{"protocolSection":{"identificationModule":{"nctId":"NCT02324842","orgStudyIdInfo":{"id":"28431754DIA4009"},"secondaryIdInfos":[{"id":"HSC20140322H","type":"OTHER","domain":"University of Texas Health Science Center- San Antonio"}],"organization":{"fullName":"The University of Texas Health Science Center at San Antonio","class":"OTHER"},"briefTitle":"Effect of Combined Incretin-Based Therapy Plus Canagliflozin on Glycemic Control and the Compensatory Rise in Hepatic Glucose Production in Type 2 Diabetic Patients","officialTitle":"Effect of Combined Incretin-Based Therapy Plus Canagliflozin on Glycemic Control and the Compensatory Rise in Hepatic Glucose Production in Type 2 Diabetic Patients"},"statusModule":{"statusVerifiedDate":"2019-04","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2014-11"},"primaryCompletionDateStruct":{"date":"2018-03-28","type":"ACTUAL"},"completionDateStruct":{"date":"2019-03-31","type":"ACTUAL"},"studyFirstSubmitDate":"2014-11-10","studyFirstSubmitQcDate":"2014-12-18","studyFirstPostDateStruct":{"date":"2014-12-24","type":"ESTIMATED"},"resultsFirstSubmitDate":"2019-03-26","resultsFirstSubmitQcDate":"2019-04-19","resultsFirstPostDateStruct":{"date":"2019-05-14","type":"ACTUAL"},"lastUpdateSubmitDate":"2019-12-10","lastUpdatePostDateStruct":{"date":"2019-12-18","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"The University of Texas Health Science Center at San Antonio","class":"OTHER"},"collaborators":[{"name":"Janssen Scientific Affairs, LLC","class":"INDUSTRY"}]},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"Specific Aim 1.To examine whether the combination of liraglutide plus canagliflozin can prevent the increase in Hepatic Glucose Production (HGP) following institution of canagliflozin therapy and produce an additive or even synergistic effect to lower the plasma glucose concentration and A1c.\n\nSpecific Aim 2: To examine whether combination therapy with liraglutide plus canagliflozin can produce an additive, or even synergistic, effect to promote weight loss and reduction in hepatic and visceral fat content.\n\nSpecific Aim 3. To examine whether combination therapy with liraglutide plus canagliflozin can produce an additive or even synergistic effect to reduce systolic/diastolic blood pressure and 24-hour integrated blood pressure.","detailedDescription":"Specific Aim 1.To examine whether the combination of liraglutide plus canagliflozin can prevent the increase in HGP following institution of canagliflozin therapy and produce an additive or even synergistic effect to lower the plasma glucose concentration and A1c. We will examine this hypothesis by comparing the effect of administration of liraglutide alone, canagliflozin alone, and the combination of liraglutide plus canagliflozin on:(i) the rate of HGP; (ii) decrease in fasting plasma glucose concentration; (iii) counter-regulatory hormone response and (iv) A1c. We anticipate that the addition of liraglutide to canagliflozin will prevent the increase in plasma glucagon concentration, augment insulin secretion, and blunt/block the increase in HGP in response to canagliflozin, resulting in a greater decrease in fasting plasma glucose concentration and A1c than observed with each therapy alone.\n\nSpecific Aim 2: To examine whether combination therapy with liraglutide plus canagliflozin can produce an additive, or even synergistic, effect to promote weight loss and reduction in hepatic and visceral fat content.\n\nSpecific Aim 3. To examine whether combination therapy with liraglutide plus canagliflozin can produce an additive or even synergistic effect to reduce systolic/diastolic blood pressure and 24-hour integrated blood pressure."},"conditionsModule":{"conditions":["Type 2 Diabetes Mellitus"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["NA"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"SINGLE_GROUP","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":45,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Canagliflozin","type":"ACTIVE_COMPARATOR","description":"canagliflozin (film-coated tablet), 100 mg/day, increased to 300 mg/day after week two if tolerated without side effects","interventionNames":["Drug: Canagliflozin"]},{"label":"liraglutide","type":"ACTIVE_COMPARATOR","description":"liraglutide, 1.2 mg/day, increased to 1.8 mg/day after week two if tolerated without side effects","interventionNames":["Drug: