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Clinical Trial Details

Trial ID: L5142
Source ID: NCT01729403
Associated Drug: Aleglitazar
Title: A Study of The Effect of Aleglitazar on Insulin Sensitivity in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Metformin
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus Type 2
Interventions: DRUG: aleglitazar|DRUG: metformin|DRUG: placebo
Outcome Measures: Primary: Change in whole-body insulin sensitivity as assessed by M-value (Insulin-stimulated glucose disposal rate), from baseline to Week 16 | Secondary: Change in hepatic insulin sensitivity (basal index of hepatic insulin resistance), from baseline to Week 16|Change in parameters of beta cell function (first and second phase insulin secretion), from baseline to Week 16|Change in HbA1c, from baseline to Week 16|Change in lipid profile, from baseline to Week 16|Change in mean 24h blood pressure, from baseline to Week 16|Change in hepatic fat content measured by magnetic resonance spectroscopy (MRI), from baseline to Week 16|Change in fat content/distribution in the abdominal region measured by MRI, from baseline to Week 16|Change in total body fat content measured by air displacement phlethysmography, from baseline to Week 16|Change in homeostatic indexes of insulin sensitivity assessed by Homeostasis Model Assessment for Insulin Sensitivity (HOMA-IS), from baseline to Week 16|Change in markers of cardiovascular risk (high sensitivity C-reactive protein, adiponectin, free fatty acid), from baseline to Week 16|Safety: Incidence of adverse events, 22 weeks
Sponsor/Collaborators: Sponsor: Hoffmann-La Roche
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 57
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2012-12
Completion Date: 2013-09
Results First Posted:
Last Update Posted: 2016-11-02
Locations: Neuss, 41460, Germany
URL: https://clinicaltrials.gov/show/NCT01729403