Ensayo clínico de fase IIa, multicéntrico, aleatorizado, controlado con placebo y con tratamiento activo, cruzado para estudiar la seguridad y la eficacia de MK-3577 en pacientes con diabetes mellitus de tipo 2 con control insuficiente de la glucemia. A Phase IIa, Multicenter, Randomized, Placebo- and Active-Comparator Controlled, Cross-Over Clinical Trial to Study the Safety and Efficacy of MK-3577 in Patients with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
Phase 1
- Conditions
- Diabetes Mellitus Tipo 2 Type 2 Diabetes MellitusMedDRA version: 9.1 Level: LLT Classification code 10012601 Term: Diabetes mellitus
- Registration Number
- EUCTR2009-009517-18-ES
- Lead Sponsor
- Merck & Co., Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 241
Inclusion Criteria
T2DM patients aged 18-70 years who are either drug naïve (AIC range of 6.5-9.5%) or on oral AHA monotherapy or low-dose combination therapy (AIC range of 6.0-9.0%)
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) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
No treatment with PPAR-gamma agonist (TZDs) or statins within 12 weeks
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the 24-hour weighted mean glucose (WMG)-lowering efficacy, safety and tolerability of MK-3577;Secondary Objective: To assess the effect of morning and/or evening administration of MK-3577 on fasting glucose levels, 2-hour postprandial glucose levels after the morning meal and LDL-C;Primary end point(s): 24-hour Weighted Mean Glucose (WMG)
- Secondary Outcome Measures
Name Time Method