Type 2 Diabetes Mellitus MedDRA version: 12.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus
Conditions
Interventions
Product Name: MK-3102
Product Code: MK-3102
Pharmaceutical Form: Capsule*
Pharmaceutical form of the placebo: Capsule*
Route of administ
Sponsors
MSD Finland Oy
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -For patients not currently on AHA medication: A1C =7.0 and =10.0% -For patients currently on oral AHA medication monotherapy or low dose dual oral combination therapy (except TZDs): A1C =6.5 and =9.0% -BMI >20kg/m2 and 18 kg/m2 and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Patient has a history of type 1 diabetes mellitus or a history of ketoacidosis. -Patient has previously been treated at any time with either an investigational or marketed DPP-4 inhibitor (such as sitagliptin, vildagliptin, alogliptin, or saxagliptin) or a GLP-1 receptor agonist (such as exenatide or liraglutide), or the patient has required insulin therapy within 14 weeks prior to signing informed consent. -Patient is on or likely to require treatment with warfarin or warfarin-like anticoagulants, digoxin, any other medication with a narrow therapeutic index (see Appendix 6.10). -Patient has a medical history of active liver disease (other than non-alcoholic hepatic steatosis), including chronic active hepatitis B or C (assessed by medical history), primary biliary cirrhosis, or symptomatic gallbladder disease. -Patient is HIV positive (as assessed by medical history). -Patient has a diagnosis of CHF (congestive heart failure) with NYHA Class II - IV cardiac status (refer to Appendix 6.1), patient has new or worsening signs or symptoms of coronary heart disease or congestive heart failure within the past 3 months, or had any of the following disorders within the past 3 months: -Acute coronary syndrome (such as MI or unstable angina) -Coronary artery intervention (CABG or PTCA) -Stroke or transient ischemic neurological disorder -Patient has poorly controlled hypertension defined as systolic blood pressure of =160 mm Hg or diastolic blood pressure of =90 mm Hg and blood pressure is not considered likely to be under these limits by Visit 3/Week -2 with an adjustment in antihypertensive medication. -Patient has a history of a seizure disorder or central degenerative neurological disorder. -Patient has a history of chronic muscle disorder, including chronic myopathies or muscular dystrophy. -Patient has severe active peripheral vascular disease (such as manifested by claudication with minimal activity, a non-healing ischemic ulcer, or disease which is likely to require intervention such as with bypass or angioplasty). -Patient has a history of malignancy or clinically important hematological disorder. Exceptions: (1) Patients with adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix may participate; (2) Patients with other malignancies which have been successfully treated >5 years prior to screening, where in the judgment of both the investigator and treating physician, appropriate follow-up has revealed no evidence of recurrence from the time of treatment through the time of screening. However, patients with a history of leukemia, lymphoma, aplastic anemia, myeloproliferative or myelodysplastic diseases, thrombocytopenia, malignant melanoma, or renal cell carcinoma are ineligible for the study regardless of the time since treatment. -Patient has a positive urine pregnancy test. -At Visit 2, Patient has a QTc interval >480 ms for females, and >470 ms for males. -At Visit 4, Patient has a site-fasting-fingerstick glucose (FFSG) 260 mg/dL (>14.4 mmol/L).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: After 12 weeks, to assess the effect of treatment with MK-3102 compared with placebo on A1C.;Secondary Objective: After 12 weeks, to assess the effect of treatment with MK-3102 compared with placebo on 2-hour Post Meal Glucose (PMG) and FPG;Primary end point(s): A1C, 2-hour Post Meal Glucose (PMG), FPG, | — |
Countries
Denmark, Finland, France, Germany, Hungary, Latvia, Lithuania, Spain
Outcome results
None listed