AzTrials
AzTrials

EfficacyPhase 2NCT05353686

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

A Phase 2 study testing XEN-D0501 in people with Efficacy and Safety, run by Pila Pharma at 10 sites in Lithuania.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 25 years and older
Conditions the study is for
Efficacy, Safety, Pharmacokinetics
What is being tested?
XEN-D0501
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
54 participants
Where
10 sitesLithuania
Study dates
25 Feb 2019to 19 Dec 2019
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 14Show fewer
  • 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.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

Lithuania10 sites

  • Kristavita, JSC

    Jonava, LT-55201

  • "Auki sveikas" ("A klinika")

    Kaunas, LT-44175

  • Saules seimos medicinos centras, JSC

    Kaunas, LT-49449

  • Kaunas City Polyclinic / Dainava Outpatient Clinic

    Kaunas, LT-51270

  • Kedainiai Hospital / Outpatient Department

    Kėdainiai, LT-57164

  • A. Navickas Outpatient Clinic

    Klaipėda, LT-92304

  • Karoliniskiu Outpatient Clinic

    Vilnius, LT-04318

  • Vilnius University Hospital Santaros Clinics / Family Center Department

    Vilnius, LT-08661

  • Vilnius University Hospital Santaros Clinics

    Vilnius, LT-08661

  • Vaidotas Urbanavicius Sole Proprietary Enterprise

    Vilnius, LT-09112

Other trials in Lithuania

About this study

Official title: 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.

Being tested
Placebo, XEN-D0501
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

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

  • XEN-D0501Drug

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

Study groups in NCT05353686
Study groupRoleWhat they receive
PlaceboPlacebo comparatorSubjects in the placebo arm will receive an oral tablet containing no active drug twice daily
Receives: Drug: Placebo
XEN-D0501Active comparatorSubjects in the XEN-D050 arm will receive an oral tablet containing 4 mg/tablet of IMP, twice daily
Receives: Drug: XEN-D0501

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary endpoint

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

    Measured: 4 weeks of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2022
  2. Study start25 Feb 2019
  3. Primary completion19 Dec 2019
  4. Study completion19 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05353686
Sponsor's protocol ID
PP-CT02
Other IDs
2018-001880-22, 2018
Status last verified
Apr 2022
First submitted
25 Apr 2022
Last updated
29 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing XEN-D0501 in people with Efficacy and Safety, run by Pila Pharma at 10 sites in Lithuania.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary endpoint (time frame: 4 weeks of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05353686.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in