5"},{"groupId":"BG002","value":"43.5","spread":"10.3"},{"groupId":"BG003","value":"40.8","spread":"9.4"}]}]}]},{"title":"Triglycerides (TG)","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"mg/dL","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"165.8","spread":"72.9"},{"groupId":"BG001","value":"145.9","spread":"57.5"},{"groupId":"BG002","value":"141.4","spread":"67.4"},{"groupId":"BG003","value":"150.8","spread":"65.7"}]}]}]},{"title":"Tumor necrosis factor-alpha (TNF-alpha)","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"pg/mL","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"2.1","spread":"1.5"},{"groupId":"BG001","value":"1.4","spread":"0.8"},{"groupId":"BG002","value":"1.4","spread":"0.5"},{"groupId":"BG003","value":"1.6","spread":"1.0"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change in Acetylcholine (ACh)-Mediated Forearm Blood Flow (FBF)","description":"Assessed endothelial function by measuring the change in ACh-mediated FBF at euglycemia (90 mg/dL) using forearm venous occlusion plethysmography (VOP) technique. 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