Type II Diabetes Mellitus MedDRA version: 9.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus
Conditions
Interventions
Product Name: MK-0893
Pharmaceutical Form: Tablet
INN or Proposed INN: MK-0893
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Pharmaceutical form of the placeb
Sponsors
Merck Sharp & Dohme (Sweden) AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patient has T2DM. (2) Patient is >=21 and =7.5% and =7.0% and =7.0% and =150 and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: (1) Patient has a history of type 1 diabetes or ketoacidosis. (2) Patient has been treated with a PPAR-gamma agonist within the past 3 months. (3) Patient has been treated with insulin within the past 10 weeks. (4) Patient has been treated with a GLP-1 mimetic or agonist within the past 10 weeks. (5) Patient has been treated with MK-0893. (6) Patient has a history of intolerance to, hypersensitivity to, or contraindication to the use of metformin or sitagliptin. (7) Patient has a systolic blood pressure of >150 mm Hg or a diastolic blood pressure of >85 mm Hg. (8) Patient has a Body Mass Index =43 kg/m2. (9) Patient is pregnant. (10) Patient has creatinine value of >=1.4 mg/dL (male) or >= 1.3 mg/dL (female). (11) Patient has a creatinine clearance value of 1.5 times ULN. (13) Patient has an AST value >1.5 times ULN. (14) Patient has a Total Bilirubin value > ULN. (15) Patient has a TSH value outside the normal range. (16) Patient has a Triglyceride value >500 mg/dL. (17) Patient has a Hemoglobin value below the normal range. (18) Patient has a QTc interval >480 ms at Visit 2.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: (1) To assess the effect of treatment with MK-0893 in combination with sitagliptin or metformin compared with sitagliptin in combination with metformin on 24-hour weighted mean glucose (WMG) after 4 weeks. (2) To assess the safety and tolerability of MK-0893 in combination with sitagliptin or metformin.;Secondary Objective: (1) To assess the effect of treatment with MK-0893 in combination with metformin or sitagliptin compared with sitagliptin in combination with metformin on fasting plasma glucose (FPG) after 4 weeks. (2) To assess the effect of treatment with MK-0893 in combination with metformin or sitagliptin compared with sitagliptin in combination with metformin on post-prandial glucose (PPG) as measured by 2-hour AUC glucose after 4 weeks. (3) To assess the effect of treatment with MK-0893 in combination with metformin or sitagliptin compared with sitagliptin in combination with metformin on total and active GLP-1 levels after 4 weeks. (4) To assess the effect of treatment with MK-0893 in combination with metformin or sitagliptin compared with sitagliptin in combination with metformin on body weight after 4 weeks.;Primary end point(s): 24-hour Weighted Mean Glucose | — |
Countries
Denmark, France, Germany, Spain, Sweden
Outcome results
None listed