NCT05353686

A Trial Investigating the Effect of 4 Weeks Dosing of XEN-D0501 on Blood Glucose Reduction in Patients With Diabetes

A Randomised, Double-blind, Placebo-controlled, Parallel-group Trial Investigating the Effect of 4 Weeks Bi-daily Dosing of XEN-D0501 on Blood Glucose Reduction as add-on to Metformin in Patients With Diabetes

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Pila Pharma · Industry
• Sex: All
• Age: 25 Years
• Healthy volunteers: Not accepted

Summary

This is a randomised, double-blind, placebo-controlled, parallel-group trial investigating the effect of 4 weeks bi-daily dosing of XEN-D0501 on blood glucose reduction as add-on to metformin in patients with diabetes mellitus type 2 where life style changes and treatment with metformin has failed to effectively reduce blood glucose concentrations.

Conditions

• Efficacy
• Safety
• Pharmacokinetics
• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	Placebo	Subjects in the placebo arm will receive an oral tablet containing no active drug twice daily
DRUG	XEN-D0501	Subjects in the XEN-D0501 arm will receive an oral tablet containing 4 mg/tablet of IMP twice daily

Timeline

• Start date: 2019-02-25
• Primary completion: 2019-12-19
• Completion: 2019-12-19
• First posted: 2022-04-29
• Last updated: 2022-04-29

Locations

10 sites across 1 country: Lithuania