Efficacy of Dapagliflozin in Diabetes Associated Peripheral Neuropathy (DINE)
Diabetic Peripheral Neuropathy
About this trial
This is an interventional treatment trial for Diabetic Peripheral Neuropathy focused on measuring Diabetes, SGLT2 inhibitors, dapagliflozin, CCM, IENFD, Skin Biopsy, Peripheral Neuropathy, Corneal confocal microscopy, intraepithelial nerve fiber density, Diabetic Sensory Polyneuropathy(DSPN), DSPN
Eligibility Criteria
Inclusion Criteria:
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Type 2 Diabetes Mellitus < 5 years duration
Age >18yrs
Presence of neuropathy at baseline (accessed by Michigan Neuropathy Screening Instrument score >7 )
estimated Glomerular Filtration rate (eGFR) > 45ml/min/m2
HBA1c < 9
Exclusion Criteria:
Untreated Hypothyroidism
Patients currently on SGLT2 inhibitors History of Leprosy
Patients with history of and current foot ulcers
Presence of Peripheral Vascular disease(ABI <0.9)
B12(<200 pg/ml)/ Folate (<4.6 ng/ml)
History of alcohol abuse (>2 standard drink per day for males and >1 standard drink for females)
Factors affecting corneal nerves( severe dry eyes, severe corneal dystrophies, ocular trauma or surgery in the preceding 6 months)
Negative consent
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Sites / Locations
- Department of Endocrinology, PGIMERRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
The Drug Arm
The Placebo Arm
Dapagliflozin 10 milligram Once a day 1 year
Metformin 1gram Per Oral Twice a day Glimepiride 2 milligram oral twice a day Dipeptidyl peptidase 4 inhibitors (DPP4 inhibitors)