Effects of anti-hyperglycemic agents on diabetic retinopathy

A multicenter, randomized, open, parallel, prospective study to investigate the effectiveness of 50mg gemigliptin on diabetic retinopathy in patients with type 2 diabetes

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0002681

Enrollment

Registered

2018-02-02

Start date

2017-08-09

Completion date

Unknown

Last updated

2020-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : control group-monotherapy or combination of metformin, sulfonylurea or/and insulin Intervention group-background medication(metformin, sulfonylurea or/and insulin)+gemigliptin 50mg qd, po drura

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
change of hard exudate from baseline or DRSS(diabetic retinopathy severity scale)	—

Secondary

Measure	Time frame
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	—

Countries

Korea, Republic of

Contacts

Public ContactKwanWoo Lee

Ajou University

Outcome results