Vildagliptin Compared to Glimepiride in Combination With Metformin in Patients With Type 2 Diabetes

Not Applicable

• Conditions: -E11 Non-insulin-dependent diabetes mellitus; Non-insulin-dependent diabetes mellitus; E11

• Registration Number: PER-026-05
• Lead Sponsor: OVARTIS BIOSCIENSES PERU S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-05-30
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

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 6) Agreement to maintain your previous diet and exercise habits

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified