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A Single-dose Trial to Investigate the Safety and Tolerability of XEN-D0501 in 24 Patients With Diabetes Mellitus Type 2

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ClinicalTrials.gov Identifier: NCT03278158
Recruitment Status : Recruiting
First Posted : September 11, 2017
Last Update Posted : October 26, 2018
Sponsor:
Information provided by (Responsible Party):
Pila Pharma

Brief 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 24 subjects with diabetes mellitus type 2 where life style changes and treatment with metformin has failed to effectively reduce blood glucose concentrations.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Placebo Drug: XEN-D0501, 1 mg/tablet Drug: XEN-D0501, 2 mg/tablet Drug: XEN-D0501, 4 mg/tablet Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 and 4 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 (Participant)
Masking Description: The type of treatment is blinded for the subjects.
Primary Purpose: Treatment
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 24 Patients With Diabetes Mellitus Type 2
Actual Study Start Date : September 18, 2017
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Subjects in the placebo arm will receive a single oral tablet containing no active drug.
Drug: Placebo
Subjects in the placebo arm will receive a single oral tablet containing no active drug.

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

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

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




Primary Outcome Measures :
  1. Safety and tolerability of single ascending oral doses of XEN-D0501, (1, 2 and 4 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 ]
    Incidence of adverse events in type 2 diabetic patients



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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 metformin, but no other anti-diabetic drugs
  4. In treatment with an ACE-inhibitor but no other anti-hypertensive drugs
  5. HbA1C (glycosylated haemoglobin A1C) 6.5-10 %
  6. Age between 30 and 70 years (both inclusive).

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 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).
  3. A subject who is in pharmacological treatment of hypertension if the current treatment includes other than an ACE-inhibitor
  4. A subject who has a clinically significant abnormal ECG at screening, as judged by the investigator.
  5. A subject who has participated in any other trials involving investigational products within the 3 months preceding the start of dosing.
  6. 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.
  7. 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.
  8. 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.
  9. 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.
  10. Surgery or trauma with significant blood loss within the last 2 months prior to dosing.
  11. 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.
  12. 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.
  13. A subject with a clinically significant abnormal haematology or biochemistry tests at screening visit, as judged by the Investigator considering the underlying disease.
  14. Current treatment with drugs known to interfere with glucose metabolism such as systemic corticoids and monoamine oxidase inhibitors (MAO) inhibitors.
  15. A subject who has proliferative retinopathy or maculopathy, and/or severe neuropathy, in particular autonomic neuropathy, as judged by the Investigator.
  16. 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.
  17. Previous participation (randomisation) in this trial.
  18. Any condition that would interfere with trial participation or evaluation of results, as judged by the investigator and/or sponsor
  19. Recurrent major hypoglycaemia or hypoglycaemic unawareness, as judged by the Investigator.
  20. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03278158


Contacts
Contact: Dorte X Gram, PhD +46 (0)73 903 69 69 dxg@pilapharma.com

Locations
Denmark
Odense University Hospital Recruiting
Odense, Denmark, 5000
Contact: Henning Beck-Nielsen, Dr       henning.beck-nielsen@rsyd.dk   
Sponsors and Collaborators
Pila Pharma
Investigators
Principal Investigator: Henning Beck-Nielsen, Dr. Odense University Hospital

Responsible Party: Pila Pharma
ClinicalTrials.gov Identifier: NCT03278158     History of Changes
Other Study ID Numbers: PP-CT01
First Posted: September 11, 2017    Key Record Dates
Last Update Posted: October 26, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Pila Pharma:
safety
tolerability

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases