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Clinical Trial Details

Trial ID: L6371
Source ID: NCT04938388
Associated Drug: Semaglutide Pill
Title: Comparison of Oral Semaglutide w/ Placebo- Treatment for Latino Adults w/T2 Diabetes Receiving Enhanced Lifestyle Care
Acronym:
Status: TERMINATED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2|Glucose Metabolism Disorders (Including Diabetes Mellitus)
Interventions: DRUG: Semaglutide Pill|DIETARY_SUPPLEMENT: Fresh organic vegetables
Outcome Measures: Primary: HbA1c < 7.0%, proportion of participants achieving an HbA1c \< 7.0% at 50 weeks post-baseline in both groups (OS versus Placebo) with both groups receiving enhanced lifestyle care., At 50 weeks | Secondary: HbA1c, Comparison with baseline (-2 weeks), At 50 weeks|Weight, Comparison with baseline (-2 weeks), At 50 weeks|Waist circumference, Comparison with baseline (-2 weeks), At 50 weeks|Lying and standing blood pressure, Comparison with baseline (-2 weeks), At 50 weeks|Fasting glucose levels, Comparison with baseline (-2 weeks), At 50 weeks|Fasting insulin levels, Comparison with baseline (-2 weeks), At 50 weeks|Calculation of insulin resistance (HOMA-B and HOMA-IR), Comparison with baseline (-2 weeks), At 50 weeks|Lipid Levels, Lipid levels- (total cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides), Comparison with baseline (-2 weeks) and at 50 weeks|Liver Function Test, Liver Function Test (AST, ALT, Albumin), Comparison with baseline (-2 weeks) and at 50 weeks|CGM Time In Range, Comparison of Continuous Glucose Monitoring data collected over weeks 48-49 with baseline of time in range (70-180 mg/dl) using continuous glucose monitoring, Weeks 48-49|Number of Pill Counts, Adherence to prescribed medicines- Number of Pill Counts, Comparison at 4, 8, 22, 34, and 48 weeks|Additional glucose-lowering medication (rescue medication), The need for additional glucose-lowering medication (rescue medication) initiated by the study physician with recording of additional medication by medication name, Comparison at 4, 8, 22, 34, and 48 weeks|Number of participants with treatment-related adverse events assessed by research physician classified according to Good Clinical Practice guidelines, Participants unable to tolerate the treatment medication, Data captured at baseline
Sponsor/Collaborators: Sponsor: Sansum Diabetes Research Institute | Collaborators: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 12
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2022-01-29
Completion Date: 2023-02-16
Results First Posted:
Last Update Posted: 2023-05-25
Locations: Sansum Diabetes Research Institute, Santa Barbara, California, 93105, United States
URL: https://clinicaltrials.gov/show/NCT04938388