DOUBLE BLIND, RANDOMIZED, MULTICENTER, PLACEBO CONTROLLED PARALLEL AND ACTIVE CONTROLLER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF MK-0767 IN THE ALTERATION OF GLUCOSE AND LIPIDS IN PATIENTS WHO HAVE TYPE 2 DIABETES

Not Applicable

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

• Registration Number: PER-075-01
• Lead Sponsor: MERCK SHARP & DOHME PERU S.R.L.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2001-11-30
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

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

Inclusion Criteria

• Men and women not pregnant. All women must have a negative urine pregnancy test at Visit 1. Women of childbearing age must accept the use of appropriate double-barrier contraceptive methods throughout the study and continue for at least 14 days after the last visit of the study. Women of childbearing age are those who are premenopausal or who have not undergone surgical sterilization due to hysterectomy or tubal ligation. The postmenopausal state is defined as the absence of menstruation during the previous year and a half and elevated FSH levels in Visit 1 in the postmenopausal range (as defined by the designated Central Laboratories).
• Between 21 to 75 years of age, inclusive.
• Type 2 Diabetes with the following profile after fasting at night> 12 hours: Virgins patients on antihyperglycemic drugs: At Visit 1: GPA> 126 mg / dL and <250 mg / dL; HbA1c <10.5%; peptide C> 0.8 ng / mL. At Visit 2: GPA> 126 mg / dL and <240 mg / dL. Patients with a single oral hypoglycemic medication: At Visit 1: GPA <200 m ^ dL and HbA1c <10.5%. At Visit 2: GPA> 126 mg / dL and <240 mg / dL and C peptide> 0.8 mg / mL.
• Virgins to antihyperglycaemic drugs or those that are under dietary treatment or with monotherapy of sulfonylureas, meglitinides or other approved insulin secretagogue, metformin or aglucosidase inhibitors only and that wish to discontinue their therapy from Visit 1 and the time it lasts the study.
• Both liver transaminase values ​​in Visits 1 and 2 (ALT and AST) less than or equal to 50% above the ULN (ALT or SGPT <38 mg / dL and AST or SGOT <33 mg / dL) and CPK less than 50% of the ULN (<180 mg / dL). Patients will be allowed to go to Visit 2 for a second ALT and / or AST and / or CPK evaluation in case the values ​​in Visit 1 for ALT and / or AST are less than or equal to 100% above the LSN (ALT <50 mg / dL and AST <44 mg / dL, CPK <40 mg / dL) at the investigator´s discretion.
• Understand the study procedures and agree to participate in the study by providing a written informed consent (evaluated in Visit 1).
• Patients do not consume more than 2 measures of alcoholic beverages per day and agree to comply with the alcohol restrictions specified in Section LE.3.S.3).
• A compliance of the placebo treatment during the transition phase greater than or equal to 75% (as measured by the tablet count).

Exclusion Criteria

• History of Type 1 diabetes and / or a history of ketoacidosis.
• Retinopathy or nephropathy or severe diabetic neuropathy.
• Antihyperglycemic therapy including insulin, either rosiglitazone and pioglitazone or 2 or more oral agents in combination within 8 weeks prior to Visit 1. Note that monotherapy with sulfonylureas, meglitinides or other approved insulin secretagogue, melformin or inhibitors is permitted of α-glucosidase until Visit 1.
• Patients with a history of allergy, intolerance or hypersensitivity to troglitazone, rosiglitazone or pioglitazone, which includes a history of elevated liver function tests, jaundice or hepatotoxicity associated with these treatments.
• LDL-C> 175 mg / dL (or 4.53 mmol / L) at Visit 1 or LDL-C> 160 mg / dL (or 4.14 mmol / L) at Visit 2.
• Total triglycerides> 800 mg / dL (or 9.03 mmol / L) at Visit 1 and> 600 mg / dL (6.77 mmol / L) at Visit 2.
• Lipid reducing agents including bile acid sequestrants, HMG-CoA reductase inhibitors and nicotinic acid derivatives and fibric acid derivatives taken within 4 weeks, or probucol within the previous year, prior to Visit 2 (at Appendix 2 will provide information on other agents that alter lipids, including agents without a prescription).
• Partial ileal shunt within 6 months prior to Visit 2.
• Estrogen replacement therapy or SERM within 8 weeks prior to Visit 1 (patients who are in a stable regime for 8 weeks or more can participate as long as they plan to stay in the same regimen for the duration of the visit. study).
• Patients with a TSH> 5 pIU / dL will be excluded. Patients with a history of hypothyroidism who are on a stable dose of thyroxine and who have a normal TSH level in Visit 1 may be included.
• Patients intolerant to HMG-CoA reductase inhibitors (eg: atorvastatin, cerivastatin, fluvastatin, lovastatin, pravastatin, and simvastatin), nicotinic acid, and fibric acid derivatives (eg, bezafibrate, ciprofibre, closfibrate, fenofibrate, and gemfibrozil) including history of evidence of elevated liver function, jaundice, hepatotoxicity or myopathy (muscle symptoms defined with CPK> 10 times the ULN) associated with these treatments.
• Patients who require continuous treatment with oral corticosteroids (more than 2 weeks) or who are taking oral contraceptives unless they are using them as a double-barrier method for the duration of the study; digoxin, warfarin or anticoagulants similar to warfarin, theophylline, antidysical medications or antiviral medications
• Surgical intervention within 30 days prior to Visit 1.
• Treatment with any other drug under investigation within 30 days prior to Visit 1.
• Renal impairment as measured by serum creatinine> 1.5 mg / dL (or 132.6 mmol / L) or positive hematuria as defined as greater than 5 red blood cells per high power field through the microscopic test. urine.
• Antecedents of nephrotic syndrome, or if proteinuria is detected (+++ and above) in Visit 1, then, a urine collection is performed for 24 hours. If the 24-hour urinary protein is> 3.5 g / 1.73 m2 / 24 hours, then the patient is excluded.
• Viral hepatitis (hepatitis B or C) as determined by detecting the positive antibody against core antigen for hepatitis B and antibodies positive for hepatitis C.
• History of cholelithiasis or other gallbladder disease (within 6 months prior to Visit 1) or other active liver disease, which includes primary biliary cirrhosis or pancre

Study & Design

• Study Type: Interventional
• Study Design: Not specified