Health Condition 1: E113- Type 2 diabetes mellitus with ophthalmic complications
Conditions
Interventions
Intervention1: Hydroxychloroquine: 400 mg/day tablets for 52 weeks
Control Intervention1: Teneligliptin: 20 mg/day tablets for 52 weeks
Control Intervention2: Teneligliptin: 20 mg/day tablets for 52 w
Sponsors
IPGMER and SSKM Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female patients aged between >=18 and 2. Type 2 diabetes with HbA1c between >=7% and 3. Mild to severe NPDR (DRSS levels score >= 20 and 4. Best corrected visual acuity-early treatment diabetic retinopathy study (BCVA ETDRS) letter score in the study eye of >=65 letters [approximate Snellen equivalent of >=0.4 (20/50)] 5. Central foveal thickness (CFT) 6. Patients with body weight >= 60 Kg 7. Patients able to understand and willing to fully comply with study procedures and restrictions 8. Patient ready to give informed consent to participate in the study, in accordance with the International Conference for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), Good Clinical Practice (GCP) Guidelines, before completing any study related procedures
Exclusion criteria
Exclusion criteria: 1. Uncontrolled hyperglycemia i.e FPG >240 mg/dL 2. Patients with Type 1 diabetes 3. Presence of diabetic macular edema (DME) threatening the center of the macula in the study eye 4. Evidence of retinal neovascularization on clinical examination 5. Any prior focal or grid laser photocoagulation, prior panretinal photocoagulation (PRP) or refractive surgery in the study eye 6. Any prior systemic anti-VEGF treatment or prior intraocular steroid injection in the study eye within 3 months from enrollment. 7. Current anterior segment neovascularization (ASNV), vitreous hemorrhage, or tractional retinal detachment diagnosed by SD-OCT and color and red-free fundus photography, visible at the screening assessments in the study eye. 8. Concomitant retinal disease due to causes other than diabetic microangiopathy. 9. Patients with recent glaucoma and cataract surgery 10. Patients with dilatation of the pupil 11. Patients with recent cardiovascular accident or myocardial infarction stroke or has undergone coronary artery bypass surgery, percutaneous transluminal coronary angioplasty or transient ischemic attack, or history of congestive heart failure, or unstable angina or edema (Due to Cardio Vascular event) 12. Patients with DBP >100 mmHg and/or SBP >160 mmHg with or without medication 13. Patients with endocrine disorder other than Type 2 diabetes mellitus 14. Patients with eGFR 15. Patients with abnormal liver function (SGOT, SGPT, total bilirubin, or alkaline phosphatase >2.5 times the upper limit of normal values) or active liver disease or patients with CPK >2.5 times the upper limit of normal value 16. Patients with diseases of blood or hematopietic organs or female patients with Hb 17. Patients with history of myalgia, aplastic anemia or agranulocytosis, granulocytopenia, psoriasis, porphyria, rash, scaling, scaling eczema, and G6PD deficiency 18. Patient with history of symptomatic autonomic neuropathy 19. Patients with chronic gastroparesis, active gastrointestinal disorders (gastric and duodenal ulcer) 20. Patient with known history of diabetic ketoacidosis 21. Patients with hypoglycemia unawareness (Patients whose blood glucose levels fall below 70 mg/dL but they do not feel any symptoms of hypoglycemia) 22. Patients with malignancy and planned radiological examinations requiring administration of contrasting agents 23. Patients with malabsorption and pancreatitis 24. Patients with dementia or other cognitive impairment prohibiting informed consent 25. Patients with known history of HIV1/HIV2/Hepatitis B or C infection or syphilis infection 26. Patients with any other clinically significant abnormalities interfering with assessment of disease under evaluation 27. Patients with antihypertensive treatment, unless administered at stable dosage for at least 3 months before the start of the study 28. Patients with hemorrheological, vasoactive drugs and antithrombotics except acetylsalicylic acid at stable dosage 29. Patient who had any other illness for which hydroxychloroquine was indicated (such as rheumatoid arthritis, systemic lupus erythematosus [SLE]) 30. Patients receiving/requiring insulin 31. Patients re
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate and compare proportion of patients who have worsening by â?¥2 steps from baseline on the DRSS score at Week 52 in the study groups.Timepoint: at Week 52 from baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate and compare mean change in the HbA1c levelTimepoint: at Week 24 and Week 52 from baseline between and within treatment groups;To assess safety and tolerability of study medications based on incidence of adverse events (AEs), changes in laboratory parameters, and incidence of hypoglycemiaTimepoint: throughout the duration of study;To compare the percentage of patients requiring Panretinal Photocoagulation (PRP) (scatter) laser, Focal and/or Grid Laser and Intravitreal anti-VEGF TherapyTimepoint: at the end of Week 24 and Week 52 from baseline between treatment groups;To evaluate and compare mean change in the 2 hour postprandial plasma glucose (PPG)Timepoint: at Week 24 and Week 52 from baseline between and within treatment groups;To evaluate and compare mean change in the Fasting plasma glucose (FPG)Timepoint: at Week 24 and Week 52 from baseline between and within treatment groups | — |
Countries
India
Contacts
Public ContactDr Subhankar Chowdhury
IPGME&R and SSKM Hospital
Outcome results
None listed