This is a single center, randomized, double-blind pilot study on patients with Type 2 diabetes. The purpose of this study is to test the effects of vildagliptin (as add-on to metformin) on hepatic insulin clearance, on levels of adipocytokines, metabolic syndrome biomarkers and adipose tissue mRNA expression.
Conditions
Interventions
Product Name: Vildagliptin
Pharmaceutical Form: Tablet
INN or Proposed INN: Vildagliptin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of
Sponsors
Charite Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male, non-fertile female or female of childbearing potential using a medically approved birth control method (Pearl Index 40 mIU/m); 6 weeks post bilateral oophorectomy with or without hysterectomy; post hysterectomy; or sterilized by tubal ligation. • A female of childbearing potential is defined as any woman physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means. • Medically approved birth control method (Pearl index=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating female or female of childbearing potential without a medically approved birth control method (Pearl Index 500 msec) 8. Malignancy including leukemia and lymphoma (not including basal cell skin cancer) within the last 5 years. 9. Liver disease such as cirrhosis or chronic active hepatitis. 10. Chronic insulin treatment (> 4 weeks of treatment in the absence of an intercurrent illness) within the past 6 month. 11. Chronic oral or parenteral corticosteroid treatment (> 7 consecutive days of treatment) within 8 weeks prior to visit 1. 12. Treatment with growth hormone or similar drugs. 13. Treatment with class Ia, Ib and Ic or III anti-arrhythmics. 14. Use of other investigational drugs at visit 1, or within 60 days prior to visit 1. 15. Treatment with cytostatic drugs within the past 3 months. 16. History of active substance abuse (including alcohol) within the past 2 years. 17. Any of the following significant laboratory abnormalities: • ALT, AST greater 2 times the upper limit of the normal range (ULN) at visit 1, confirmed by a repeat measure within 3 working days. • Total bilirubin greater than 2 times ULN and direct bilirubin greater the upper limit of the normal range at visit 1, confirmed by a repeat measure within 3 working days. • At any time during the clinical trial, if ALT and/or AST is greater than or equal to 3 times the ULN without clinical symptoms, the tests must be repeated within 3 days. If confirmed the patient must be discontinued. • At any time during the clinical trial, if ALT and/or AST is greater than or equal to 3 times the ULN, with total bilirubin elevated above the ULN, then the patient must be discontinued immediately • Clinically significant renal dysfunction as indicated by serum creatinine levels = 1.5 mg/dL (132 ?mol/L) males, = 1.4 mg/dL (123 ?mol/L) females, or a history of abnormal creatinine clearance. • Clinically significant TSH values outside of normal range at visit 1. • Clinically significant laboratory abnormalities, confirmed by repeat measurement, other than hyperglycemia, hyperinsulinemia, and glycosuria at visit 1A. • Fasting triglycerides ? 700 mg/dL (7.9 mmol/L) at visit 1. 18. Lack cooperat
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to examine the effects of vildagliptin 50mg twice daily used in combination with metformin in patients with type 2 diabetes on the change of Adiponectin level.;Secondary Objective: The changes in hepatic insulin clearance after 12 weeks of treatment will be examined. The changes in the levels of circulating HMW adiponectin and inflammatory and metabolic synrome biomarkers such as CRP, IL1ß and MCP1 will be measured. Furthermore adipose tissue mRNA expression of GIP induced genes including adiponectin receptors and GIP receptors will be studied. GIP regulated genes have been recently identified by our group after infusion of GIP. The most prominently genes will be treated as GIP marker genes. The efficacy of vildagliptin 50 mg twice daily used in combination with metformin to improve glycemic control will be demonstrated by measurement of HbA1c and fasting plasma glucose. ;Primary end point(s): change in Adiponectin level | — |
Countries
Germany
Outcome results
None listed