Liraglutide"]},{"label":"canagliflozin plus liraglutide","type":"ACTIVE_COMPARATOR","description":"canagliflozin, 100 mg/day, plus liraglutide, 1.2 mg/day, increased to 300 mg/day and 1.8 mg/day, respectively at week two, if tolerated without side effects","interventionNames":["Drug: Canagliflozin","Drug: Liraglutide"]}],"interventions":[{"type":"DRUG","name":"Canagliflozin","description":"Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1)","armGroupLabels":["Canagliflozin","canagliflozin plus liraglutide"],"otherNames":["Invokana"]},{"type":"DRUG","name":"Liraglutide","description":"Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.","armGroupLabels":["canagliflozin plus liraglutide","liraglutide"],"otherNames":["Victoza"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"HbA1c at 4 Months","description":"Primary end point of the study is the HbA1c level in response to canagliflozin alone, liraglutide or canagliflozin with liraglutide.","timeFrame":"Approximately 4 months"},{"measure":"Fasting Plasma Glucose (FPG) at 4 Months","description":"Values will be presented as the mean + (Standard Deviation) SD. The difference in HGP and all secondary endpoints at study end versus baseline will be calculated and compared between each active treatment group with ANOVA.","timeFrame":"Baseline to Approximately 4 months"}],"secondaryOutcomes":[{"measure":"Body Mass Index (BMI) at 4 Months","description":"A measure of BMI at 4 months to examine effects of combination therapy with liraglutide plus canagliflozin.","timeFrame":"Approximately 4 months"}],"otherOutcomes":[{"measure":"Change in Matsuda Index of Insulin Sensitivity, Insulin Secretion, and Beta Cell Function During Oral Glucose Tolerance Test (OGTT)","description":"Values will be presented as the mean + SD. The Matsuda Index is a novel assessment of insulin sensitivity that is simple to calculate and provides a reasonable approximation of whole-body insulin sensitivity from the OGTT. The index is calculated from plasma glucose (mg/dl) and insulin (mIU/l) concentrations in both fasting state and post-OGTT. The index value obtained is compared to normal physiologic values to assess insulin sensitivity or resistance. The higher the number, the more insulin sensitive and the lower the number the more insulin resistant the subjects are. Insulin secretion will be measured from plasma C-peptide concentration during the OGTT and the Mari Model will be used to measure beta cell glucose sensitivity","timeFrame":"Change from Baseline to Approximately 4 months"},{"measure":"Change in Free Plasma Insulin at the End of the Study From Baseline Value","description":"Values will be presented as the mean + SD. The difference in HGP and all secondary endpoints at study end versus baseline will be calculated and compared between each active treatment group with ANOVA.","timeFrame":"At Approximately 4 months"},{"measure":"Change in Plasma Glucagon Concentration at the End of the Study Compared to Baseline","description":"Values will be presented as the mean + SD. The difference in HGP and all secondary endpoints at study end versus baseline will be calculated and compared between each active treatment group with ANOVA.","timeFrame":"Approximately 4 months"},{"measure":"Change in Total Body Weight at Study End Compared to Baseline","description":"Values will be presented as the mean + SD. The difference in HGP and all secondary endpoints at study end versus baseline will be calculated and compared between each active treatment group with ANOVA. The difference between baseline and study end will represent the change in body weight due to change in hepatic, visceral and abdominal subcutaneous fat.","timeFrame":"Approximately 4 months"},{"measure":"Change in 24-hour Blood Pressure at Study End Compared to Baseline.","description":"Values will be presented as the mean + SD. The difference in HGP and all secondary endpoints at study end versus baseline will be calculated and compared between each active treatment group with ANOVA.","timeFrame":"Approximately 4 months"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Male and female subjects between the ages of 18-70\n* Subjects with Type 2 Diabetes Mellitus (T2DM)\n* Drug naïve or on stable dose (more than 3 months) of metformin with or without sulfonylurea\n* Have an HbA1c levels ≥7.0% and \\<10.0%\n* Stable weight (± 3 lbs) over the preceding 3 months\n\nExclusion Criteria:\n\n* Subjects taking drugs known to affect glucose metabolism (other than metformin) will be excluded.