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

Pila Pharma10 sites in 1 country54 target enrollmentFebruary 25, 2019

ConditionsEfficacy Safety Pharmacokinetics Diabetes Mellitus, Type 2

InterventionsPlacebo XEN-D0501

DrugsPlacebo XEN-D0501

Overview

Phase: Phase 2
Intervention: Placebo
Conditions: Efficacy
Sponsor: Pila Pharma
Enrollment: 54
Locations: 10
Primary Endpoint: Primary endpoint
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

February 25, 2019

End Date

December 19, 2019

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Pila Pharma

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•The subject must give his/her signed and dated informed consent before any trial-related activities. Trial-related activities are any procedures that would not have been performed during the normal management of the subject
•Diagnosis of type 2 diabetes mellitus
•In treatment with a stable metformin dose during the last three months, but no other anti-diabetic drugs
•HbA1C (glycosylated haemoglobin A1C): 6.5-10 %
•Age above 25

Exclusion Criteria

•A subject with a history of significant multiple drug allergies or with a known or suspected allergy to the trial product or any medicine chemically related to the trial product, as judged by the Investigator.
•A subject who has a clinically significant abnormal ECG at screening, as judged by the investigator.
•A subject who has participated in any other trials involving investigational products within the 3 months preceding the start of dosing.
•A subject who has donated any blood or plasma in the past month or in excess of 500 mL within 1 month preceding screening.
•A subject who has a significant history of alcoholism or drug/chemical abuse as per investigator's judgement.
•A subject with mental incapacity or language barriers which preclude adequate understanding or cooperation, who is unwilling to participate in the trial, or who in the opinion of their general practitioner or the Investigator should not participate in the trial.
•Surgery or trauma with significant blood loss within the last 2 months prior to dosing.
•A subject with a clinically significant abnormal haematology or biochemistry tests at screening visit, as judged by the Investigator considering the underlying disease.
•Current treatment with drugs known to interfere with glucose metabolism such as systemic corticoids and monoamine oxidase inhibitors (MAO) inhibitors.
•Haemoglobin \< 6.2 mmol/l (\<99.8 g/l), total leukocyte count \< 3.0 x 109/l, thrombocytes \<100 x 109/l, serum creatinine levels ≥ 126 μmol/l (male) or ≥ 111 μmol/l (female), bilirubin \> 3 x ULN, alanine aminotransferase \> 2 x the upper limit of normal (ULN), alkaline phosphatase \> 2 x ULN, one re-test within a week is permitted.