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Clinical Trials/CTRI/2022/06/043236
CTRI/2022/06/043236
Recruiting
Phase 3

Efficacy of dapafliflozin in diabetic peripheral neuropathy, a randomized controlled trial - DINE

Postgraduate Institute of Medical Education Research0 sites0 target enrollmentTBD
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ConditionsHealth Condition 1: E114- Type 2 diabetes mellitus with neurological complications

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Health Condition 1: E114- Type 2 diabetes mellitus with neurological complications
Sponsor
Postgraduate Institute of Medical Education Research
Status
Recruiting
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
3 years ago
Study Type
Interventional

Investigators

Sponsor
Postgraduate Institute of Medical Education Research

Eligibility Criteria

Inclusion Criteria

  • •1\.Type 2 Diabetes Mellitus 5\-10 years duration
  • •2\.Age 18yrs\- 75 yrs
  • •3\.Presence of neuropathy at baseline (MNSI score \>4 )
  • •4\.eGFR \> 30ml/min/m2
  • •5\.HBA1c between 7\-10

Exclusion Criteria

  • •1\.Untreated Hypothyroidism
  • •2\.Patients currently on SGLT2 inhibitors
  • •3\.History of Leprosy
  • •4\.Patients with current foot ulcer
  • •5\.Presence of Peripheral Vascular disease with critical limb ischemia (ABI \<0\.7 )
  • •6\.History of alcoholism ( \>2 and \>1 standard drink per day for male and female respectively)
  • •7\.Factors affecting corneal nerves (severe dry eyes, severe corneal dystrophies, ocular trauma or surgery in the preceding 6 months)
  • •Negative consent

Outcomes

Primary Outcomes

Not specified

Similar Trials

Unknown
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