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MULTICENTRIC, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF MK-0767 ADDED TO SULFONILUREA THERAPY IN PATIENTS WITH DIABETES MELLITUS TYPE 2 IMPROPERLY CONTROLLED

MULTICENTRIC, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF MK-0767 ADDED TO SULFONILUREA THERAPY IN PATIENTS WITH DIABETES MELLITUS TYPE 2 IMPROPERLY CONTROLLED

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-018-03
Enrollment
30
Registered
2003-03-12
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

MK-0767 5 mg/dia Type of group
5 mg / day MK-0767 will be administered in single compressed tablets administered orally once a day in the morning for up to 20 weeks. Group name:placebo Type of group
MK-0767 placebo will be administered in single compressed tablets administered orally once a day in the morning for up to 20 weeks.

Sponsors

MERCK SHARP & DOHME PERU S.R.L.,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with type 2 diabetes with inadequate glycemic control in monotherapy with sulfonylurea that meet the following criteria will be incorporated for enrollment in the study. The criteria listed below will be evaluated in Visit 1 / Week -7, unless otherwise indicated. All laboratory measurements will be carried out after an overnight fast> 12 hours.

Exclusion criteria

Exclusion criteria: It excludes participation in the study of those individuals who comply with any of the following criteria in Visit 1 / Week -7 (unless otherwise indicated). All laboratory measurements should be carried out after an overnight fast> 12 hours.

Design outcomes

Primary

MeasureTime frame
Outcome name:HbA1c Measure:Efficacy of MK-0767 to reduce HbA1c compared to placebo after 20 weeks of treatment. Timepoints:8 week—

Secondary

MeasureTime frame
Outcome name:Fasting plasma glucose Measure:Efficacy of MK-0767 to reduce fasting plasma glucose (FPG) compared with placebo after 20 weeks of treatment. Timepoints:4 week—

Countries

Peru

Contacts

Public ContactStela Lopez

MERCK SHARP & DOHME PERU S.R.L

stela_lopez@merck.com4115935

Outcome results

None listed

Source: REPEC (via WHO ICTRP)