A Phase 2, Double-Blind, Placebo-Controlled, Randomised, Single Dose, Crossover Study to Investigate the Glucose Lowering of PSN821 in Patients with Type 2 Diabetes (T2DM) after an Ensure Plus challenge
- Conditions
- Type 2 Diabetes mellitusMedDRA version: 12.1Level: LLTClassification code 10067585Term: Type 2 diabetes mellitus
- Registration Number
- EUCTR2010-023182-22-DE
- Lead Sponsor
- Prosidion Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1. Signed and dated written informed consent obtained before any study-related activities
2. Male and female patients with a diagnosis of type 2 diabetes mellitus according to ADA
criteria at least 4 months prior to screening
3. Medical history without major pathology (with the exception of type 2 diabetes)
4. On a stable regimen of metformin monotherapy (minimum of 850 mg/day) prior to
screening (medication type and dose unchanged for the last 3 months)
5. Aged between 18 and 65 years of age, both inclusive
6. Body mass index (BMI) between 25 and 40kg/m2, both inclusive
7. HbA1c between 6.8 and 9.5 %, both inclusive
8. Fasting plasma glucose (FPG) between 126 and 270 mg/dL (7-15 mmol/L), both inclusive
9. A female patient is eligible to participate if she is of:
Non-childbearing potential defined as pre-menopausal females with a documented tubal
ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous
amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating
hormone (FSH) > 40 MlU/ml and estradiol < 40 pg/mL (<140 pmol/L) is confirmatory].
Females on stable hormone replacement therapy are allowed to participate in the study at
the discretion of the Investigator. All female patients must have a negative pregnancy test
results at screening.
10. A male patient who is sexually active and not surgically sterilised, must agree to use
adequate contraceptive methods as described in Section 4.3.2.1 from the time of first
study drug administration until 90 days after last dosing.
11. Ability and willingness to abstain from grapefruit juice (and all grapefruit containing
products) throughout the study and from alcohol, methylxanthine-containing beverages or
food (coffee, tea, Coke, chocolate, power drinks”), tobacco products and from engaging
in strenuous physical activity from 24 hours prior to each admission until discharge from
the unit
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Patients with type 1 diabetes, maturity onset diabetes of the young (MODY) or secondary
forms of diabetes such as due to pancreatitis
2. Current or previous treatment with insulin therapy
3. Treatment with any hypoglycaemic medication other than metformin within the three
months prior to screening
4. Patients with any severe medical or surgical history of conditions likely to confound study
assessments or study endpoints20. Participation in another clinical trial within the 3 months preceding screening or 5-halflives
5. Serious respiratory, serious and/or unstable coronary heart disease
6. History of arrhythmia
7. Marked diabetic complications
8. Clinically significant vital signs or 12-lead ECG findings including pre-treatment QTcF >
450msec
9. Clinically significant abnormal haematology, biochemistry, lipids, or urinalysis or
coagulation screening tests
10. Moderate or severe renal dysfunction
11. Clinical or laboratory evidence of hepatic dysfunction or disease
12. Uncontrolled high blood pressure (DBP > 95 mmHg and/or SBP > 160 mmHg)
13. History of any psychiatric condition that might impair the patient’s ability to understand
or to comply with the requirements of the study or to provide informed consent
14. History of relevant drug and/or food allergies or a history of severe anaphylactic reaction
15. Smoking more than 5 cigarettes/cigars/pipes daily
16. Currently active or history of alcohol abuse
17. Positive screen for drugs of abuse or alcohol test at screening
18. Use of concomitant medication which would confound study conduct
19. Use of drugs that have a known risk of causing Torsades de Pointes are prohibited within
14 days prior to randomisation.
20. Participation in another clinical trial within the 3 months preceding screening or 5-halflives
of drug studied, whichever is longer, prior to study medication administration
21. Participation in more than three other clinical trials in the ten months preceding screening
22. Malignancy within 5 years of study start, except for successfully treated local basal cell
carcinomas
23. Patients known to be positive for Hepatitis B surface antigen or Hepatitis C antibodies (or
diagnosed with active hepatitis according to local practice)
24. Positive result to the screening test for HIV-1 antibodies, HIV-2 antibodies or HIV-1
antigen according to locally used diagnostic testing
25. Patients in whom metformin is contraindicated according to the local SPC
26. Use of concomitant medication which would be likely to interact with metformin
(according to the Patient information leaflet)
27. Patient who has donated or lost more than 500 mL blood within 3 months prior to
screening
28. Significant illness within five days prior to the first administration of study medication
29. History of hypersensitivity to the study medication or any of the excipients or to medicinal
products with similar chemical structures
30. Veins unsuitable for repeat venipuncture
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method