Efficacy of Dapagliflozin in Diabetes Associated Peripheral Neuropathy

NCT05162690 | Unknown Phase 2 DMC

• 1 other identifier: PGIMER1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetic Peripheral Neuropathy

Keywords

Diabetes; SGLT2 inhibitors; dapagliflozin; CCM; IENFD; Skin Biopsy; Peripheral Neuropathy; Corneal confocal microscopy; intraepithelial nerve fiber density; Diabetic Sensory Polyneuropathy(DSPN); DSPN

Outcome Measures

Primary Outcomes (1)

• Intraepithelial nerve fiber density

  mean change in intraepithelial nerve fiber density(F/mm) will be evaluate at baseline and after 24 weeks of treatment with dapagliflozin.

  24 weeks

Secondary Outcomes (1)

• corneal nerve fiber density

  24 weeks

Study Arms (2)

The Drug Arm

ACTIVE COMPARATOR

Dapagliflozin 10 milligram Once a day 1 year

Drug: Dapagliflozin 10 milligram

The Placebo Arm

PLACEBO COMPARATOR

Metformin 1gram Per Oral Twice a day Glimepiride 2 milligram oral twice a day Dipeptidyl peptidase 4 inhibitors (DPP4 inhibitors)

Other: Placebo

Interventions

Dapagliflozin 10 milligram DRUG

10mg per day of Dapagliflozin will be given to the patients

The Drug Arm

Placebo OTHER

Metformin DPP4 inhibitors

The Placebo Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

Department of Endocrinology, PGIMER

Chandigarh, 160012, India

RECRUITING

Related Publications (1)

• Adhikari U, Gad H, Chatterjee D, Malhotra C, Bhadada SK, Malik RA, Rastogi A. Dapagliflozin for Small Nerve Fibre Regeneration in Diabetic Peripheral Neuropathy: A Randomised Controlled Study (DINE). J Peripher Nerv Syst. 2025 Mar;30(1):e70011. doi: 10.1111/jns.70011.

  PMID: 40044634 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Peripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Ashu Rastogi, DM

  PGIMER, India

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashu Rastogi, MD, DM

CONTACT

9781001046; rastogi.ashu@pgi.ac.in

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 27, 2021
• First Posted: December 17, 2021
• Study Start: May 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: June 7, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)