A Phase IIa, Multicenter, Double-Blind, Randomized, Active-Controlled, Parallel-Arm Clinical Trial to Study the Efficacy and Safety of MK-0941 Compared to Sulfonylurea in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Therapy
- Conditions
- -E14 Unspecified diabetes mellitusUnspecified diabetes mellitusE14
- Registration Number
- PER-172-08
- 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 is> 18 and <70 years old on the day of signing the informed consent.
• The patient has a body mass index (BMI)> 20 kg / m2 and <43kg / m2
• The patient is in one of the following categories: 1. The patient is currently treated with a single oral AHA and has an A1C> 7.5% and <11.0% 2. The patient receives a combination therapy of dual oral AHA at a low dose (i.e. <50% of the maximum labeled dose of each agent) and has an A1C> 7.0% and <10.5%.
• The patient is a man or a woman with no probability of conceiving
• The patient understands the study procedures, the available alternative treatments and the risks involved in the study, and agrees to voluntarily participate in the study by granting their written informed consent.
• The patient has a history of type 1 diabetes mellitus or a history of ketoacidosis, or the patient is being evaluated by the researcher as a patient who probably has type 1 diabetes, confirmed with a C peptide <0.7 ng / mL (0.23 nmol / L).
• The patient has a history of severe hypoglycemia defined as two or more episodes during his life or an episode within the last year that caused hypoglycemic seizures and / or brain disorder (eg, coma, severe confusion, etc.) or the patient has had asymptomatic hypoglycemia (i.e. glucose obtained by digital puncture <50 mg / dL [2.8 mmol / L] without symptoms) within the last 3 months.
• The patient is in a weight reduction program and is not in the maintenance phase, or the patient is taking weight loss drugs (eg orlistat, rimonabant, sibutramine, etc.) within 8 weeks prior to Visit l / Selection.
• The patient has received treatment with an investigational drug within the previous 3 months or is currently participating or plans to participate in another clinical study during the study or one month after completing the study.
• The patient receives treatment, or will probably require treatment, with warfarin or anticoagulants similar to warfarin, digoxin or any other drug with a narrow therapeutic index during the study (see Annex 6.1).
• The patient requires, or will probably require, treatment with> 14 consecutive days or repeated cycles of pharmacological doses of systemic corticosteroids (oral, injectable / parenteral) or ocular during the study.
• The patient has undergone a surgical procedure within 30 days prior to the signing of the informed consent or has planned major surgery during the study.
• The patient has new or progressive signs or symptoms of coronary heart disease or congestive heart failure within the last 3 months
• The patient has a Class II - IV heart condition according to the NYHA (New York Cardiology Association) (see Annex 6.2) or has severe peripheral vascular disease (eg, manifested by claudication with minimal activity, an ischemic ulcer slow closing, or illness that probably requires intervention such as bypass or angioplasty).
• The patient has poorly controlled hypertension, defined as a systolic blood pressure> 160 mmHg or a diastolic blood pressure> 90 mmHg and it is not considered likely that the blood pressure is below these limits for Visit 4 / Day -1 with an adjustment of antihypertensive regimen.
• The patient has a history of active liver disease (other than non-alcoholic liver steatosis), which includes chronic active hepatitis B or C (evaluated by medical history), cirrhosis or symptomatic disease of the gallbladder.
• The patient is HIV positive (based on medical history evaluation).
• The patient has a clinically significant hematologic disorder (eg, aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia).
• The patient is currently treated with antithyroid drugs or radioactive iodine for hyperthyroidism.
• The patient has a history of malignant disease <5 years before signing the informed consent, or> 5 years without documentation of remission / cure.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Weighted Mean Glucose (WMG) is a measure of the amount of glucose in the blood over a period of 24 hours. The WMG was derived from multiple glucose values collected during both fasting and post-meal periods. The weighted mean was used to avoid over-representation of post-meal glucose values.<br><br>Measure:Change From Baseline to Week 6 in 24-hour Weighted Mean Glucose<br>Timepoints:Baseline and Week 6<br>
- Secondary Outcome Measures
Name Time Method