None listed
Conditions
Interventions
GROUP 1 Type of group
Patients in this group will be treated with Placebo, in tablets, PO, BID, for 12 weeks.
Group name:GROUP 7 Type of group
Patients in this group will be treated with Pioglitazone, in tablets, at a dose of 30 mg, PO, BID, for 12 weeks
Sponsors
GLAXOSMITHKLINE PERU S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects with the documented diagnosis of T2DM and who have a HbA1c level ≥ 7.5% and ≤ 9.5%. 2. Subjects that are treatment naives. 3. Subjects who are between 18 and 70 years old. 4. Women are eligible to enter and participate in this study, if they: Do not have the potential to conceive. 5. Informed Consent: A written, signed and dated consent must be obtained from the subject before any procedure is performed.
Exclusion criteria
Exclusion criteria: 1. Diagnosis of Type I Diabetes Mellitus 2. History of ketoacidosis that has required hospitalization. 3. Thyroid disorder. 4. Body Mass Index (BMI) 40 Kg./m2. 5. Gain or significant weight loss in the 3 months prior to Screening. 6. Have taken insulin for more than 2 weeks in 12 months prior to screening or at any time in the 3 months prior to screening. 7. Have taken any anti-diabetic medication for more than 4 weeks in the 12 months prior to screening or at any time in the 3 months prior to screening. 8. Recent history or presence of a significant acute cardiovascular disease. 9. Fasting plasma triglycerides> 400 mg / dL during Screening. 10. Has a diagnosis of active hepatitis, or clinically significant elevation of liver enzymes. 11. Secondary causes of diabetes. 12. Significant kidney disease. 13. Recurrent infections of the genitourinary tract. 14. A positive qualitative urinary reactive tape test for leukocytes, erythrocytes or nitrites in the Screening. 15. Are currently taking or have taken any of the prohibited medications in the 3 months prior to Screening. 16. Patient is currently pregnant or breastfeeding. 17. Current smokers who are not able to refrain from smoking. 18. Has a history of alcohol or substance abuse in the past year or abuse of alcohol or substances during treatment. 19. You have participated in a study with a marketable drug or research in the last 3 months. 20. If in the opinion of the investigator the patient has risks of not complying with the study procedures, or can not read, understand, or complete the materials related to the study. 21. Allergies known to any excipient or history of drugs or other allergies, which contraindicate their participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Levels in peripheral blood of glycosylated hemoglobin (HBA1c). A fast of at least 8 hours will be required. Measure:Changes in HbA1c. Timepoints:Week 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Criterion 1: Levels in peripheral blood of glycosylated hemoglobin (HBA1c). A fast of at least 8 hours will be required. Criterion 2: Peripheral blood glucose levels, after an 8-hour fast. Criterion 3: Fructosamine peripheral blood levels. Measure:Secondary efficacy: 1) Change from baseline HbA1c in weeks 4 and 8. 2) Change from baseline to FPG. 3) Change from the basal Fructosamine. Timepoints:HbA1c: Weeks 4 and 8. FPB and Fructosamine: Weeks 4, 8 and 12. ; Outcome name:Criterion 1: Clinical evaluation of any unpleasant medical occurrence that occurs in a patient associated with the use of the research product Criterion 2: Daily Glucose Monitoring Record, where the symptoms of hypoglycemia and glucose levels during the episode will be recorded. Criterion 3: Urinalysis. Criterion 4: Heart rate in duplicate, after having rested for 5 minutes and measuring the pulse by palpation of brachial or radial pulse for 30 seconds and blood pressure, after having rested for 5 minutes, with a calibrated sphygmomanometer in one position pitch and then three minutes of standing. Criterion 5: standard 12-lead ECG, where the heart rate and PR, QRS, QT and QTc intervals will be measured. Criterion 6: Panels of serum chemistry and hematology. Measure:Security: 1) Adverse events. 2) Hypoglycemia. 3) Urogenital infections. 4) Vital signs. 5) Electrocardiogram. 6) Laboratory evaluations. Timepoints:Criteria 1, 2, 4 and 6: Weeks 0, 2, 4, 6, 8, 12 and during follow-up. Criterion 3: Weeks 0, 12 and during follow-up. Criterion 5: Weeks 0, 4, 12 and during follow-up. ; Outcome name:1) Questionnaire on Hunger, Cravings and Fullness (HCF). 2) Short form of overactive bladder (OAB-q SF). 3) Visual Analog Sed Scale (VAS). 4) Questionnaire on satisfaction with the oral antidiabetic agent (SOADAS). Measure:Health results. Timepoints:Weeks 0, 2, 4, 6, 8, 12 and during follow-up. | — |
Countries
Argentina, Bulgaria, Chile, Costa Rica, Czech Republic, Germany, Hungary, India, Latovia, Lithuania, Mexico, New Zealand, Peru, Poland, Romania, Russian Federation, South Africa
Outcome results
None listed