MedTrace Logo

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

NCT05353686 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2022-04-29

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Biomapas

    collaborator UNKNOWN

  • Pila Pharma

    lead INDUSTRY

Principal Investigators

  • Dorte X Gram, PhD · Pila Pharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-25
Primary Completion
2019-12-19
Completion
2019-12-19

Countries

  • Lithuania

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05353686 on ClinicalTrials.gov