Efficacy and Long-Term Safety of Vildagliptin as Add-on Therapy to Metformin in Patients With Type 2 Diabetes

Not Applicable

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

• Registration Number: PER-012-09
• 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: 2009-04-29
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

• Man, non-fertile women or women with the potential to become pregnant who use a medically approved method of birth control.
• Age in the range of 18 - 78 years inclusive in Visit 1.
• Patients with DMT2 treated with metformin for at least 3 months and with a stable dose of at least 1,500 mg daily for a minimum of 4 weeks before Visit 1.
• Agreement to maintain the same dose of metformin throughout the study.
• HbA1c> 7.0 and <9.5% in Visit 1.
• Body Mass Index (IMG) in the range of 22 - 45 kg / m2 in Visit 1.

Exclusion Criteria

• Pregnant or nursing women (breastfeeding).
• GPA> 270 mg / dL (> 15.0 mmol / L).
• Any of the following significant laboratory abnormalities: Clinically significant TSH outside the normal range at Visit 1. Clinically significant renal dysfunction indicated by serum creatinine levels> 1.5 mg / dL (132 pmol / L) for men and> 1.4 mg / dL (123 pmol / L) for women at Visit 1 or a history of abnormal creatinine clearance. High fasting triglycerides> 500 mg / dL at Visit 1 confirmed with repeated measurement within 3 working days. Alanine aminotransferase (ALT) and / or aspartate aminotransferase (AST)> 2 X upper limit of normal (ULN) in Visit 1, confirmed by a repeated measure within 3 working days. Total bilirubin> 2 x ULN and / or direct bilirubin> of ULN in Visit 1 confirmed by a repeated measurement within 3 working days. Hepatitis B surface antigen (HBsAg) positive. Hepatitis C antibody test (anti-HCV positive). Clinically significant laboratory abnormalities in the opinion of the researcher.
• Congestive heart failure requiring pharmacological treatment.
• A history of: Type 1 diabetes, diabetes that is the result of pancreatic injury or secondary forms of diabetes, eg, Cushing´s syndrome and acromegaly. Acute metabolic diabetic complications such as ketoacidosis or hyperosmolar condition (coma) in the last 6 months. Liver disease, such as cirrhosis or active chronic hepatitis B or C.
• Any of the following in the last 6 months: Myocardial infarction (MI) (if the ECG of Visit 1 reveals patterns consistent with an IM and the date of the event cannot be determined, then the patient can enter the study at discretion of the researcher and the sponsor). Unstable angina. Coronary artery bypass surgery or percutaneous coronary intervention. Stroke
• Any of the following ECG abnormalities: Torsades de pointes, clinically relevant and sustained ventricular tachycardia or ventricular fibrillation. Second degree AV block (Mobitz 1 and 2). Third degree AV block. Prolonged QTc (> 500 ms).
• Treatment with any oral antidiabetic therapy other than metformin within 3 months prior to Visit 1.
• Chronic insulin treatment (> 4 weeks of treatment in the absence of an intercurrent disease) in the last 6 months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified