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

NCT05353686 | Completed Phase 2

• 2 other identifiers: PP-CT022018-001880-22
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 10

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.

Conditions

Efficacy; Safety; Pharmacokinetics; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Primary endpoint

  Fasting blood glucose after four weeks of bi-daily dosing of XEN-D0501

  4 weeks of treatment

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Subjects in the placebo arm will receive an oral tablet containing no active drug twice daily

Drug: Placebo

XEN-D0501

ACTIVE COMPARATOR

Subjects in the XEN-D050 arm will receive an oral tablet containing 4 mg/tablet of IMP, twice daily

Drug: XEN-D0501

Interventions

Placebo DRUG

Subjects in the placebo arm will receive an oral tablet containing no active drug twice daily

Placebo

XEN-D0501 DRUG

Subjects in the XEN-D0501 arm will receive an oral tablet containing 4 mg/tablet of IMP twice daily

XEN-D0501

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• Previous participation (randomisation) in this trial.
• Any condition that would interfere with trial participation or evaluation of results, as judged by the investigator and/or sponsor
• Recurrent major hypoglycaemia or hypoglycaemic unawareness, as judged by the Investigator.
• Females of childbearing potential (i. e. not post-menopausal ≥ 12 months or surgically sterilised) who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures include sterilisation, hormonal intrauterine devices, oral hormonal contraceptives (p-pills), implantants, transdermal patches, p-ring or depot injection, sexual abstinence or vasectomised partner). A male subject who is sexually active and has not been surgically sterilised must be informed that he must ensure that his partner practices effective contraception, as stated above, or he must refrain from sexual intercourse during the trial and until 90 days after completion of the trial. This is to prevent the possibility of a pregnancy from spermatocytes that can potentially be damaged by trial medication.

Sponsors & Collaborators

• Pila Pharma: lead
• Biomapas: collaborator

Study Sites (10)

Kristavita, JSC

Jonava, LT-55201, Lithuania

Location

"Auki sveikas" ("A klinika")

Kaunas, LT-44175, Lithuania

Location

Saules seimos medicinos centras, JSC

Kaunas, LT-49449, Lithuania

Location

Kaunas City Polyclinic / Dainava Outpatient Clinic

Kaunas, LT-51270, Lithuania

Location

Kedainiai Hospital / Outpatient Department

Kėdainiai, LT-57164, Lithuania

Location

A. Navickas Outpatient Clinic

Klaipėda, LT-92304, Lithuania

Location

Karoliniskiu Outpatient Clinic

Vilnius, LT-04318, Lithuania

Location

Vilnius University Hospital Santaros Clinics / Family Center Department

Vilnius, LT-08661, Lithuania

Location

Vilnius University Hospital Santaros Clinics

Vilnius, LT-08661, Lithuania

Location

Vaidotas Urbanavicius Sole Proprietary Enterprise

Vilnius, LT-09112, Lithuania

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Dorte X Gram, PhD

  Pila Pharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The treatment is blinded for subjects, care provider and investigator.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a 4 weeks randomised, double-blind, placebo-controlled, parallel-group, prospective trial. Each subject will be randomised to 1 out of 2 possible treatment arms and treated for four weeks.

Study Record Dates

• First Submitted: April 25, 2022
• First Posted: April 29, 2022
• Study Start: February 25, 2019
• Primary Completion: December 19, 2019
• Study Completion: December 19, 2019
• Last Updated: April 29, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

LI (10)