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Diabetes Mellitus, Type 2Phase 2NCT03278158

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

A Phase 2 study testing XEN-D0501, 1 mg/tablet, XEN-D0501, 2 mg/tablet and XEN-D0501, 4 mg/tablet in people with Diabetes Mellitus, Type 2, run by Pila Pharma at 1 site in Denmark.

Completed

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

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 30 to 70 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
XEN-D0501, 1 mg/tablet, XEN-D0501, 2 mg/tablet and XEN-D0501, 4 mg/tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
26 participants
Where
1 siteDenmark
Study dates
18 Sep 2017to 13 Nov 2018
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 30 to 70 years
  • 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 metformin, but no other anti-diabetic drugs
  • In treatment with an ACE-inhibitor but no other anti-hypertensive drugs
  • HbA1C (glycosylated haemoglobin A1C) 6.5-10 %
  • Age between 30 and 70 years (both inclusive).

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 supine blood pressure at screening (including those on anti-hypertensives), after resting for 5 min, outside the range of 90-140 mmHg systolic or 50-90 mmHg diastolic (excluding white-coat hypertension; therefore, if a repeated measurement on a second screening visit shows values within the range, the subject can be included in the trial).
  • A subject who is in pharmacological treatment of hypertension if the current treatment includes other than an ACE-inhibitor
  • 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 the 3 months preceding screening.
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  • A subject who has a significant history of alcoholism or drug/chemical abuse as per investigator's judgement, or who has a positive result in the urine drug/alcohol screen at screening visit.
  • A subject who smokes more than 5 cigarettes, or the equivalent, per day and is unable to refrain from smoking during the in-house periods as determined by the Investigator.
  • 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 history of or presence of cancer, or any clinically significant, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological (with the exception of diabetes mellitus type 2 and euthyroid struma), haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders.
  • Cardiac problems defined as: decompensated heart failure (New York Heart Association (NYHA) class III and IV) at any time and/or angina pectoris and/or acute myocardial infarction within the last 12 months.
  • 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.
  • A subject who has proliferative retinopathy or maculopathy, and/or severe neuropathy, in particular autonomic neuropathy, as judged by the Investigator.
  • Haemoglobin < 6.2 mmol/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 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

1 site in 1 country.

Denmark1 site

  • Odense University Hospital

    Odense, 5000

Other trials in Denmark

About this study

Official title: 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 Patients With Diabetes Mellitus Type 2

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.

Being tested
Placebo, XEN-D0501, 1 mg/tablet, XEN-D0501, 2 mg/tablet, XEN-D0501, 4 mg/tablet, XEN-D0501, 8 mg/tablet
Keywords
safety, tolerability
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 a single oral tablet containing no active drug.

  • XEN-D0501, 1 mg/tabletDrug

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

  • XEN-D0501, 2 mg/tabletDrug

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

  • XEN-D0501, 4 mg/tabletDrug

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

  • XEN-D0501, 8 mg/tabletDrug

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

Study groups in NCT03278158
Study groupRoleWhat they receive
PlaceboPlacebo comparatorSubjects in the placebo arm will receive a single oral tablet containing no active drug.
Receives: Drug: Placebo
XEN-D0501, 1 mg/tabletExperimentalSubjects in this arm will receive a single oral tablet of XEN-D0501, 1 mg/tablet
Receives: Drug: XEN-D0501, 1 mg/tablet
XEN-D0501, 2 mg/tabletExperimentalSubjects in this arm will receive a single oral tablet of XEN-D0501, 2 mg/tablet. Discontinued after 2 patients due to good safety. Escalation to higher dose levels in whole study (1, 2 and 4 mg changed to 1, 4 and 8 mg)
Receives: Drug: XEN-D0501, 2 mg/tablet
XEN-D0501, 4 mg/tabletExperimentalSubjects in this arm will receive a single oral tablet of XEN-D0501, 4 mg/tablet
Receives: Drug: XEN-D0501, 4 mg/tablet
XEN-D0501, 8 mg/tabletExperimentalSubjects in this arm will receive a single oral tablet of XEN-D0501, 8 mg/tablet
Receives: Drug: XEN-D0501, 8 mg/tablet

What is being measured

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

  1. Safety and tolerability of single ascending oral doses of XEN-D0501, (1, 2, 4 and 8 mg) versus placebo in type 2 diabetic patients in treatment with metformin (Incidence of adverse events in type 2 diabetic patients)

    Incidence of adverse events in type 2 diabetic patients

    Measured: 1-3 weeks

Timeline

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

  1. First posted11 Sep 2017
  2. Study start18 Sep 2017
  3. Primary completion13 Nov 2018
  4. Study completion13 Nov 2018

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
Each subject will be randomised to one of four treatments, placebo and three different single oral doses of XEN-D0501. Cohorts of 8 patients are run subsequently where of 2 patients receive placebo and 6 patients receive XEN-D0501 beginning with the 1 mg dose followed by the 2, 4 and 8 mg dose groups. Each treatment step will be completed consecutively and progression to next dose level depend on good safety and tolerability on the previous dose level.
Masking
Single blind
Who is masked
Participant
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03278158
Sponsor's protocol ID
PP-CT01
Status last verified
Mar 2019
First submitted
28 Aug 2017
Last updated
22 Mar 2019
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, 1 mg/tablet, XEN-D0501, 2 mg/tablet and XEN-D0501, 4 mg/tablet in people with Diabetes Mellitus, Type 2, run by Pila Pharma at 1 site in Denmark.

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 6 inclusion and 20 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 22 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. 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?

Safety and tolerability of single ascending oral doses of XEN-D0501, (1, 2, 4 and 8 mg) versus placebo in type 2 diabetic patients in treatment with metformin (Incidence of adverse events in type 2 diabetic patients) (time frame: 1-3 weeks). 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 NCT03278158.

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 22 Mar 2019.

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