STUDY A - STUDY, RANDOMIZED, DOUBLE CIENGO TO EVALUATE THE SAFETY AND EFFICACY OF MONOTHERAPY WITH MK-0767 IN PATIENTS WITH DIABETES MELLITUS TYPE 2.

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

REPEC

Registry ID

PER-066-03

Enrollment

Registered

2003-12-02

Start date

Unknown

Completion date

Unknown

Last updated

2023-09-04

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

Conditions

None listed

Interventions

Placebo Type of group

It will be supplied with placebo of MK-0767 Group name:5 mg MK-0767 Type of group

5 mg MK-0767 will be supplied

Eligibility

Inclusion criteria

Inclusion criteria: Men and women not pregnant. Between> 21 and 7.0% and <10.5%.

Exclusion criteria

Exclusion criteria: Pacientes con antecedentes de diabetes mellitus tipo 1, antecedentes de cetoacidosis, y/o peptido C 1.5 puntos porcentuales durante el periodo de transicion (en la Visita 3 / Semana -2).

Design outcomes

Primary

Measure	Time frame
Outcome name:The central laboratory will carry out all lipid determinations and glycemic, as well as other laboratory tests specified in the study. Once the patient is randomized to active therapy (Visit 4 / Day 1), all lipid and glycemic values will be covered up. Measure:To evaluate the efficacy of MK-0767 in reducing hemoglobin Ale (HbA1c) compared with placebo after 20 weeks of treatment. Timepoints:2 week	—

Measure

Time frame

Outcome name:The central laboratory will carry out all lipid determinations and glycemic, as well as other laboratory tests specified in the study. Once the patient is randomized to active therapy (Visit 4 / Day 1), all lipid and glycemic values will be covered up. Measure:To evaluate the efficacy of MK-0767 in reducing hemoglobin Ale (HbA1c) compared with placebo after 20 weeks of treatment. Timepoints:2 week

—

Secondary

Measure	Time frame
Outcome name:The central laboratory will carry out all lipid determinations and glycemic, as well as other laboratory tests specified in the study. Once the patient is randomized to active therapy (Visit 4 / Day 1), all lipid and glycemic values will be covered up. Measure:To evaluate the efficacy of MK-0767 for reducing fasting plasma glucose (FPG) compared with placebo. Timepoints:2 week	—

Countries

Peru, United States

Contacts

Public ContactStela Lopez

MERCK SHARP & DOHME PERU S.R.L

stela_lopez@merck.com4115935

Outcome results