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Clinical Trial Details

Trial ID: L6883
Source ID: NCT01590797
Associated Drug: Sitagliptin
Title: A Study in China Evaluating the Safety and Efficacy of Adding Sitagliptin to Stable Therapy With Insulin With or Without Metformin in Participants With Type 2 Diabetes Mellitus (T2DM) (MK-0431-254)
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01590797/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Sitagliptin|DRUG: Placebo|BIOLOGICAL: Insulin|DRUG: Metformin
Outcome Measures: Primary: Change From Baseline in Hemoglobin A1C (HbA1C) Levels at Week 24 in Participants Receiving Insulin Alone or in Combination With Metformin, Baseline and Week 24|Number of Participants With One or More Adverse Events, An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study., Up to Week 26|Number of Participants Discontinuing Study Medication Due to an AE, An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study., Up to Week 24 | Secondary: Change From Baseline in HbA1C Levels at Week 24 in Participants Receiving Insulin in Combination With Metformin, Baseline and Week 24|Change From Baseline in 2-Hour Post Meal Glucose Levels at Week 24 in Participants Receiving Insulin Alone or in Combination With Metformin, Baseline and Week 24
Sponsor/Collaborators: Sponsor: Merck Sharp & Dohme LLC
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 467
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2012-07-10
Completion Date: 2014-06-25
Results First Posted: 2015-01-27
Last Update Posted: 2018-08-17
Locations:
URL: https://clinicaltrials.gov/show/NCT01590797