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Clinical Trial Details

Trial ID: L6676
Source ID: NCT02009488
Associated Drug: Canagliflozin, 100 Mg
Title: Treatment Differences Between Canagliflozin and Placebo in Insulin Secretion in Subjects With Type 2 Diabetes Mellitus (T2DM)
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Canagliflozin, 100 mg|DRUG: Canagliflozin, 300 mg|DRUG: Placebo
Outcome Measures: Primary: Change from baseline in hepatic insulin sensitivity, Baseline, 25 weeks|Change from baseline in peripheral tissue insulin sensitivity, Baseline, 25 weeks|Change from baseline in liver fat content, determined using magnetic resonance spectroscopy (MRS), Baseline, 25 weeks|Change from baseline in insulin secretion rate (ISR) during mixed-meal tolerance test (MMTT), Baseline, 25 weeks|Change from baseline in beta-cell glucose sensitivity, determined as a slope of ISR vs. plasma glucose concentration during MMTT, Baseline, 25 weeks | Secondary: Changes from baseline in substrate oxidation and energy production rates during MMTT and euglycemic clamp, Baseline, 25 weeks|Changes from baseline in insulin clearance during MMTT and euglycemic clamp, Baseline, 25 weeks|Change from baseline in suppression of free fatty acids (FFAs) during euglycemic clamp, Baseline, 25 weeks|Changes from baseline in basal and postprandial plasma glucagon, FFAs and β-hydroxybutyrate during MMTT, Baseline, 25 weeks|Change from baseline in renal threshold for glucose (RTG), estimated using an MMTT-based method, Baseline, 25 weeks
Sponsor/Collaborators: Sponsor: Janssen Research & Development, LLC
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 59
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: TREATMENT
Start Date: 2014-09-08
Completion Date: 2017-01-03
Results First Posted:
Last Update Posted: 2018-01-04
Locations: San Diego, La Jolla, California, United States|Gainesville, Florida, United States
URL: https://clinicaltrials.gov/show/NCT02009488