Logo 1 Logo 2

Clinical Trial Details

Trial ID: L5166
Source ID: NCT02791490
Associated Drug: Sitagliptin
Title: A Study of the Safety and Efficacy of Sitagliptin Addition During Metformin Up-titration (MK-0431-848)
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02791490/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Sitagliptin|DRUG: Placebo|DRUG: Metformin IR
Outcome Measures: Primary: Change From Baseline in Hemoglobin A1C at Week 20, 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. The change from baseline represents the Week 20 A1C value minus the Week 0 (baseline) A1C value., Baseline and Week 20|Percentage of Participants Who Experienced at Least One Adverse Event (AE), An adverse event (AE) is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product., Up to 22 weeks|Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event, An adverse event (AE) is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product., Up to 20 weeks | Secondary: Percentage of Participants With Hemoglobin A1C <7% at Week 20, 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., Week 20|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 20, Plasma glucose was measured on a fasting basis and is expressed as mg/dL. Blood was drawn predose on Day 1 and after 20 weeks of treatment to determine change in FPG levels. The change from baseline represents the Week 20 FPG value minus the Week 0 (baseline) FPG value., Baseline and Week 20|Percentage of Participants With Hemoglobin A1C ≥8.5% at Baseline That Attained A1C Goal of <7% at Week 20, 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 and Week 20|Percentage of Participants Receiving Glycemic Rescue Therapy, Participants who met pre-specified criteria for glycemic rescue received appropriate rescue therapy. The choice of anti-hyperglycemic rescue agent, dose, and regimen was directed by the investigator, as clinically appropriate., Up to 20 weeks
Sponsor/Collaborators: Sponsor: Merck Sharp & Dohme LLC
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 458
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2016-06-16
Completion Date: 2018-02-01
Results First Posted: 2019-02-28
Last Update Posted: 2019-02-28
Locations:
URL: https://clinicaltrials.gov/show/NCT02791490