A Phase IIa, Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Study the Efficacy and Safety of MK-0893 in Combination With Sitagliptin or in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control. Ensayo clínico en fase IIa, multicéntrico, doble ciego, aleatorizado, controlado con comparador activo para evaluar la eficacia y la seguridad de MK 0893 en combinación con sitagliptina o en combinación con metformina en pacientes con diabetes mellitus de tipo 2 que presentan un control insuficiente de la glucemia.
- Conditions
- Type II Diabetes Mellitus Diabetes Mellitus Tipo IIMedDRA version: 9.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus
- Registration Number
- EUCTR2007-006074-28-ES
- Lead Sponsor
- Merck Sharp & Dohme de España, S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 126
(1) Patient has T2DM.
(2) Patient is >=21 and <=65 years of age.
(3) Patient is either not on oral antihyperglycemic (AHA) medications or insulin for at least 10 weeks with an HbA1c of >=7.5% and <=12.0%, or on a single AHA with an HbA1c of >=7.0% and <=10.0%, or on a low dose combination AHA with an HbA1c of >=7.0% and <=10.0%.
(4) Patient has an FPG of >=150 and <=320 mg/dL at Visit 3/Week -2.
(5) Patient has a site fasting fingerstick glucose of <=320 mg/dL at randomization (Visit 4).
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
(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 <20 kg/m2 or >=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 <60 mL/min.
(12) Patient has an ALT value >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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method