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Clinical Trial Details

Trial ID: L5236
Source ID: NCT01582243
Associated Drug: Vildagliptin
Title: Safety and Efficacy of Vildagliptin Plus Metformin (SPC) Treatment in Type 2 Diabetes Mellitus Patients
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01582243/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Vildagliptin
Outcome Measures: Primary: Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24, HbA1c analysis will be performed on a blood sample obtained by study personnel., Baseline, Week 24 | Secondary: Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12, HbA1c analysis will be performed on a blood sample obtained by study personnel., Baseline, week 12|Mean Change From Baseline in Fasting Plasma Glucose(FPG) at Week 12 and 24, FPG analysis will be performed on a blood sample obtained by study personnel., Baseline, week 12, week 24|Mean Change From Baseline in Postprandial Plasma Glucose(PPG) at Week 12 and 24, PPG analysis will be performed on a blood sample obtained by study personnel., Baseline, week, week 24|Mean Change From Baseline in Mean Amplitude of Glycemic Excursions (MAGE) Detected by Continuous Glucose Monitoring System (CGMS) After 24-week, Mean amplitude of glycemic excursions (MAGE), which was used to quantify major swings of glycaemia and assess intra-day glycemic variability, was measured by inserting continuous glucose monitoring system (CGMS) in patients for 72 consecutive hours before Day 1 (Visit 2) and Week 24 (Visit 5). In order to unify the different initial time and time of completion in each patient, only the data recorded from Day 2 00:00 to Day 3 23:59 with total 48 hours were analyzed., Baseline, week 24|The Percentage of Patients Achieving the Two Glycemic Goals After 12- and 24-week Treatment, Patients reaching glycemic goal of HbA1c ≤ 6.5% and ≤ 7.0% at week 12 and 24 will be calculated respectively., week 12, week 24
Sponsor/Collaborators: Sponsor: Novartis Pharmaceuticals
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 40
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2013-04
Completion Date: 2015-09
Results First Posted: 2016-11-03
Last Update Posted: 2016-11-03
Locations: Novartis Investigative Site, Changhua, 500, Taiwan
URL: https://clinicaltrials.gov/show/NCT01582243