Efficacy of Dapagliflozin in Diabetes Associated Peripheral Neuropathy

Sponsor
Post Graduate Institute of Medical Education and Research, Chandigarh
Study ID
NCT05162690
Phase
PHASE2/PHASE3
Status
Unknown

Conditions

  • Diabetic Peripheral Neuropathy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin 10 milligram — DRUG
    10mg per day of Dapagliflozin will be given to the patients
  • Placebo — OTHER
    Metformin DPP4 inhibitors

Study Details

Diabetic peripheral neuropathy(DPN) is a length dependent axonal neuropathy that affects at least 50% of patients with diabetes mellitus. DPN is often asymptomatic during the early stages of diabetes ,however, once symptoms and overt deficits have developed, it cannot be reversed. Early diagnosis of neuropathy is important because early diagnosis and timely intervention might prevent the development and progression of diabetic neuropathy.Though glycemic control has been shown to prevent the progression of diabetic microvascular complications including diabetic peripheral neuropathy in Type I DM, such strict glycemic control has not shown to improve diabetic peripheral neuropathy in Type 2 DM. There are only few animal studies conducted so far which have shown that the use of SGLT2 inhibitors prevents the progression of diabetic peripheral neuropathy.Thus the investigators postulate that the use of SGLT2 inhibitor in patients with Type 2 Diabetes Mellitus might be beneficial in the prevention of progression of diabetic peripheral neuropathy as well as reverse it.

Key Dates

Start date
May 1, 2022
Status verified
Jun 2022
Primary completion
Dec 31, 2023
Completion
Dec 31, 2023

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: The Drug Arm
    Dapagliflozin 10 milligram Once a day 1 year
  • Placebo Comparator: The Placebo Arm
    Metformin 1gram Per Oral Twice a day Glimepiride 2 milligram oral twice a day Dipeptidyl peptidase 4 inhibitors (DPP4 inhibitors)

Primary Outcome Measure

Intraepithelial nerve fiber density [ Time Frame: 24 weeks ]

Central Contacts

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