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Clinical Trial Details

Trial ID: L4571
Source ID: NCT01490918
Associated Drug: Acarbose
Title: Study to Evaluate the Efficacy of Acarbose,Metformin,Sitagliptin Combination Treatment in DM Patients
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01490918/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Acarbose|DRUG: Placebo acarbose|DRUG: placebo metformin
Outcome Measures: Primary: The Change of Glycated Hemoglogin(HbA1c) From Baseline to 16 Weeks of Treatment, The change of glycated hemoglogin(HbA1c) from baseline to 16 weeks of treatment between Placebo + Metformin+Sitagliptin and Metformin + Sitagliptin + Acarbose group, baseline, 16 weeks | Secondary: The Change of HbA1c From Baseline to 24 Weeks of Treatment, The change of glycated hemoglogin(HbA1c) from baseline to 24 weeks of treatment between 3 groups, baseline, 24 weeks|The Change of PPG2hr From Baseline to 24 Weeks of Treatment, The change of PPG2hr (post prandia blood glucose 2hr from baseline to 24 weeks of treatment between 3 groups, baseline, 24 weeks|Changes in Glucose During Meal Tolerance Test Between 2 Group(Group 1 vs Group 2),, Change of AUC(area under the curve) of glucose at 16 week from baseline between 2 groups (placebo+metformin + sitagliptin vs acarbose + metformin + sitagliptin), Visit 2(baseline) and Visit 5(16W)|Changes in Insulin During Mixed Meal Tolerance Test Between 2 Group(Group 1 vs Group 2),, Change of AUC(area under the curve) of insulin at 16 week from baseline between 2 groups (placebo+metformin + sitagliptin vs acarbose + metformin + sitagliptin), Visit 2(baseline) and Visit 5(16W)|Change in Active GLP-1 at 0 Minute During Mixed Meal Test Between 2 Groups (Group 1, group2), Change of active GLP-1 at 0 minute during mixed meal test at 16 week from baseline between 2 groups(group1, group2), baseline, 16 week|Change in Active GLP-1 at 120 Minute During Mixed Meal Test Between 2 Groups (Group 1, group2), Change of active GLP-1 at 120 minute during mixed meal test at 16 week from baseline between 2 groups(group1, group2), baseline, 16 week|Changes in Glucagon During Meal Tolerance Test Between 2 Group(Group 1 vs Group 2),, Change of AUC(area under the curve) of glucagon at 16 week from baseline between 2 groups (placebo+metformin + sitagliptin vs acarbose + metformin + sitagliptin), Visit 2(baseline) and Visit 5(16W) | Other: Changes in Mean Glucose During CGMS Between 3 Group, Change of mean glucose of CGMS(continuous glucose monitoring system) data at 16 week from baseline between 3 groups, Visit 2(baseline) and Visit 5(16W)|Changes in Variation of Glucose During CGMS Between 3 Group, Change of standard deviation of CGMS(continuous glucose monitoring system) data at 16 week from baseline between 3 groups (placebo+metformin + sitagliptin vs acarbose + metformin + sitagliptin vs placebo + acarbose + sitagliptin), Visit 2(baseline) and Visit 5(16W)|Changes in MAGE of Glucose During CGMS Between 2 Group(Group 1 vs Group 2),, Change of mean amplitude of glycemic excursion of CGMS(continuous glucose monitoring system) data at 16 week from baseline between 2 groups (placebo+metformin + sitagliptin vs acarbose + metformin + sitagliptin), Visit 2(baseline) and Visit 5(16W)
Sponsor/Collaborators: Sponsor: The Catholic University of Korea | Collaborators: Bayer
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 165
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2012-04
Completion Date: 2014-09
Results First Posted: 2020-08-17
Last Update Posted: 2020-08-17
Locations: MedicalExcellence, Seoul, 137-701, Korea, Republic of
URL: https://clinicaltrials.gov/show/NCT01490918