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Clinical Trial Details

Trial ID: L4335
Source ID: NCT02583919
Associated Drug: Isis-Gcgrrx- Dose Level 1
Title: Safety, Tolerability and Efficacy of ISIS-GCGRRx in Patients With Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes
Interventions: DRUG: ISIS-GCGRRx- Dose Level 1|DRUG: ISIS-GCGRRx- Dose Level 2|DRUG: Placebo
Outcome Measures: Primary: Change in HbA1C, Change from Baseline, Week 27 and subsequent timepoints | Secondary: Safety and Tolerability will be assessed by determining the incidence, severity, dose-relationship adverse-effects, and changes in laboratory evaluations within each dose cohort, Safety results in patients dosed with Isis 449884 will be compared with those from patients dosed with placebo, 50 weeks
Sponsor/Collaborators: Sponsor: Ionis Pharmaceuticals, Inc.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 79
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2015-09
Completion Date: 2017-05-11
Results First Posted:
Last Update Posted: 2018-06-25
Locations: Ionis Investigational Site, Greenbrae, California, 94904, United States|Ionis Investigational Site, Huntington Park, California, 90255, United States|Ionis Investigational Site, La Mesa, California, 91942, United States|Ionis Investigational Site, Los Angeles, California, 90057, United States|Isis Investigational Site, Spring Valley, California, 91978, United States|Ionis Investigational Site, Port Orange, Florida, 32127, United States|Ionis Investigational Site, Marietta, Georgia, 30060, United States|Ionis Investigational Site, Oxon Hill, Maryland, 20745, United States|Ionis Investigational Site, New York, New York, 10016, United States|Ionis Investigational Site, Greensboro, North Carolina, 27410, United States|Ionis Investigational Site, Morehead City, North Carolina, 28557, United States|Ionis Investigational Site, Cincinnati, Ohio, 45219, United States|Ionis Investigational Site, Cincinnati, Ohio, 45245, United States|Ionis Investigational Site, Eugene, Oregon, 97404, United States|Ionis Investigational Site, Spartanburg, South Carolina, 29303, United States|Ionis Investigational Site, Houston, Texas, 77036, United States|Ionis Investigational Site, Houston, Texas, 77074, United States|Ionis Investigational Site, Katy, Texas, 77450, United States|Ionis Investigational Site, Olympia, Washington, 98502, United States
URL: https://clinicaltrials.gov/show/NCT02583919