None listed
Conditions
Interventions
Group 1 Type of group
In addition to the standard treatment with metformin, patients will take a daily pill of:
- Bottle A: LAF237 50 mg or LAF237 placebo 2 times a day for 5 years.
The dose will be titrated according to the patient s need.
Group name:Group 2 Type of group
In addition to the standard treatment with metformin, patients will take a daily pill of:
- Bottle A: Glimepiride 2 mg or Glimepiride placebo which may be increased up to 6 mg according to the patient s need.
Sponsors
NOVARTIS BIOSCIENSES PERU S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: 1) Men and women (not fertile, or who are using a medically approved method of contraception). 2) Patients with Type 2 Diabetes who have received metformin for at least 3 months, at a stable dose of at least 1500 mg daily for a minimum of 4 weeks before Visit 1. 3) Age between 18 and 73 years. 4) BMI between 22-45 kg / m2. 5) HbA1c> 6.5% and <or equal to 8.5%. 6) Agreement to maintain your previous diet and exercise habits
Exclusion criteria
Exclusion criteria: 1) Pregnant or lactating women. 2) Diagnosis or history of: a) Type 1 diabetes, diabetes resulting from pancreatic damage, or secondary forms of diabetes. b) Acute metabolic complications of diabetes. 3) Evidence of significant diabetic complications. 4) Acute infections that can affect the control of blood glucose within 4 weeks prior to Visit 1. 5) Antecedents of: a) Torsades de pointes, sustained and clinically relevant ventricular tachycardia or ventricular fibrillation. b) Coronary angioplasty within the last 3 months. c) Any of the following conditions, within the last 6 months: myocardial infarction (MI), coronary artery bypass surgery, unstable angina, or cerebrovascular accident. 6) Congestive heart failure (CHF) that requires pharmacological treatment. 7) Any of the following abnormalities in the ECG: a) Second-degree atrioventricular (AV) block. b) Third-degree AV block. c) Long QTc (> 500 ms) 8) Malignancy within the last 5 years. 9) Liver disease. 10) Renal disease or significant renal dysfunction. 11) Treatment with growth hormone or similar drugs. 12) Concurrent medical condition that could interfere with the interpretation of efficacy and safety data during the study. 13) Donation of one unit (500ml) or more of blood, or significant blood loss equivalent to at least one unit within the last 2 weeks, or blood transfusion within the previous 8 weeks. 14) Contraindications and warnings, in accordance with the specific glimepiride leaflet of each country. 15) Known sensitivity to glimepiride or other drugs containing sulfur. 16) Treatment with any oral antidiabetic drug, except metformin, within 3 months prior to Visit 1. 17) Chronic insulin treatment within the previous 6 months. 18) Chronic treatment with oral or parenteral corticosteroids within 8 weeks prior to Visit 1. 19) Treatment with antiarrhythmic classes la. Ib and Ic or III. 20) Thyroid hormone replacement therapy is allowed if the dose has been stable for at least 3 months and the thyroid stimulating hormone (TSH) is within normal limits at Visit 1. 21) Treatment with experimental drugs within 4 weeks prior to Visit 1. 22. Treatment with any drug that has a known and frequent toxicity in a larger organic system within the last 3 months. 23. Any of the following laboratory abnormalities: a) ALT, AST greater than 3 times the upper limit. b) Direct bilirubin greater than 1.3 times the upper limit. c) Serum creatinine levels> 132 umol / L (1.5 mg / dL) in men,> 123umol / L (1.4 mg / dL) in women. d) clinically significant TSH outside the normal range. e) Clinically significant laboratory abnormalities. f) Fasting triglycerides> 7.9 mmol / L (> 700 mg / dL). g) Glutamic acid (GAD) -carboxylase antibodies (GAD) positive. 24. History of substance abuse (including alcohol) within the past 2 years. 25. Patients that may be unreliable, and patients that the researcher considers unfit for study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Time to failure in HbA1c (defined as HbA1c> 8.0%) Measure:Long-term efficacy of the addition treatment with LAF237 Timepoints:Repeated measurement within 4 weeks (28 days) after the initial measurement. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:1) Fasting plasma glucose 2) Body weight 3) Beta cell function 4) Insulin resistance 5) Fasting lipids Measure:Secondary efficiency of LAF237 Timepoints:1) Fasting plasma glucose: Weeks 1, 2, 4, 5, 6, 7, 8, 9, 19 and every 3 months from this point. 2) Body weight: Weeks 1, 2, 4, 5, 6, 7, 8, 9, 19 and every 3 months from this point. 3) Beta cell function: Weeks 2,7, and 10. 4) Insulin resistance: Weeks 2.7, and 10. 5) Fasting lipids: Weeks 2, 7, and 10. ; Outcome name:1) Report of adverse effects 2) Clinical and laboratory evaluation Measure:Safety of LAF237 Timepoints:At the time the event is presented | — |
Countries
Germany, Peru, United States
Outcome results
None listed