Estudio Factorial de la Coadministracion de MK-0431 y Metformina en Pacientes con Diabetes Mellitus Tipo 2

A FACTORIAL, MULTICENTER, RANDOMIZED, DOUBLE-BLIND STUDY OF THE CO-ADMINISTRATION OF MK-0431 AND METFORMIN IN PATIENTS WITH DIABETES MELLITUS TYPE 2 WHO HAVE AN INAPPROPRIATE GLYCEMIC CONTROL

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

REPEC

Registry ID

PER-018-05

Enrollment

Registered

2005-05-27

Start date

2005-06-21

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

Group 1 Type of group

1) Pharmacological Rest Period: 12 weeks. Suspension of any antihyperglycemic agent that the patient is taking 2) Transition Period: 2 weeks. All will start treatment with a placebo during this period. 3) Double Blind treatment period: a) Phase A: Period of 24 weeks. 50 mg of MK-0431 2 times a day and 500 mg of Metformin 2 times a day will be administered. b) Phase B: Period of 30 weeks. 50 mg of MK-0431 2 times a day and 500 mg of Metformin 2 times a day will be administered.

1) Pharmacological Rest Period: 12 weeks. Suspension of any antihyperglycemic agent that the patient is taking 2) Transition Period: 2 weeks. All will start treatment with a placebo during this period. 3) Double Blind treatment period: a) Phase A: Period of 24 weeks. The placebo will be administered. b) Phase B: Period of 30 weeks. 500 mg of metformin will be given 4 times a day

Eligibility

Inclusion criteria

Inclusion criteria: a) The patient suffers from diabetes mellitus type 2 (T2DM). b) The patient is between> 18 and 7.5% and 11% in Visit 1 / Screening Visit. 3) The patient is currently receiving monotherapy with an antihyperglycemic agent or dual combination oral therapy and has a HbAic level> 7% and 6.5% and <7% at Visit 1 / Screening Visit, and has been approved by the Merck clinical monitor.

Exclusion criteria

Exclusion criteria: a) The patient has developed a medical condition or disorder that, in the opinion of the researcher or Merck´s clinical monitor, could put the patient at risk. b) The patient is receiving or is likely to require an excluded or prohibited medication.

Design outcomes

Primary

Measure	Time frame
Outcome name:HbA1C Fasting blood glucose Glucose tolerance at 60 and 120 minutes Peptide C Insulin Measure:Efficacy of MK-0431 Timepoints:HbA1C: Weeks 1, 2, 3, 12, 13, 14, 19, 24, 29, 34, 39, 45, 51, 54. Fasting glucose: Weeks 1, 2, 3, 12, 13, 14, 19, 24, 29, 34, 39, 45, 51, 54. Tolerance to glucose at 60 and 120 minutes: Weeks 1, 2, 3, 12, 13, 14, 19, 24, 29, 34, 39, 45, 51, 54. Peptide C: For patients who wish. Weeks 1, 2, 3, 12, 13, 14, 19, 24, 29, 34, 39, 45, 51, 54. Insulin: For the patients who wish. Weeks 1, 2, 3, 12, 13, 14, 19, 24, 29, 34, 39, 45, 51, 54.	—

Measure

Time frame

Outcome name:HbA1C Fasting blood glucose Glucose tolerance at 60 and 120 minutes Peptide C Insulin Measure:Efficacy of MK-0431 Timepoints:HbA1C: Weeks 1, 2, 3, 12, 13, 14, 19, 24, 29, 34, 39, 45, 51, 54. Fasting glucose: Weeks 1, 2, 3, 12, 13, 14, 19, 24, 29, 34, 39, 45, 51, 54. Tolerance to glucose at 60 and 120 minutes: Weeks 1, 2, 3, 12, 13, 14, 19, 24, 29, 34, 39, 45, 51, 54. Peptide C: For patients who wish. Weeks 1, 2, 3, 12, 13, 14, 19, 24, 29, 34, 39, 45, 51, 54. Insulin: For the patients who wish. Weeks 1, 2, 3, 12, 13, 14, 19, 24, 29, 34, 39, 45, 51, 54.

—

Secondary

Measure	Time frame
Outcome name:Clinical evaluation Intensity scale od adverse effects Measure:Efficacy of MK-0431 Timepoints:Weeks 1, 2, 3, 12, 13, 14, 19, 24, 29, 34, 39, 45, 51, 54. (During the clinical visits)	—

Countries

Australia, Colombia, Costa Rica, Guatemala, Hungary, Lithuania, Malasya, New Zealand, Norway, Philippines, Puerto Rico, Russian Federation, South Africa, United Kindgdom, United States

Contacts

Public ContactStela Lopez

MERCK SHARP & DOHME PERU S.R.L

stela_lopez@merck.com4115935

Outcome results