Effects of anti-hyperglycemic agents on diabetic retinopathy
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0002681
- Lead Sponsor
- Ajou University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 80
1) Age 20-80 years
2) Type 2 diabetes
3) HbA1c 7%=HbA1c=10%
4) BMI 20-35 kg/m2
5) background medications: metformin 500~2000mg, glimepiride = 4mg/day, or gliclazide = 60mg/day
6) mild to moderate non-proliferative diabetic retinopathy (ETDRS 20-43, microaneurysm or mild to moderate NPDR)
7) A person who is able to complete the written consent before the start of the clinical trial and comply with the requirements of the clinical trial
1) Type 1 diabetes or patients with acute or chronic metabolic acidosis and history of diabetic ketoacidosis
2) patients requiring ophthalmologic treatment with macular edema (central foveal thickness of > 275 µm on OCT) or severe NPDR
3) proliferative diabetic retinopathy
4) patients with receiving intraocular surgery or vitreoretinal pathyology
5) DPPIV inhibitor, GLP-1 agonist, or fibrate user within 8 weeks
6) hypersensitivity or intolerance of gemigliptin, glimepiride, gliclazide, or metformin
7) history of angioedema by ACE inhibitor or ARB or history of diabetic gastroparesis
8) cardiovascular disease within 6 months
9) chronic kidney disease (creatinine clearance rate <30mL/min)
10) chronic hepatitis B or C (excluding healthy carrier) or liver disease (screening test : ALT < 2.5 x ULN, AST < 2.5 x ULN, ALK < 2.5 x ULN, T.bilirubin <2.5 x ULN)
11) genetic disease (Galactose intolerance, lactase deficiency, glucose-galactose malabsorption syndrome)
12) cerebrovascular disease within 6 months
13) alcohol or drug abuser within 3 months
14) cancer within
15) pregnant or lactating women
17) patients who was judged to be unfit for clinical trial
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method change of hard exudate from baseline or DRSS(diabetic retinopathy severity scale)
- Secondary Outcome Measures
Name Time Method change of central macular thickness on optical coherence tomography;progression on the ETDRS scale (=1step, =2step, =3step);occurance of photocoagulation or vitrectomy;change of HbA1c, FPG, and lipid profile