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Clinical Trial Details

Trial ID: L4344
Source ID: NCT02492763
Associated Drug: Mk-8521
Title: A Preliminary Study of the Efficacy and Safety of MK-8521 for Type 2 Diabetes (MK-8521-004)
Acronym:
Status: TERMINATED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02492763/results
Conditions: Type II Diabetes Mellitus
Interventions: DRUG: MK-8521|DRUG: Placebo|DRUG: Liraglutide|DRUG: Metformin
Outcome Measures: Primary: Change From Baseline in Hemoglobin A1C (A1C) at Week 12, A1C is the percentage of hemoglobin that has glucose bound to it and is a blood marker used to report average blood glucose levels over prolonged periods of time. A1C is reported as a percentage (%). This change from baseline reflects the Week 12 A1C minus the Week 0 A1C., Baseline and Week 12|Number of Participants With an Adverse Event (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 14|Number of Participants Who Discontinued Study Treatment 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 12|Number of Participants With an AE of Symptomatic Hypoglycemia, 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. Hypoglycemia episodes are those with glucose values ≤70 mg/dL (3.9 mmol/L). Symptomatic hypoglycemia episodes were episodes with clinical symptoms reported by the investigator as hypoglycemia and classified as adverse events., Up to Week 14|Change From Baseline in Heart Rate at Week 12, This change from baseline reflects the Week 12 heart rate minus the Week 0 heart rate., Baseline and Week 12 | Secondary: Change From Baseline in Body Weight at Week 12, This change from baseline reflects the Week 12 body weight minus the Week 0 body weight., Baseline and Week 12|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12, This change from baseline reflects the Week 12 FPG minus the Week 0 FPG., Baseline and Week 12|Change From Baseline in Fasting Low Density Lipoprotein (LDL) Cholesterol at Week 12, This change from baseline reflects the Week 12 fasting LDL cholesterol minus the Week 0 fasting LDL cholesterol., Baseline and Week 12|Change From Baseline in Fasting High Density Lipoprotein (HDL) Cholesterol at Week 12, This change from baseline reflects the Week 12 fasting HDL cholesterol minus the Week 0 fasting HDL cholesterol., Baseline and Week 12|Change From Baseline in Fasting Triglycerides at Week 12, This change from baseline reflects the Week 12 fasting triglycerides minus the Week 0 fasting triglycerides., Baseline and Week 12|Change From Baseline in Systolic Blood Pressure (SBP) at Week 12, This change from baseline reflects the Week 12 SBP minus the Week 0 SBP., Baseline and Week 12|Change From Baseline in Diastolic Blood Pressure (DBP) at Week 12, This change from baseline reflects the Week 12 DBP minus the Week 0 DBP., Baseline and Week 12
Sponsor/Collaborators: Sponsor: Merck Sharp & Dohme LLC
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 176
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2015-07-27
Completion Date: 2017-04-18
Results First Posted: 2018-03-08
Last Update Posted: 2018-09-10
Locations:
URL: https://clinicaltrials.gov/show/NCT02492763