A Once-Daily Dose-Ranging Study of GSK189075 Versus Placebo In The Treatment of Type 2 Diabetes Mellitus in Treatment-Naïve Subjects
- Registration Number
- PER-085-07
- Lead Sponsor
- GLAXOSMITHKLINE PERU S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Not specified
- Target Recruitment
- 0
• Subjects with a documented diagnosis of DMT2 and HbA1c 7.5% and 9.5% measured by the central laboratory in Visit 1 and Visit 2.
• Subjects without previous exposure to treatment and who have taken 2 weeks of insulin or 4 weeks of any oral antidiabetic agent in the last 12 months, but none during the 3 months prior to the screening or newly diagnosed subjects and who have been treated with diet and exercise a minimum of 8 weeks.
• Subjects between 18 and 70 years of age inclusive at the time of the selective examination.
• Eligible female subjects should not have reproductive potential (for example, surgically sterilized women regardless of age (for example, total hysterectomy or documented bilateral oophorectomy) or post-menopausal women (for example, they have not had a menstrual period at a minimum of 12 consecutive months.) All female subjects must have a negative urine pregnancy test on the day of the random distribution and before.
• Informed Consent: before performing any of the study procedures, you will
• you must obtain a written informed consent; signed and dated by the subject.
• Metabolic Disease: Diagnosis of type 1 diabetes mellitus, history of ketoacidosis that required hospitalization, thyroid disorder, TSH <0.4MUI / L or> 5.5mlU / L (> 5.5 MCUI / mL) on the selective examination, IMG of <25 kg / m ^ or> 40 kg / m2, Major weight gain or loss (defined as> 5% of total body weight) in the three (3) months prior to the selective examination.
• Medication for diabetes: The subject has taken insulin for> 2 weeks in the 12 months prior to the selective examination or at some time in the 3 months prior to the selective examination. The subject has taken an oral antidiabetic medication for more than 4 months. weeks in the 12 months prior to the selective examination or at some time in the 3 months prior to the selective examination.
• Cardiovascular Disease: Recent history or presence of clinically significant cardiovascular disease, including: documented myocardial infarction in the 6 months before the selective examination. Coronary revascularization including percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG), whether it has been planned and / or occurred in the 6 months prior to the selective examination. Unstable angina in the 6 months prior to the selective examination. Clinically significant supraventricular arrhythmias requiring medical therapy or a history of sustained or nonsustained ventricular tachycardia. Heart valve disease, symptomatic, or requiring therapy in addition to the prophylaxis of endocarditis. Cardiac congestive insufficiency (CCI Class II to IV, according to the New York Heart Association (NYHA)) that requires pharmacological treatment. Class I according to NYHA can be included according to the information for the local prescription for pioglitazone. Blood pressure (BP)> 150 / 100mmHg. If a subject receives allowed antihypertensive therapy, then he must take a stable dose of therapy for at least 3 months prior to the screening. Based on the local readings the subject has a QTc interval (from Bazett) 450msec in the selective examination and then two additional ECGs taken with, Other abnormalities in the ECG, clinically significant that, in the opinion of the researcher, may affect the interpretation of Efficacy and safety data or that otherwise contraindicate participation in a clinical study with a new chemical entity. Plasma triglycerides 400mg / dL (4.56mmol / L) at selective examination. If a subject receives lipid-lowering therapy allowed, then he must take a stable dose of therapy for at least 3 months before the screening. Sequestrants of Niacin and bile acid are prohibited.
• Hepatic Disease: The subject has a diagnosis of active hepatitis (surface antigen for hepatitis B or hepatitis C antibodies), or clinically significant elevation of the liver enzyme, including: Any of the following enzymes greater than 2 times the upper limit of the reference range value (LSRR) on selective screening, alanine transaminase (ALT), transaminase aspartate (AST), alkaline phosphatase (AP), subject has a total bilimibin level that is> 1.5 times the LSRR on selective screening , with the exception of suspected or confirmed Gilbert´s disease.
• Pancreatic Disease: Secondary Causes of Diabetes: History of Acute or Chronic Pancreatitis
• Kidney Disease: Significant renal disease in the selective examination,
• Concurrent Illness: The patient has any concurrent condition or clinically significant abnormality identified on the physica
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:At the visits specified in Table 3, blood samples will be obtained for HbA1c.<br>Measure:Variation in HbA1c<br>Timepoints:During the study<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:HbA1c, GPA at all times and fructuosamine collected at the visits specified in Table 3.<br>Measure:Variation in HbA1c, GPA at all times and fructuosamine<br>Timepoints:During the study<br>;<br>Outcome name:Fasting samples for total cholesterol (CT), low-density lipoprotein (LDL-C), high-density lipoprotein (HDL-C) and TG will be taken at the visits specified in Table 3.<br>Measure:Variation in lipid evaluation<br>Timepoints:During the study<br>;<br>Outcome name:A 24-hour urine sample of all subjects will be required at Visit 3 (Week 0) and Visit 8 (Week 12) or the Early Leaving Visit to measure urine glucose and creatinine in urine.<br>Measure:Excretion of glucose in the urine<br>Timepoints:Visit 3 and visit 8<br>