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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Pharmacokinetics; Efficacy; Safety
• Intervention / Treatment: Drug: Placebo; Drug: XEN-D0501

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Phase 2

Contacts and Locations

Study Locations

• Lithuania
  • Jonava, Lithuania, LT-55201
    • Kristavita, JSC
  • Kaunas, Lithuania, LT-44175
    • "Auki sveikas" ("A klinika")
  • Kaunas, Lithuania, LT-49449
    • Saules Seimos Medicinos Centras, JSC
  • Kaunas, Lithuania, LT-51270
    • Kaunas City Polyclinic / Dainava Outpatient Clinic
  • Kedainiai, Lithuania, LT-57164
    • Kedainiai Hospital / Outpatient Department
  • Klaipeda, Lithuania, LT-92304
    • A. Navickas Outpatient Clinic
  • Vilnius, Lithuania, LT-04318
    • Karoliniskiu Outpatient Clinic
  • Vilnius, Lithuania, LT-08661
    • Vilnius University Hospital Santaros Clinics / Family Center Department
  • Vilnius, Lithuania, LT-08661
    • Vilnius University Hospital Santaros Clinics
  • Vilnius, Lithuania, LT-09112
    • Vaidotas Urbanavicius Sole Proprietary Enterprise

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 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
2. Diagnosis of type 2 diabetes mellitus
3. In treatment with a stable metformin dose during the last three months, but no other anti-diabetic drugs
4. HbA1C (glycosylated haemoglobin A1C): 6.5-10 %
5. Age above 25

Exclusion Criteria:

1. 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.
2. A subject who has a clinically significant abnormal ECG at screening, as judged by the investigator.
3. A subject who has participated in any other trials involving investigational products within the 3 months preceding the start of dosing.
4. A subject who has donated any blood or plasma in the past month or in excess of 500 mL within 1 month preceding screening.
5. A subject who has a significant history of alcoholism or drug/chemical abuse as per investigator's judgement.
6. 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.
7. Surgery or trauma with significant blood loss within the last 2 months prior to dosing.
8. A subject with a clinically significant abnormal haematology or biochemistry tests at screening visit, as judged by the Investigator considering the underlying disease.
9. Current treatment with drugs known to interfere with glucose metabolism such as systemic corticoids and monoamine oxidase inhibitors (MAO) inhibitors.
10. 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.
11. Previous participation (randomisation) in this trial.
12. Any condition that would interfere with trial participation or evaluation of results, as judged by the investigator and/or sponsor
13. Recurrent major hypoglycaemia or hypoglycaemic unawareness, as judged by the Investigator.
14. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Subjects in the placebo arm will receive an oral tablet containing no active drug twice daily	Drug: Placebo; Subjects in the placebo arm will receive an oral tablet containing no active drug twice daily
Active Comparator: XEN-D0501; Subjects in the XEN-D050 arm will receive an oral tablet containing 4 mg/tablet of IMP, twice daily	Drug: XEN-D0501; Subjects in the XEN-D0501 arm will receive an oral tablet containing 4 mg/tablet of IMP twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary endpoint	Fasting blood glucose after four weeks of bi-daily dosing of XEN-D0501	4 weeks of treatment

Collaborators and Investigators

• Sponsor: Pila Pharma
• Collaborators: Biomapas
• Investigators: Study Director: Dorte X Gram, PhD, Pila Pharma

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2019
• Primary Completion (Actual): December 19, 2019
• Study Completion (Actual): December 19, 2019

Study Registration Dates

• First Submitted: April 25, 2022
• First Submitted That Met QC Criteria: April 25, 2022
• First Posted (Actual): April 29, 2022

Study Record Updates

• Last Update Posted (Actual): April 29, 2022
• Last Update Submitted That Met QC Criteria: April 25, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: PP-CT02; 2018-001880-22 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No