Type 2 Diabetes Mellitus MedDRA version: 9.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus
Conditions
Interventions
Product Name: MK-8245
Product Code: MK-8245
Pharmaceutical Form: Capsule*
INN or Proposed INN: MK-8245
Concentration unit: mg milligram(
Sponsors
Merck & Co., Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Patient has type 2 diabetes mellitus (T2DM). •Patient is = 18 and = 65 years of age on day of signing informed consent. •Patient has body mass index (BMI) > 27 kg/m2 and 45 years of age. 5) undergone post surgical bilateral oophorectomy and/or hysterectomy, 6) undergone a bilateral tubal ligation. •Patient has an FPG = 130 mg/dL (7.2 mmol/L) and = 260 mg/dL (14.4 mmol/L). NOTE: If Visit 3 FPG does not meet this criterion AND is not consistent with the patient's recent fasting SBGM values, a single repeat measurement may be performed at the discretion of the Investigator. If the repeat value meets FPG inclusion criterion, patient may continue in the study. •Patient has successfully completed the 24-hour domicile procedures which includes consuming = 50% of each meal based on caloric content. NOTE: If the patient does not meet this inclusion criterion and it is the Investigator's opinion that the patient is likely to meet this criterion during a second attempt, the current visit can be changed to an "unscheduled visit", and the patient can be rescheduled for Visit 4/Day -1 within one week, and be randomized only if the repeat 24-hour domicile procedures are completed successfully. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •History of type 1 diabetes mellitus or a history of ketoacidosis, or patient is assessed by the investigator as possibly having type 1 diabetes confirmed with a C -peptide 160 mm Hg or diastolic > 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. •Has a clinically important hematological disorder (e.g., aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia). •Has a history of malignancy = 5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer. Patient with a history of malignancy > 5 years prior to signing informed consent should have no evidence of disease. •Has a history of macular edema or vitreous hemorrhage. •Has a recent history (i.e., within prior two weeks) of eye infection or another inflammatory condition of the eye or conjunctiva, including uveitis or scleritis. •Has a history of contact lens use within the prior 3 months. •Has dry eye syndrome, or has any condition that may predispose to dry eye condition (e.g., lupus, rheumatoid arthritis, etc.). •Has used medicated eye drops within the prior 4 weeks. •Has exclusionary lab values as described in the protocol. •Is, at the time of signing informed co
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: (1) After 4 weeks of treatment, to assess the effect of MK-8245 compared to placebo on 24-hour Weighted Mean Glucose (24h-WMG) from baseline. (2) After 4 weeks of treatment, to assess the safety and tolerability of MK-8245. ; Secondary Objective: (1) After 4 weeks of treatment, to assess the effect of MK-8245 compared to placebo on change in fasting plasma glucose from baseline. (2) To obtain preliminary plasma pharmacokinetics (e.g. concentration of drug in the plasma at trough [C12hr]) after oral administration of multiple doses of MK-8245 to patients with type 2 diabetes mellitus ;Primary end point(s): 24-hour Weighted Mean Glucose | — |
Countries
Lithuania, Poland
Outcome results
None listed