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A MULTICIENTRIC, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF MK-0767 TO PATIENTS WITH TYPE 2 DIABETES THAT PRESENT INACCURATE GLYCEMIC CONTROL IN THE COMBINED THERAPY OF METFORMIN AND SULFONILUREA.

A MULTICIENTRIC, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF MK-0767 TO PATIENTS WITH TYPE 2 DIABETES THAT PRESENT INACCURATE GLYCEMIC CONTROL IN THE COMBINED THERAPY OF METFORMIN AND SULFONILUREA.

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
REPEC
Registry ID
PER-014-03
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

5 mg MK-0767 Type of group
One compressed tablet will be given orally once a day in the morning for up to 20 weeks. Patients will continue to take their stable dose of sulphonylurea and metformin as prescribed by their doctor, unless hypoglycemia develops. Group name:placebo Type of group
A placebo tablet will be given orally once a day in the morning for up to 20 weeks. Patients will continue to take their stable dose of sulphonylurea and metformin as prescribed by their doctor, unless hypoglycemia develops.

Sponsors

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

Eligibility

Inclusion criteria

Inclusion criteria: Age> 21 and <78 years. In stable doses of metformin and sulfonylurea for at least 2 weeks before Visit 2 / Week -6. Understanding of study procedures and agreement of participate in the study through informed consent written.

Exclusion criteria

Exclusion criteria: Patients with a history of type 1 diabetes mellitus and / or history of ketoacidosis and / or C-peptide <0.8 ng / mL (<0.26 nmol / L). Patients with the following treatments for diabetes during the 8 weeks prior to Visit 1. Patients with a history of allergy, intolerance or hypersensitivity to troglitazone, rosiglitazone, pioglitazone or other PPAR-agonists and including a history of elevated liver function test, jaundice, or hepatotoxicity associated with these treatments.

Design outcomes

Primary

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

Secondary

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

Countries

Peru, United States

Contacts

Public ContactStela Lopez

MERCK SHARP & DOHME PERU S.R.L

stela_lopez@merck.com4115935

Outcome results

None listed

Source: REPEC (via WHO ICTRP)