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Clinical Trial Details

Trial ID: L6767
Source ID: NCT01760447
Associated Drug: Sitagliptin Plus Metformin
Title: A Pooled Analysis of the Safety and Efficacy of MK-0431A and MK-0431A XR in Pediatric Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Therapy (Alone or in Combination With Insulin) (MK-0431A-170/MK-0431A-289)
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01760447/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Sitagliptin plus metformin|DRUG: Placebo to metformin|DRUG: Metformin|DRUG: Placebo to sitagliptin plus metformin|DRUG: Sitagliptin plus metformin XR|DRUG: Placebo to metformin XR|DRUG: Insulin|DRUG: Placebo to sitagliptin plus metformin XR|DRUG: Metformin XR
Outcome Measures: Primary: Change From Baseline in A1C at Week 20, Glycated hemoglobin (A1C) is a blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Mean change from baseline at Week 20 was estimated from a longitudinal data analysis model., Baseline and Week 20|Number of Participants Who Experienced ≥1 Adverse Event During Weeks 0-20, The number of participants experiencing ≥1 adverse event during Weeks 0-20 was reported. An adverse event is defined as any untoward medical occurrence in a person administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment., Up to Week 20|Number of Participants Who Discontinued Study Drug Due to Experiencing an Adverse Event During Weeks 0-20, The number of participants who discontinued from study drug due to an adverse event during Weeks 0-20 was reported. An adverse event is defined as any untoward medical occurrence in a person administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment., Up to Week 20|Number of Participants Who Experienced ≥1 Adverse Event During Weeks 0-56, The number of participants experiencing ≥1 adverse event during Weeks 0-56 were reported. An adverse event is defined as any untoward medical occurrence in a person administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment., Up to approximately Week 56|Number of Participants Who Discontinued Study Drug Due to Experiencing an Adverse Event During Weeks 0-54, The number of participants who discontinued from study drug due to an adverse event during Weeks 0-54 was reported. An adverse event is defined as any untoward medical occurrence in a person administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment., Up to Week 54 | Secondary: Change From Baseline in A1C at Week 54, A1C is a blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Mean change from baseline at Week 54 was estimated from a longitudinal data analysis model., Baseline and Week 54|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 20, Blood glucose was measured on a fasting basis. Mean change from baseline at Week 20 was estimated from a longitudinal data analysis model., Baseline and Week 20|Change From Baseline in FPG at Week 54, Blood glucose was measured on a fasting basis. Mean change from baseline at Week 54 was estimated from a longitudinal data analysis model., Baseline and Week 54|Percentage of Participants With A1C at Goal (<7.0%) at Week 20, Glycated hemoglobin (A1C) is a blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Percentage of participants with A1C at goal (\<7.0%) at Week 20 was presented., Week 20|Percentage of Participants With A1C at Goal (<6.5%) at Week 20, Glycated hemoglobin (A1C) is a blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Percentage of participants with A1C at goal (\<6.5%) at Week 20 was presented., Week 20|Percentage of Participants With A1C at Goal (<7.0%) at Week 54, Glycated hemoglobin (A1C) is a blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Percentage of participants with A1C at goal (\<7.0%) at Week 54 was presented., Week 54|Percentage of Participants With A1C at Goal (<6.5%) at Week 54, Glycated hemoglobin (A1C) is a blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Percentage of participants with A1C at goal (\<6.5%) at Week 54 was presented., Week 54|Percentage of Participants Initiating Glycemic Rescue Therapy by Week 20, Percentage of participants who initiated glycemic rescue therapy prior to Week 20 was reported., Up to Week 20|Percentage of Participants Initiating Insulin Glargine During Weeks 20-54, Percentage of participants who initiated insulin glargine therapy from Weeks 20 through 54 was reported., Week 20 up to Week 54 | Other: Baseline A1C, Glycated hemoglobin (A1C) is a blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100., Baseline
Sponsor/Collaborators: Sponsor: Merck Sharp & Dohme LLC
Gender: ALL
Age: CHILD
Phases: PHASE3
Enrollment: 223
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2011-12-07
Completion Date: 2019-09-17
Results First Posted: 2020-10-05
Last Update Posted: 2022-09-23
Locations:
URL: https://clinicaltrials.gov/show/NCT01760447