Safety and Efficacy Study to Compare Vildagliptin to Pioglitazone as Adding on Metformin in Type 2 Diabetes

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pusan National University Hospital
• Treatments: Metformin; Pioglitazone; Vildagliptin

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