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Clinical Trial Details

Trial ID: L4914
Source ID: NCT02299050
Associated Drug: Cycloset
Title: Effect of Cycloset on Glycemic Control When Added to Glucagon-like Peptide 1 (GLP-1) Analogue Therapy
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02299050/results
Conditions: Type 2 Diabetes
Interventions: DRUG: Cycloset
Outcome Measures: Primary: HbA1C, The objective of this study is to examine the effect of the addition of Cycloset on glycemic control in inadequately controlled (HbA1c 7.5-10.0) T2DM (type 2 diabetes mellitus) patients who are already on Bydureon (exenatide once weekly) or Victoza (liraglutide ) as part of their standard care. An additional co-primary objective of the study is to examine the effect of Cycloset on postprandial glucose metabolism., Change from baseline to four to five months|Glucose Metabolism During Mixed Meal Tolerance Test, The objective of this study is to examine the effect of the addition of Cycloset on glycemic control in inadequately controlled (HbA1c 7.5-10.0) T2DM patients who are already on Bydureon (exenatide once weekly) or Victoza (liraglutide ) as part of their standard care., Change from baseline to four to five months | Secondary: Endothelial Function,, To assess the potential beneficial effect of Cycloset on endothelial function. This is measured by using pulse pressure., Change from baseline to four to five months|Body Composition, To assess the potential beneficial effect of Cycloset on body weight composition., Change from baseline to four to five months|Percentage Body Fat, To assess the potential beneficial effect of Cycloset on body fat content, Change from baseline to four to five months|Blood Pressure, To assess the potential beneficial effect of Cycloset on blood pressure., Change from baseline to four to five months|Mean Arterial Blood Pressure, To assess the potential beneficial effect of Cycloset on change in mean arterial blood pressure, Change from baseline to four to five months|Arterial Stiffness (AS), To assess the potential beneficial effect of Cycloset on arterial stiffness. Arterial stiffness is calculated by the measurement of pulse pressure, where Pulse pressure = SBP - DBP (Where SBP is systolic blood pressure and DBP is diastolic blood pressure) The calculated value is used as a predictor of cardiovascular disease. Higher values indicate that cardiovascular disease is more likely., Change from baseline to four to five months
Sponsor/Collaborators: Sponsor: The University of Texas Health Science Center at San Antonio | Collaborators: VeroScience
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 23
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2014-06
Completion Date: 2018-04-30
Results First Posted: 2019-06-21
Last Update Posted: 2019-06-21
Locations: University of Texas Health Science Center, San Antonio, Texas, 78229, United States
URL: https://clinicaltrials.gov/show/NCT02299050