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A multicenter, randomized, double-blind, placebo-controlled, parallel group, phase III clinical trial of Insugin (Liquid Insulin Mouth Rinse) for Type 2 diabetes patients

Trial Profile

A multicenter, randomized, double-blind, placebo-controlled, parallel group, phase III clinical trial of Insugin (Liquid Insulin Mouth Rinse) for Type 2 diabetes patients

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 05 Jul 2019

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At a glance

  • Drugs Insulin (Primary)
  • Indications Type 2 diabetes mellitus
  • Focus Registrational; Therapeutic Use
  • Sponsors EastGate Biotech

Most Recent Events

  • 26 Jun 2019 According to an EastGate Biotech media release, the company has filed an application with the Drug Regulatory Authority of Pakistan (DRAP) and Ministry of National Health Services to initiate a Phase III clinical study for Insugin. The application requests the dosing of 200 Type 2 diabetic patients in order to achieve statistically significant results for regulatory approval of Insugin in Pakistan. EastGate is considering dosing as many as 500 patients for inclusion in the study.
  • 20 Jun 2019 New trial record
  • 15 May 2019 According to an EastGate Biotech media release, this study will be conducted in joint venture with Genome Pharma/Origin Pharma.

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