Safety and Efficacy Study to Compare Vildagliptin to Pioglitazone as Adding on Metformin in Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Intervention: vildagliptin; Pioglitazone
Intervention description: vildagliptin 50mg bid for 16 weeks; Pioglitazone 15mg bid for 16 weeks
Intervention MeSH terms: Pioglitazone; Vildagliptin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 287.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: vildagliptin; metformin

Summary:

      The purpose of this study is to compare the effect of 16 weeks treatment with vildagliptin to
      pioglitazone as add-on the therapy to metformin in patients with type 2 diabetes inadequately
      controlled with metformin monotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age in the range of 18 to 80 years

          2. HbA1c 7 to 11%

          3. FPG < 270 mg/dL (15 mmol/L);

          4. Agreement to maintain prior diet & exercise

          5. Written informed consent to participate in the study

        Exclusion criteria:

          1. Type 1 diabetes or Any kind of secondary diabetes

          2. Pregnant or lactating women

          3. Acute infections which may affect blood glucose control within 4 weeks prior to visit
             1.

          4. Significant diabetes complications e.g., symptomatic autonomic neuropathy or
             gastroparesis

          5. Previous history of severe cardiovascular disease such as

               1. Torsades de Pointes, sustained and clinically relevant ventricular tachycardia,
                  or ventricular fibrillation

               2. Percutaneous coronary intervention within the past 3 months

          6. Any of the following within the past 6 months

               1. Myocardial infarction (MI) (if the visit 1 ECG reveals patterns consistent with
                  an MI and the date of the event cannot be determined, then the patient can enter
                  the study at the discretion of the investigator and the sponsor)

               2. Coronary artery bypass surgery

               3. Unstable angina

               4. Stroke

          7. Congestive heart failure (NYHA class I to IV)

          8. Liver disease such as cirrhosis or chronic active hepatitis

          9. Known sensitivity to pioglitazone, rosiglitazone, or similar drugs

         10. Chronic insulin treatment (> 4 weeks of treatment in the absence of an intercurrent
             illness) within the past 6 months

         11. Chronic oral or parenteral corticosteroid treatment (> 7 consecutive days of
             treatment) within 8 weeks prior to visit 1

         12. Any of the following laboratory abnormalities

               1. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) greater than 2.5
                  times the upper limit of the normal range at visit 1

               2. Direct bilirubin greater than 1.3 times the upper limit of the normal range at
                  visit 1

               3. Serum creatinine levels > 2.5 mg/dL (220 μmol/L) at visit 1

               4. Clinically significant thyroid-stimulating hormone (TSH) outside normal range at
                  visit 1