Acarbose, Endothelial Function, Gemigliptin, Type 2 Diabetes
Conditions
Brief summary
This is a phase 4, single center, randomized, open-labeled study. The primary objective of the study is to compare effect of gemigliptin and acarbose on endothelial function. Subjects are randomized to gemigliptin or acarbose group and maintained intial treatment for 4 weeks.
Interventions
DRUGGemigliptin
Gemigliptin for 4 weeks
DRUGAcarbose
Acarbose for 4 weeks
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* age: 20-80yrs * patients with type 2 diabetes (duration of diabetes \>=3 months) * HbA1c :\>7.0 and \<=9.0% on metformin monotherapy * no changes on medications during recent 3 months.
Exclusion criteria
* patients with type 1 diabetes * history of medications including α-glucosidase inhibitor, glinide, GLP-1 analogue, other DPP-4 Inhibitors, or insulin during recent 3 months. * history of acute diabetic complication, acute coronary events, or coronary bypass surgery/interventions during recent 6 months. * patients with congestive heart failure (NYHA II\ IV) or clinically significant ventricular arrhythmia * serum ALT or AST\> 2.5 x upper normal range * serum direct bilirubin \> 1.3 x upper normal range * serum creatinine \> (men) 1.5 mg/dL, (women)\>1.4 mg/dL * smoker * pregnant women, or breast-feeding women * medication with acetylsalicylic acid or vitamin K antagonist
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| endothelial function (reactive hyperemic index) | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Fasting plasma glucose | 4 weeks |
| Postprandial 2hour glucose | 4 weeks |
| Glycated albumin | 4 weeks |
Countries
South Korea
Contacts
Primary ContactMin Kyong Moon
Backup ContactBo Kyung Koo
Outcome results
None listed