None listed
Conditions
Interventions
MK-3102 25 mg and matching placebo will be administered in a blinded manner as one capsule once-weekly (q.w.):
- During the 2-week single-blind placebo run-in, all subjects will receive 1 placebo c
Sponsors
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.,
Eligibility
Age
40 Years to 95 Years
Inclusion criteria
Inclusion criteria: • All laboratory measurements are to be performed after an overnight fast ≥10 hours in duration. Subjects with laboratory screening values/findings not meeting protocol inclusion criteria may, at the discretion of the investigator, have one repeat determination performed by the central laboratory. If the repeat value satisfies the criterion they may continue in the screening process. Only laboratory tests not meeting inclusion criteria are to be repeated (not the entire panel). Subjects must meet all of the following criteria to participate in the trial. 1. Subject has T2DM and is ≥40 years of age. 2. Subject is receiving one of the following diabetes treatment regimens and has A1C of ≥7.0% and ≤10.0%. (a) treated by diet and exercise alone (not on AHA for ≥12 weeks) (b) on metformin, a sulfonylurea, a meglitinide, pioglitazone, or an alpha-glucosidase inhibitor as mono- or dual combination therapy continuously for at least 12 weeks (except for pioglitazone for at least 16 weeks) without dose alterations. (c) on a stable insulin regimen with one of the following insulins, alone or in combination with metformin: • intermediate-acting insulin (e.g., NPH); • pre-mixed insulin (e.g., Novolog 70/30®, Novolin 70/30®, Humalog 75/25®, or Humulin 70/30®); or • long-acting insulin (e.g., glargine, detemir, degludec)
Exclusion criteria
Exclusion criteria: • SUBJECT/PATIENT EXCLUSION CRITERIA All laboratory measurements are to be performed after an overnight fast ≥10 hours in duration. Subjects with laboratory screening values/findings meeting protocol exclusion criteria may, at the discretion of the investigator, have one repeat determination performed by the central laboratory. If the repeat value does not meet the criterion, the subject may continue in the screening process. Only laboratory tests meeting exclusion criteria are to be repeated (not the entire panel). Subjects must be excluded if they meet any of the following criteria. At Visit 1/Screening Diabetes Diagnosis and Prior Therapy Criteria 1. Subject has a history of type 1 diabetes mellitus or a history of ketoacidosis. OR Subject is assessed by the investigator as possibly having type 1 diabetes confirmed with a C-peptide <0.7 ng/mL (0.23 nmol/L). Note: Only subjects assessed by the investigator as possibly having type 1 diabetes should have C-peptide measured at Visit 1/Screening. 2. Subject has been treated with rosiglitazone, a DPP-4 inhibitor or a GLP-1 receptor agonist within the prior 12 weeks of Visit 1/Screening. 3. Subject has a history of hypersensitivity to a DPP-4 inhibitor Subjects Requiring Specific Treatments
Countries
Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, Finland, France, Georgia, Germany, Hungary, India, Israel, Italy, Japan, Jordan, Korea North, Korea South, Lebano, Lithuania, Malasya, Mexico, New Zealand, Philippines, Poland, Portugal, Romania, Russian Federation, Singapore, Slovakia, South Africa, Spain, Sweden, Turkey, Ukraine, United Kindgdom, United States
Contacts
Public ContactYNGRID SALDARRIAGA
PAREXEL INTERNATIONAL (PERU) S.A.
Outcome results
None listed