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Clinical Trial Details

Trial ID: L7158
Source ID: NCT02846233
Associated Drug: Glp1 Receptor Agonist
Title: Stepping-down Approach in Patients With Chronic Poorly-controlled Diabetes on Advanced Insulin Therapy?
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02846233/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: GLP1 receptor agonist|DRUG: basal insulin|DRUG: SGLT2 inhibitor|DRUG: Metformin
Outcome Measures: Primary: Change in A1c at the End of Study Period, change in A1c (%) from baseline to end of study at 16 weeks, 16 weeks (from baseline to end of study at 16 weeks) | Secondary: Changes in Weight, change (in pounds) from baseline to the end of study at 16 weeks, 16 weeks (from baseline to end of study at 16 weeks)|Changes in Blood Pressure, change (mmHg) of systolic BP from baseline to the end of study at 16 weeks, 16 weeks (from baseline to end of study at 16 weeks)|Changes in Heart Rate, change (beats/min) from baseline to the end of study at 16 weeks, 16 weeks|Changes in LDL, change (mg/dL) from baseline to the end of study at 16 weeks, 16 weeks (from baseline to end of study at 16 weeks)|Changes in Total Cholesterol, change (mg/dL) from baseline to the end of study at 16 weeks, 16 weeks (from baseline to end of study at 16 weeks)|Changes in Serum Creatinine, change (mg/dL) from baseline to the end of study at 16 weeks, 16 weeks (from baseline to end of study at 16 weeks)|Changes in Treatment Satisfaction Scores (DM-SAT Total Score), Patient satisfaction with treatment in both groups will be measured by the validated the Diabetes Medications Satisfaction Tool (DM-SAT). Response options range from 0="not at all satisfied" to 10="extremely satisfied" and a total score is calculated ranging from 0 to 100, with higher scores indicating more diabetes medication satisfaction., 16 weeks (from baseline to end of study at 16 weeks)
Sponsor/Collaborators: Sponsor: University of California, San Francisco
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 22
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2016-08
Completion Date: 2018-12
Results First Posted: 2020-11-10
Last Update Posted: 2020-11-10
Locations: UCSF Fresno, Fresno, California, 93701, United States
URL: https://clinicaltrials.gov/show/NCT02846233