\n* Individuals with evidence of proliferative diabetic retinopathy or plasma creatinine \\>1.4 females or \\>1.5 males or estimated Glomerular Filtration Rate (eGFR)\\< 60 ml/min.172m2 will be excluded\n* Unstable body weight (change of greater than ±3 lbs over the preceding 3 months)\n* Participates in excessively heavy exercise program","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"70 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Eugenio Cersosimo, MD","affiliation":"The University of Texas Health Science Center at San Antonio","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"University of Texas Health Science Center at San Antonio","city":"San Antonio","state":"Texas","zip":"78229","country":"United States","geoPoint":{"lat":29.42412,"lon":-98.49363}}]},"referencesModule":{"references":[{"pmid":"32745202","type":"DERIVED","citation":"Ali AM, Mari A, Martinez R, Al-Jobori H, Adams J, Triplitt C, DeFronzo R, Cersosimo E, Abdul-Ghani M. Improved Beta Cell Glucose Sensitivity Plays Predominant Role in the Decrease in HbA1c with Cana and Lira in T2DM. J Clin Endocrinol Metab. 2020 Oct 1;105(10):dgaa494. doi: 10.1210/clinem/dgaa494."},{"pmid":"32220916","type":"DERIVED","citation":"Ali AM, Martinez R, Al-Jobori H, Adams J, Triplitt C, DeFronzo R, Cersosimo E, Abdul-Ghani M. Combination Therapy With Canagliflozin Plus Liraglutide Exerts Additive Effect on Weight Loss, but Not on HbA1c, in Patients With Type 2 Diabetes. Diabetes Care. 2020 Jun;43(6):1234-1241. doi: 10.2337/dc18-2460. Epub 2020 Mar 27."}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Canagliflozin","description":"canagliflozin (film-coated tablet), 100 mg/day, increased to 300 mg/day after week two if tolerated without side effects\n\nCanagliflozin: Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1)"},{"id":"FG001","title":"Liraglutide","description":"liraglutide, 1.2 mg/day, increased to 1.8 mg/day after week two if tolerated without side effects\n\nLiraglutide: Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus."},{"id":"FG002","title":"Canagliflozin Plus Liraglutide","description":"canagliflozin, 100 mg/day, plus liraglutide, 1.2 mg/day, increased to 300 mg/day and 1.8 mg/day, respectively at week two, if tolerated without side effects\n\nCanagliflozin: Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1)\n\nLiraglutide: Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"15"},{"groupId":"FG001","numSubjects":"15"},{"groupId":"FG002","numSubjects":"15"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"14"},{"groupId":"FG001","numSubjects":"14"},{"groupId":"FG002","numSubjects":"13"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"2"}]}],"dropWithdraws":[{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"2"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Canagliflozin","description":"canagliflozin (film-coated tablet), 100 mg/day, increased to 300 mg/day after week two if tolerated without side effects\n\nCanagliflozin: Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1)"},{"id":"BG001","title":"Liraglutide","description":"liraglutide, 1.2 mg/day, increased to 1.8 mg/day after week two if tolerated without side effects\n\nLiraglutide: Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus."},{"id":"BG002","title":"Canagliflozin Plus Liraglutide","description":"canagliflozin, 100 mg/day, plus liraglutide, 1.2 mg/day, increased to 300 mg/day and 1.8 mg/day, respectively at week two, if tolerated without side effects\n\nCanagliflozin: Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1)\n\nLiraglutide: Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus."},{"id":"BG003","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"14"},{"groupId":"BG001","value":"14"},{"groupId":"BG002","value":"13"},{"groupId":"BG003","value":"41"}]}],"measures":[{"title":"Age, Categorical","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"14"},{"groupId":"BG001","value":"14"},{"groupId":"BG002","value":"13"},{"groupId":"BG003","value":"41"}]}],"categories":[{"title":"<=18 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"14"},{"groupId":"BG001","value":"14"},{"groupId":"BG002","value":"13"},{"groupId":"BG003","value":"41"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"14"},{"groupId":"BG001","value":"14"},{"groupId":"BG002","value":"13"},{"groupId":"BG003","value":"41"}]}],"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"6"},{"groupId":"BG002","value":"7"},{"groupId":"BG003","value":"17"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"6"},{"groupId":"BG003","value":"24"}]}]}]},{"title":"Race