A Study to Assess the Safety and Efficacy of MK8245 in Patients With Type 2 Diabetes Mellitus and Inadequate Glycemic Control (MK8245-005 AM2)
- Conditions
- -E10 Insulin-dependent diabetes mellitus-E14 Unspecified diabetes mellitusInsulin-dependent diabetes mellitusUnspecified diabetes mellitusE10E14
- Registration Number
- PER-159-08
- Lead Sponsor
- MERCK SHARP & DOHME PERU S.R.L.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• The patient has type 2 diabetes mellitus (T2DM).
• The patient´s age is> 18 and <65 years on the day of the signing of the informed consent.
• The patient has a body mass index (BMI)> 27 kg / m2 and <43 kg / m2.
• The patient never received a drug before or currently does not receive AHA (without AHA for> 12 weeks), and on Visit 1 / Selection Visit has AIC> 7% and <10%
• The patient is a male or female person without reproductive potential.
• The patient understands the study procedures, the available alternative treatments and the risks involved in the study, and agrees to participate voluntarily by giving written informed consent.
• The patient has an FPG> 130 mg / dL (7.2 mmol / L) and <260 ing / dL (14.4 mmol / L).
• The patient has a compliance> 85% with respect to the study drug during the transition with placebo in simple blind (as determined by capsule count).
• The patient complies with the diet and exercises during the transition period.
• The patient has successfully completed the 24-hour home procedures, which include consuming> 50% of each meal based on caloric content.
• The patient has a history of type 1 diabetes mellitus or a history of ketoacidosis, or the patient is being evaluated by the investigator as a possible patient with type 1 diabetes confirmed with a C-peptide value <0.7 ng / mL (<0.23 nmol / L) .
• The patient has been treated with a PPARy agent (ie, TZD [pioglitazone or rosiglitazone]) or with insulin therapy in the last 12 weeks.
• The patient has been treated with lipid-lowering drugs, such as statins (ie, HMG-CoA reductases [eg, simvastatin, atorvastatin]), fibrates (for example, gemfibrozil, fenofibrate), czetimibe, niacin, or sequestrants of bile acids within the previous 4 weeks.
• The patient has been in a weight reduction program and is not in the maintenance phase, or the patient started with weight loss drugs (for example, orlistat, rimonabant, sibutramine, etc.) within the last 12 weeks
• The patient is being treated with immunosuppressive or immunomodulatory agents (for example, methotrexate, cyclosporine, etanercept), or the patient is receiving treatment with pharmacological doses of corticosteroidcs - or will probably need such treatment or receive physiological replacement therapy with oral corticostcroids (it is say, a patient with adrenal insufficiency).
• The patient is currently participating in a study, or has participated in a study with or without a compound or device under investigation within 12 weeks prior to signing the informed consent.
• The patient has undergone a surgical procedure within a period of 30 days prior to the signing of the informed consent, or plans to undergo major surgery.
• The patient has a medical history of active liver disease (other than non-alcoholic liver steatosis), including chronic active hepatitis B or C (evaluated by medical history), cirrhosis or symptomatic gallbladder disease.
• The patient has a history of coronary heart disease or congestive heart failure.
• The patient suffered a stroke or a transient ischemic neurological disorder during the last 6 months.
• The patient suffers from severe peripheral vascular disease (for example, manifested by claudication with minimal activity, ischemic ulcer with difficulty healing, or a disease that will probably need intervention, such as a coronary bypass or an angioplasty).
• The patient has a systolic blood pressure> 160 mm Hg or diastolic blood pressure> 90 mm Hg and the blood pressure is not considered likely to decrease below these limits at Visit 3 / Week 2 with an adjustment in the antihypertensive drug.
• The patient is HIV positive (as assessed by the medical history).
• The patient is currently being treated for hyperthyroidism.
• The patient suffers from a clinically important hematologic disorder (for example, aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia).
• The patient has a history of malignant disease <5 years before the signing of the informed consent, except for basal or squamous cell skin cancer or cervical cancer in situ that were satisfactorily treated. A patient with a history of malignant disease> 5 years before signing informed consent should not present evidence of disease.
• The patient has a history of macular edema or vitreous hemorrhage.
• The patient has a recent history (ie, in the last 2 weeks) of eye infection or other inflammatory eye or conjunctive condition, including uveitis or scleritis.
• The patient has a history of wearing conta
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:The 24-hour WMG is derived from multiple glucose values collected during both fasting and post-meal periods. A weighted rather than a simple mean is used to avoid overrepresentation of post-meal glucose values.<br>Blood samples for glucose were to be collected immediately prior to (sample -10 minutes), and 0, 15, 30, 60, 90, 120, and 180 minutes after each meal, and overnight (at midnight, 3 AM, and 5 AM) and fasting at 7 AM. Patients were to be domiciled for approximately 26 hours at the site where standard meals were provided and physical activity monitored.<br><br><br>Measure:Change From Baseline in 24-hour Weighted Mean Glucose (WMG) at Week 4<br>Timepoints:Baseline and Week 4<br>
- Secondary Outcome Measures
Name Time Method