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Clinical Trial Details

Trial ID: L5153
Source ID: NCT01189890
Associated Drug: Sitagliptin Phosphate
Title: Safety and Efficacy of Sitagliptin Compared With Glimepiride in Elderly Participants With Type 2 Diabetes Mellitus (MK-0431-251)
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01189890/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: sitagliptin phosphate|DRUG: Glimepiride|DRUG: Placebo to Sitagliptin|DRUG: Placebo to Glimepiride
Outcome Measures: Primary: Least Squares (LS) Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 30, Participant whole blood samples were collected at baseline and Week 30 to determine the LS mean HbA1c change from baseline. HbA1c is a measure of the percentage of glycated hemoglobin in the blood and provides an indication of participant blood glucose control in the 2 to 3 months prior to the evaluation., Baseline and Week 30|Number of Participants With an Adverse Event of Symptomatic Hypoglycemia Up to Week 30, Symptomatic hypoglycemia was defined as an episode with clinical symptoms attributed to hypoglycemia, without regard to glucose level. Participants were instructed to complete the Hypoglycemia Assessment Log (HAL) for any symptomatic episodes he or she believed represent hypoglycemia. If a fingerstick glucose was obtained before or shortly (i.e., within a few minutes) after treating, the value was recorded in the HAL. In addition, participants were instructed to record in the HAL any fingerstick glucose values ≤70 mg/dL (≤3.9 mmol/L) regardless of the presence of clinical symptoms., Up to Week 30|Number of Participants Experiencing An Adverse Event (AE), An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of the treatment administered., Up to Week 30|Number of Participants Discontinuing Study Treatment Due to An AE, An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of the treatment administered., Up to Week 30 | Secondary: LS Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 30, Plasma samples were collected from participants after an overnight fast at baseline and Week 30 to determine the mean change from baseline in participant FPG., Baseline and Week 30|Percentage of Participants With HbA1c <7.0% at Week 30, Participant whole blood samples were collected at Week 30 to determine the number of participants achieving HbA1c \<7.0% at Week 30. HbA1c is a measure of the percentage of glycated hemoglobin in the blood and provides an indication of participant blood glucose control in the 2 to 3 months prior to the evaluation., Week 30|Percentage of Participants With HbA1c <6.5% at Week 30, Participant whole blood samples were collected at Week 30 to determine the number of participants achieving HbA1c \<6.5% at Week 30. Hemoglobin A1c is a measure of the percentage of glycated hemoglobin in the blood and provides an indication of participant blood glucose control in the 2 to 3 months prior to the evaluation., Week 30|LS Mean Change From Baseline in Participant Body Weight at Week 30, Participants were only permitted to wear a drape gown and undergarments (no street clothes, no shoes or socks) for this evaluation. Body weight was measured after voiding (to the nearest 0.1 kg) and measurements were collected until 2 consecutive measurements did not differ by more than 0.2 kg from each other. Body weight measurements were evaluated using a standardized, calibrated digital scale and was reported in kilograms (kg) at baseline and Week 30., Baseline and Week 30
Sponsor/Collaborators: Sponsor: Merck Sharp & Dohme LLC
Gender: ALL
Age: OLDER_ADULT
Phases: PHASE3
Enrollment: 480
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2010-08-16
Completion Date: 2012-10-31
Results First Posted: 2013-06-27
Last Update Posted: 2017-06-05
Locations:
URL: https://clinicaltrials.gov/show/NCT01189890