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Clinical Trial Details

Trial ID: L1836
Source ID: NCT01537120
Associated Drug: Vildagliptin
Title: Evaluation of Continuous Glucose Monitoring in Participants With Type 2 Diabetes Mellitus (MK-0000-258 AM2)
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01537120/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Vildagliptin|DRUG: Placebo
Outcome Measures: Primary: 24 Hour Weighted Mean Glucose (WMG) At 2 Weeks, The 24 hour WMG was measured after 2 weeks of placebo treatment, and again after 2 weeks of vildagliptin treatment. Glucose was measured over a 24 hour period by having participants wear two continuous glucose monitors (CGM), which produced an average glucose value approximately every 5 minutes. Using these values, the concentration of glucose was calculated from Area Under the Curve 0-24 hours (AUC 0-24hr), and was expressed as 24 hour WMG., At 2 weeks after Placebo treatment and again at 2 weeks after Vildagliptin treatment | Secondary: Hemoglobin A1C (HbA1C) At 2 Weeks, Blood samples were taken after 2 weeks of placebo treatment, and again after 2 weeks of vildagliptin treatment to measure the percentage of glycated hemoglobin, HbA1C. Units are therefore presented as HbA1c (%)., At 2 weeks after Placebo treatment and again at 2 weeks after Vildagliptin treatment|HbA1C At 12 Weeks, Blood samples were taken after 2 weeks of placebo treatment, and again after 12 weeks of vildagliptin treatment to measure the percentage of glycated hemoglobin, HbA1C. Units are therefore presented as HbA1c (%)., At 2 weeks after Placebo treatment and again at 12 weeks after Vildagliptin treatment
Sponsor/Collaborators: Sponsor: Merck Sharp & Dohme LLC
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 25
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: SINGLE (PARTICIPANT)|Primary Purpose: DIAGNOSTIC
Start Date: 2011-12
Completion Date: 2012-10
Results First Posted: 2013-12-03
Last Update Posted: 2015-08-19
Locations:
URL: https://clinicaltrials.gov/show/NCT01537120