MULTICENTER, DOUBLE-BLIND, RANDOMIZED STUDY TO EVALUATE THE SAFETY AND EFFECTIVENESS OF THE ADDITION OF MK-0431 IN COMPARISON WITH SULFONILUREA THERAPY IN PATIENTS WITH TYPE 2 DIABETES IN MONOTHERAPY WITH METFORMIN WHO HAVE AN INAPPROPRIATE GLYCEMIC CONTRO

Not Applicable

• Conditions: -E119 Non-insulin-dependent diabetes mellitus, without complications; Non-insulin-dependent diabetes mellitus, without complications; E119

• Registration Number: PER-074-04
• Lead Sponsor: MERCK SHARP & DOHME PERU S.R.L., MERCK & CO.INC.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2004-11-29
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

• The patient suffers from type 2 diabetes mellitus (T2DM).
• The patient is> 18 and <78 years of age.
• The patient understands the study procedures and agrees to participate in it by providing written informed consent
• The patient is not pregnant and is not breastfeeding and does not plan to become pregnant during the course of the study and post-study follow-up period.
• The patient is a man, or a woman who is highly unlikely to conceive
• The patient is currently receiving monotherapy with metformin at a dose> 1500 mg / day, and has an HbA1c> 6.5% and <10% at the Screening Visit or visit 1.
• HbA1c is> 6.5% and <10% at Visit 3, or during the 2 weeks prior to that visit. NOTE: Once a patient has started the placebo transition at Visit 3, if HbA1c at Visit 3 is not within the inclusion criteria for HbA1c at Visit 3, another simple measurement can be performed at the researcher´s criterion. If the repeated value meets the inclusion criteria for HbA1c at Visit 3, the patient can continue in the study.
• The patient has a compliance> 75% (as measured by the tablet count) with respect to the placebo treatment during the transition.

Exclusion Criteria

• The patient has a history of type 1 diabetes mellitus or a history of ketoacidosis.
• The patient required insulin in the last 8 weeks.
• Hypersensitivity or contraindication to a drug sulphonylurea (for example, glipizide) and biguanide (for example, metformin). (Note: Hypoglycaemia is not considered a hypersensitivity to a sulphonylurea medication).
• The patient is following a weight loss program and is not in the maintenance phase.
• The patient started taking a medicine to lose weight (for example, orlistat or sibutramine) in the last 8 weeks.
• The patient is receiving pharmacological doses of corticosteroids or is likely to require treatment with them for> 14 consecutive days or during repeated cycles. Note: Inhaled, nasal and topical corticosteroids are allowed.
• The patient is receiving an immunosuppressive / immunomodulatory agent or is likely to require one (eg, cyclosporine, methotrexate, etanercept).
• The patient has undergone surgery that required general anesthesia in the last 30 days or the patient has planned surgery. Note: Patients who have planned minor surgery can enroll after approval of the Merck medical monitor.
• The patient has received treatment with an investigational drug in the last 8 weeks. ,
• The patient has an ALT or serum AST> 2.0 times the Upper Normal Limit (ULN). Note: Patients whose ALT or serum AST exceeds this limit can be reassessed once if the investigator considers that the value does not reflect the clinical status of the patient.
• Creatinine in serum> 1.4mg / dL (123.8 ^ mol / L) in men and> 1.3 mg / dL (114.9 ^ mol / L) in women or estimated creatinine clearance (using the Cockcroft-Gault formula) <60 mL / min.
• The patient has> 0.5 mg of albumin per mg of creatinine in the urine, as measured by the central laboratory. Note: Only patients whose reactive urine strip at the site reveals more than 1+ of protein should analyze their albumin in urine and creatinine in urine.
• The patient has a level of triglycerides (TG)> 600 mg / dL (6.78 mmol / L) and the researcher considers that it is unlikely that he will respond to the diet / exercises and / or medication to avoid exceeding the level of TG> 600 mg / dL (6.78 mmol / L) at Visit 3 / Seinana -2.
• The patient has a TSH <0.100 | xU / mL or> 15 p.U / mL.
• The patient has a TSH> 6 fiU / mL but <15 jttU / mL and does not wish, or is not considered appropriate, to initiate / adjust a thyroid hormone replacement therapy, in such a way that the patient will avoid exceeding TSH> 6 fiU / mL at Visit 3. Note: If thyroid hormone replacement therapy is initiated or adjusted due to a TSH level> 6 [iü / mL but <15 / xU / mL, the dose of replacement therapy Thyroid hormones should remain stable for 5 weeks before their recurrence at Visit 3.
• The patient suffers from cirrhosis, active liver disease (different from fatty liver), or symptomatic active cholecystopathy.
• The patient suffers from chronic myopathy, or a progressive neuromuscular or neuromuscular disorder (eg, multiple sclerosis or polymyositis).
• The patient has one of the following conditions in the past 6 months: Acute coronary syndrome (eg, MI or unstable angina), Coronary artery surgery (eg,: GABG or PTCA), Stroke, Transient ischemic neurological disorder
• The patient presents new signs or symptoms of coronary heart disease, or worsening thereof, in the last 3 months.
• The patient suffers from a sever

Study & Design

• Study Type: Interventional
• Study Design: Not specified