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A Single-dose Trial to Investigate the Safety and Tolerability of XEN-D0501 in Patients With Diabetes Mellitus Type 2

NCT03278158 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2019-03-22

No results posted yet for this study

Summary

This is a single-dose dose escalation trial in a randomised, single-blind, placebo-controlled group-comparison design to investigate the safety and tolerability of XEN-D0501 in subjects with diabetes mellitus type 2 where life style changes and treatment with metformin has failed to effectively reduce blood glucose concentrations.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Placebo

Subjects in the placebo arm will receive a single oral tablet containing no active drug.

DRUG

XEN-D0501, 1 mg/tablet

Subjects in this arm will receive a single oral tablet of XEN-D0501, 1 mg/tablet

DRUG

XEN-D0501, 2 mg/tablet

Subjects in this arm will receive a single oral tablet of XEN-D0501, 2 mg/tablet

DRUG

XEN-D0501, 4 mg/tablet

Subjects in this arm will receive a single oral tablet of XEN-D0501, 4 mg/tablet

DRUG

XEN-D0501, 8 mg/tablet

Subjects in this arm will receive a single oral tablet of XEN-D0501, 8 mg/tablet

Sponsors & Collaborators

  • Pila Pharma

    lead INDUSTRY

Principal Investigators

  • Henning Beck-Nielsen, Dr. · Odense University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-18
Primary Completion
2018-11-13
Completion
2018-11-13

Countries

  • Denmark

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 NCT03278158 on ClinicalTrials.gov