EUCTR2010-023182-22-DE进行中（未招募）不适用
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
Prosidion Ltd0 个研究点开始时间: 2010年11月26日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
- •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
排除标准
- •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 >
- •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
- •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
- •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
研究者
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