and Ethnicity Not Collected","populationDescription":"Race and Ethnicity were not collected from any participant.","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]}],"categories":[{"measurements":[{"groupId":"BG003","value":"0"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"14"},{"groupId":"BG001","value":"14"},{"groupId":"BG002","value":"13"},{"groupId":"BG003","value":"41"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"14"},{"groupId":"BG001","value":"14"},{"groupId":"BG002","value":"13"},{"groupId":"BG003","value":"41"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"HbA1c at 4 Months","description":"Primary end point of the study is the HbA1c level in response to canagliflozin alone, liraglutide or canagliflozin with liraglutide.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"percentage glycated hemoglobin","timeFrame":"Approximately 4 months","groups":[{"id":"OG000","title":"Canagliflozin","description":"canagliflozin (film-coated tablet), 100 mg/day, increased to 300 mg/day after week two if tolerated without side effects\n\nCanagliflozin: Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1)"},{"id":"OG001","title":"Liraglutide","description":"liraglutide, 1.2 mg/day, increased to 1.8 mg/day after week two if tolerated without side effects\n\nLiraglutide: Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus."},{"id":"OG002","title":"Canagliflozin Plus Liraglutide","description":"canagliflozin, 100 mg/day, plus liraglutide, 1.2 mg/day, increased to 300 mg/day and 1.8 mg/day, respectively at week two, if tolerated without side effects\n\nCanagliflozin: Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1)\n\nLiraglutide: Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"15"},{"groupId":"OG002","value":"15"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"8.2","spread":"0.3"},{"groupId":"OG001","value":"8.4","spread":"0.3"},{"groupId":"OG002","value":"8.1","spread":"0.3"}]}]}]},{"type":"PRIMARY","title":"Fasting Plasma Glucose (FPG) at 4 Months","description":"Values will be presented as the mean + (Standard Deviation) SD. The difference in HGP and all secondary endpoints at study end versus baseline will be calculated and compared between each active treatment group with ANOVA.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mg/dl","timeFrame":"Baseline to Approximately 4 months","groups":[{"id":"OG000","title":"Canagliflozin","description":"canagliflozin (film-coated tablet), 100 mg/day, increased to 300 mg/day after week two if tolerated without side effects\n\nCanagliflozin: Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1)"},{"id":"OG001","title":"Liraglutide","description":"liraglutide, 1.2 mg/day, increased to 1.8 mg/day after week two if tolerated without side effects\n\nLiraglutide: Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus."},{"id":"OG002","title":"Canagliflozin Plus Liraglutide","description":"canagliflozin, 100 mg/day, plus liraglutide, 1.2 mg/day, increased to 300 mg/day and 1.8 mg/day, respectively at week two, if tolerated without side effects\n\nCanagliflozin: Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1)\n\nLiraglutide: Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"15"},{"groupId":"OG002","value":"15"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"174","spread":"12"},{"groupId":"OG001","value":"177","spread":"10"},{"groupId":"OG002","value":"180","spread":"15"}]}]}]},{"type":"SECONDARY","title":"Body Mass Index (BMI) at 4 Months","description":"A measure of BMI at 4 months to examine effects of combination therapy with liraglutide plus canagliflozin.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"kg/m2","timeFrame":"Approximately 4 months","groups":[{"id":"OG000","title":"Canagliflozin","description":"canagliflozin (film-coated tablet), 100 mg/day, increased to 300 mg/day after week two if tolerated without side effects\n\nCanagliflozin: Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1)"},{"id":"OG001","title":"Liraglutide","description":"liraglutide, 1.2 mg/day, increased to 1.8 mg/day after week two if tolerated without side effects\n\nLiraglutide: Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus."