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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

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-009517-18-ES
Enrollment
241
Registered
2009-02-26
Start date
2009-04-23
Completion date
Unknown
Last updated
2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus Tipo 2 Type 2 Diabetes Mellitus MedDRA version: 9.1 Level: LLT Classification code 10012601 Term: Diabetes mellitus

Interventions

Product Name: MK-3577 Pharmaceutical Form: Capsule* Current Sponsor code: MK-3577 Concentration unit: mg milligram(s) Concentration type

Sponsors

Merck & Co., Inc.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: No treatment with PPAR-gamma agonist (TZDs) or statins within 12 weeks

Design outcomes

Primary

MeasureTime frame
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)—

Countries

Germany, Hungary, Italy, Spain

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026