None listed
Conditions
Interventions
GROUP 1 Type of group
This group will be treated with LAF-237, in 50 mg tablets, at a dose of 50 mg, PO, QD, for 52 weeks + Metformin, in tablets, at a dose equal to or greater than 1500 mg, PO, QD, per 52 weeks
Group name:GROUP 2 Type of group
This group will be treated with Gliclazide, in capsules of 80 mg, at a dose of 320 mg, PO, QD, for 52 weeks + Metformin, in tablets, at a dose equal to or higher than 1500 mg, PO, QD, for 52 weeks .
Sponsors
NOVARTIS BIOSCIENSES PERU S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female patients (not fertile or using a medically approved method of contraception, 18 to 78 years of age). 2. Type 2 diabetes who have received metformin for at least three months and who have been on a stable dose of at least 1500 mg daily for a minimum of 4 weeks before Visit 1 3. Body mass index (BMI) in the range of 22-45 kg / m2. 4. HbA1c 7.5% -11%. 5. FPG <15 mmol / L (270 mg / dl) and intention to maintain the diet and previous exercise.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women. 2. History of type 1 diabetes, diabetes that results from pancreatic damage, or secondary forms of diabetes. 3. Acute metabolic complications of diabetes in the last six months. 4. Evidence of significant diabetic complications. 4. Acute infections that may affect the control of blood glucose in the 4 weeks prior to the visit 1. 5. History of Torsade de pointes, of ventricular tachycardia or sustained and clinically relevant ventricular fibrillation. 6. Percutaneous coronary intervention in the last three months. 7. Myocardial infarction, coronary artery bypass surgery, unstable angina or stroke in the last 6 months. 8. Congestive heart failure that requires pharmacological treatment. 9. Second-degree AV block (Mobitz 1 and 2), third-degree AV block, prolonged QTc. 10. Malignant tumor including leukemia and lymphoma in the last 5 years. 11. Liver disease. 12. Kidney disease or kidney dysfunction. 13. Acromegaly or treatment with growth hormone or similar medications. 14. Concurrent medical condition that may interfere with the interpretation of efficacy and safety data during the study. 15. Donation of one unit of blood or more, significant blood loss equivalent, at least one unit of blood in the last 2 weeks or a blood transfusion in the last 8 weeks. 16. Contraindications and precautions according to the country-specific label for gliclazide or metformin not listed in the other exclusion criteria. 17. Known sensitivity to gliclazide or other medications containing sulfur. 18. Treatment with any oral antidiabetic agent other than metformin in the last 3 months prior to the visit 1. 19. Chronic treatment with insulin in the last 6 months. 20. Chronic oral or parenteral corticosteroid treatment in the 8 weeks prior to Visit 1. 21. Treatment with antiarrhythmics of class la, Ib and lc or III. 22. Treatment with investigational drugs within 4 weeks prior to Visit 1. 23. Treatment with any medication with frequent and known toxicity in the last 3 months. 24. Any of the following significant laboratory abnormalities: ALT, AST greater than 3 times the upper limit of the normal range, direct bilirubin greater than 1.3 times the upper limit of the normal range, serum creatinine levels ≥ 132 umol / L in men and ≥ 123 umol / L in women, history of creatinine clearance abnormality, TSH outside the normal range at visit 1, clinically significant laboratory abnormalities, confirmed by repeated measurements, fasting triglycerides> 7.9 mmol / l. 25. History of abuse of active substances in the last 2 years and potentially untrustworthy patients and those that the investigator deems inappropriate for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Measurement of serum levels of glycosylated hemoglobin (HBA1c). Measure:Change from baseline HbA1c. Timepoints:Week 52 or the last visit in which there is a measurement of HbA1c. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Serum glucose levels after a fasting period of 8 hours, fasting plasma levels of insulin, proinsulin and lipids (triglycerides, total cholesterol and fractions - LDL, HDL, non-HDL and VLDL). Body weight: Measured with light clothing and without shoes. HOMA B and HOMA IR: Mathematical index that measure the insulin and B cell reserve, based on fasting serum glucose, insulin and proinsulin levels. Measure:Secondary Efficacy: Changes in the following variables: 1) Fasting plasma glucose (FPG). 2) Insulin. 3) Proinsulin. 4) Proinsulin / insulin. 5) Lipids. 6) Body weight. 7) HOMA B and HOMA IR. Timepoints:52 Weeks. ; Outcome name:Determination of those patients who meet any of the following endpoints: 1. Final parameter HbA1c 0.7%. 5. Absolute reduction of HbA1c from the baseline to the end point ≥ 0.5%. Measure:Responders analysis. Timepoints:52 Weeks. ; Outcome name:Criterion 1: Clinical evaluation of the appearance or worsening of any sign, symptom or undesirable medical condition that occurs after the start of the study medication, even if it is considered that this event is not related to the study medication. Criterion 2: Hematology and serum chemistry panels, urine tests. Criterion 3: Patient s diary. From this instrument we will extract data about the symptoms of hypoglycemia, glucose levels <3.1 mmol / L (56 mg / dL), the action taken against these episodes and the classification according to their severity. Measure:Safety: 1) Frequency of emerging adverse events. 2) Number alterations of laboratory values. 3) Frequency and severity of hypoglycemic events. Timepoints:Criteria 1 and 3: Weeks 4, 8, 12, 16, 24, 32, 40 and 52. Criterion 2: Before starting treatment and in weeks 4, 12, 24, 40 and 52. ; Outcome name:Criterion 1: Scale Short Format-36 (SF-36), which consists of 8 profiles: Physical Performance, Physical Role, Body pain, General Health, Vitality, Social functio | — |
Countries
Czech Republic, Denmark, Germany, Hungary, India, Italy, Slovakia, Spain, Switzerland, United Kindgdom
Outcome results
None listed