},{"id":"OG002","title":"Canagliflozin Plus Liraglutide","description":"canagliflozin, 100 mg/day, plus liraglutide, 1.2 mg/day, increased to 300 mg/day and 1.8 mg/day, respectively at week two, if tolerated without side effects\n\nCanagliflozin: Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1)\n\nLiraglutide: Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"15"},{"groupId":"OG002","value":"15"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"34.8","spread":"1.7"},{"groupId":"OG001","value":"35.1","spread":"1.1"},{"groupId":"OG002","value":"34.8","spread":"1.1"}]}]}]},{"type":"OTHER_PRE_SPECIFIED","title":"Change in Matsuda Index of Insulin Sensitivity, Insulin Secretion, and Beta Cell Function During Oral Glucose Tolerance Test (OGTT)","description":"Values will be presented as the mean + SD. The Matsuda Index is a novel assessment of insulin sensitivity that is simple to calculate and provides a reasonable approximation of whole-body insulin sensitivity from the OGTT. The index is calculated from plasma glucose (mg/dl) and insulin (mIU/l) concentrations in both fasting state and post-OGTT. The index value obtained is compared to normal physiologic values to assess insulin sensitivity or resistance. The higher the number, the more insulin sensitive and the lower the number the more insulin resistant the subjects are. Insulin secretion will be measured from plasma C-peptide concentration during the OGTT and the Mari Model will be used to measure beta cell glucose sensitivity","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"index value","timeFrame":"Change from Baseline to Approximately 4 months","groups":[{"id":"OG000","title":"Canagliflozin","description":"canagliflozin (film-coated tablet), 100 mg/day, increased to 300 mg/day after week two if tolerated without side effects\n\nCanagliflozin: Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1)"},{"id":"OG001","title":"Liraglutide","description":"liraglutide, 1.2 mg/day, increased to 1.8 mg/day after week two if tolerated without side effects\n\nLiraglutide: Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus."},{"id":"OG002","title":"Canagliflozin Plus Liraglutide","description":"canagliflozin, 100 mg/day, plus liraglutide, 1.2 mg/day, increased to 300 mg/day and 1.8 mg/day, respectively at week two, if tolerated without side effects\n\nCanagliflozin: Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1)\n\nLiraglutide: Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"15"},{"groupId":"OG002","value":"15"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.8","spread":"0.4"},{"groupId":"OG001","value":"-0.5","spread":"0.4"},{"groupId":"OG002","value":"0.1","spread":"0.2"}]}]}]},{"type":"OTHER_PRE_SPECIFIED","title":"Change in Free Plasma Insulin at the End of the Study From Baseline Value","description":"Values will be presented as the mean + SD. The difference in HGP and all secondary endpoints at study end versus baseline will be calculated and compared between each active treatment group with ANOVA.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mg/ml","timeFrame":"At Approximately 4 months","groups":[{"id":"OG000","title":"Canagliflozin","description":"canagliflozin (film-coated tablet), 100 mg/day, increased to 300 mg/day after week two if tolerated without side effects\n\nCanagliflozin: Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1)"},{"id":"OG001","title":"Liraglutide","description":"liraglutide, 1.2 mg/day, increased to 1.8 mg/day after week two if tolerated without side effects\n\nLiraglutide: Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus."},{"id":"OG002","title":"Canagliflozin Plus Liraglutide","description":"canagliflozin, 100 mg/day, plus liraglutide, 1.2 mg/day, increased to 300 mg/day and 1.8 mg/day, respectively at week two, if tolerated without side effects\n\nCanagliflozin: Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1)\n\nLiraglutide: Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"15"},{"groupId":"OG002","value":"15"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2","spread":"2"},{"groupId":"OG001","value":"2","spread":"2"},{"groupId":"OG002","value":"0.7","spread":"1"}]}]}]},{"type":"OTHER_PRE_SPECIFIED","title":"Change in Plasma Glucagon Concentration at the End of the Study Compared to Baseline","description":"Values will be presented as the mean + SD. 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