Status:
COMPLETED
Safety and Efficacy Study to Compare Vildagliptin to Pioglitazone as Adding on Metformin in Type 2 Diabetes
Lead Sponsor:
Pusan National University Hospital
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief 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 w...
Detailed Description
Type 2 diabetes mellitus (T2DM) is a chronic progressive disease characterized by hyperglycemia that result from pancreatic islet dysfunction. Presently available oral antihypoglycemic drug improves g...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Age in the range of 18 to 80 years
- HbA1c 7 to 11%
- FPG \< 270 mg/dL (15 mmol/L);
- Agreement to maintain prior diet \& exercise
- Written informed consent to participate in the study
- Exclusion criteria:
- Type 1 diabetes or Any kind of secondary diabetes
- Pregnant or lactating women
- Acute infections which may affect blood glucose control within 4 weeks prior to visit 1.
- Significant diabetes complications e.g., symptomatic autonomic neuropathy or gastroparesis
- Previous history of severe cardiovascular disease such as
- Torsades de Pointes, sustained and clinically relevant ventricular tachycardia, or ventricular fibrillation
- Percutaneous coronary intervention within the past 3 months
- Any of the following within the past 6 months
- 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)
- Coronary artery bypass surgery
- Unstable angina
- Stroke
- Congestive heart failure (NYHA class I to IV)
- Liver disease such as cirrhosis or chronic active hepatitis
- Known sensitivity to pioglitazone, rosiglitazone, or similar drugs
- Chronic insulin treatment (\> 4 weeks of treatment in the absence of an intercurrent illness) within the past 6 months
- Chronic oral or parenteral corticosteroid treatment (\> 7 consecutive days of treatment) within 8 weeks prior to visit 1
- Any of the following laboratory abnormalities
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST) greater than 2.5 times the upper limit of the normal range at visit 1
- Direct bilirubin greater than 1.3 times the upper limit of the normal range at visit 1
- Serum creatinine levels \> 2.5 mg/dL (220 μmol/L) at visit 1
- Clinically significant thyroid-stimulating hormone (TSH) outside normal range at visit 1
Exclusion
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
287 Patients enrolled
Trial Details
Trial ID
NCT01882907
Start Date
December 1 2009
End Date
March 1 2013
Last Update
March 21 2019
Active Locations (15)
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1
Busan Saint Mary's Medical Center
Busan, South Korea
2
Dong-AUniversity Medical Center
Busan, South Korea
3
Inje University Baik Hospital
Busan, South Korea
4
Kosin University Hospital
Busan, South Korea