Effect of 13-Week Treatment With Vildagliptin as Add-On Therapy to Improve Glucose Variability in Type II Diabetes

A Multicenter, Double-Blind, Randomized, Parallel-Group Placebo-Controlled Study to Compare the Effect of 13-Week Treatment With Vildagliptin as Add-On Therapy to Improve Glucose Variability in Type 2 Diabetes Mellitus Patients Inadequately Controlled With Insulin.

The purpose of the study is to assess if the addition of vildagliptin as add-on therapy improves glucose variability in type 2 diabetes mellitus (T2DM) patients inadequately controlled with insulin, with special emphasis in hypoglycemic episodes measured by continuous glucose monitoring.

Inclusion Criteria:

1. Informed consent read and signed before any protocol procedure.
2. Free will to sign the informed consent.
3. Male and female between 18 and 80 years. If female, patient must be non-fertile or of childbearing potential using a medically approved birth control method.
4. Type 2 diabetes mellitus
5. Patient under insulin treatment within 3 years with stable insulin NPH (Neutral ProtamineHagedorn) regimen at dose of at least 20 UI/day up to 40 UI/day for a minimum of 4 weeks prior to enrolment, only NPH and glargine insulin are allowed.
6. HbA1c between 7.5 to 9%.
7. Fasting plasma glucose (FPG) less than 270 mg/dL.
8. Body mass index (BMI) between 20 to 35 kg/m2.
9. Free willing to take the vildagliptin tablets during the study.

Exclusion Criteria

1. Pregnant or lactating female or without birth control method if of childbearing potential.
2. Type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, e.g., Cushing's syndrome.
3. Acute cardiovascular complications or metabolic complications within the past 4 months.
4. History cerebrovascular disease during the last year.
5. History of Torsades de Points, ventricular tachycardia or ventricular fibrillation.
6. Ischemic heart disease (e.g. myocardial infarction, unstable angina, coronary artery bypass surgery).
7. Congestive heart failure requiring pharmacologic treatment.
8. Any known serious heart condition.
9. ALT and/or AST greater than three times the upper limit of the normal range.
10. Serum creatinine levels greater than 1.5 mg/dL
11. Malignancy including leukemia and lymphoma within the last 5 years

Other inlcusion/exclusion criteria may apply