An investigation to investigate whether a single dose of XEN-D0501 is tolerable by type 2 diabetic patients prior to multiple dose trials (to investigate if the compound can effectively regulate diabetes)
- Conditions
- Type 2 diabetesTherapeutic area: Body processes [G] - Metabolic Phenomena [G03]
- Registration Number
- EUCTR2016-003843-12-DK
- Lead Sponsor
- PILA PHARMA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 26
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) 7-9 %
6. Age between 30 and 70 years (both inclusive).
7. Body mass index (BMI) 27 to 35 kg/m2
8. Fasting C-peptide > 600 pmol/l
9. Abdominal adiposity, defined waist circumference > 102 cm for male and > 88 cm for
female subjects
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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 antihypertensives),
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, 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 usin
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the 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.;Secondary Objective: Besides it is the purpose of this trial to identify the optimal dose for later clinical trials to study the efficacy of XEN-D0501 in patients with type 2 diabetes with the aim of developing a novel type of type 2 diabetes.;Primary end point(s): Safety and tolerability of XEN-D0501 in patients with type 2 diabetes;Timepoint(s) of evaluation of this end point: Evaluation for 8 h after single oral dose
- Secondary Outcome Measures
Name Time Method Secondary end point(s): • Adverse events (AEs) / Severe adverse events (SAEs)<br>• Hyperthermia events<br>• Hypoglycemic events<br>• Physical examinations<br>• Electrocardiogram (ECG)<br>• Vital signs<br>• Laboratory safety variables<br>;Timepoint(s) of evaluation of this end point: For 8 h after single oral dose