EUCTR2004-002701-68-DE进行中（未招募）不适用
A randomised, double-blind, placebo-controlled, multiple dose, time-lagged parallel groups trial, investigating the pharmacodynamics, the safety and tolerability and the pharmacokinetics of PSN9301 in type 2 diabetes patients - Not available
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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. Patients must give their signed 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 patient.
- •2. Patients diagnosed with type 2 diabetes according to WHO criteria.
- •3. Diabetes treatment: Diet treatment only for at least 2 weeks prior to screening, or ongoing treatment with oral antidiabetics, which must be withdrawn for a minimum of 2 weeks before dosing.
- •4. Males aged 30 <= age <= 74 years, or females aged 30 <= age <= 74 years if hysterectomised and therefore of no childbearing potential, or females aged 55 <= age <= 74 years of no childbearing potential as defined by amenorrhoea at least for the 12 months prior to inclusion.
- •5. Body mass index (BMI) between 22 and 35 kg/m2 inclusive.
- •6. 7.5 <= HbA1C <= 10.0%7.Plasma C-peptide within the normal reference range
- •8. Fasting blood glucose (FBG) 7.2 mmol/L <= FBG <= 12.0 mmol/L measured in plasma
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Pharmacological treatment with any of the following: Systemic steroids (within the last month), beta-blockers, and hormones (within the last month, hormone replacement therapy by female patients excluded).
- •2. Any medication that the Investigator expects could interfere with blood glucose levels.
- •3. Diabetic side complications
- •4. History of severe pancreatitis interfering with blood glucose levels (as evaluated by the Investigator).
- •5. History of, or current impaired hepatic function, ALAT or alkaline phosphatase >= 2 times upper normal level, and clinically increased liver size.
- •6. Creatinine clearance (calculated according to the Cockcroft-Gault formula), that in the opinion of the investigaor does indicate renal impairment: Creatinine clearance (mL×min-1) = (140 – age) × body weight (kg) (× 0.85 for females) / 72 × serum creatinine (mg/dL)
- •7. Hypertension (whether treated or not): systolic blood pressure > 160 mmHg blood pressure and/or >= 99 mmHg for diastolic blood pressure in the supine position.
- •8. History of, or current cardiac problems, as angina pectoris, myocardial infarction, or symptoms of ischemic heart disease.
- •9. Supine heart rate higher than 90 beats/min at each of 2 consecutive evaluations.
- •10. Clinically significant abnormal 12-lead ECG (as evaluated by the Investigator).
- •11. Positive urine pregnancy test (for female patients only).
- •12. Any disease or condition which the Investigator feels will interfere with the trial.
- •13. Patients who are known to have serum hepatitis or who are carriers of the Hepatitis B surface antigen (HBsAg) or Hepatitis C antibodies, or have a positive result to the test for HIV antibodies.
- •14. Patients with acute gastrointestinal symptoms at the time of entering the trial (e.g. nausea, vomiting, diarrhoea, or heartburn).
- •15. Any clinically significant abnormal laboratory test results at screening.
- •16. Patients who have received an investigational drug (new chemical entity or licensed product) in the month preceding the start of dosing, except antidiabetic medication.
- •17. Patients who have a significant history of alcoholism or drug/chemical abuse, or who have a positive result in the urine drug/alcohol screen, or who consume more than 21 units of alcohol per week (one unit of alcohol equals about 250 mL of beer or lager, one glass of wine, or 20 mL spirits).
- •18. Patients with a significant use of caffeine containing beverages (greater than 8 cups per day).
- •19. Patients who smoke more than 10 cigarettes, or the equivalent, per day and is unable to refrain from smoking during 3 days prior to the first dosing day and during the confinement period.
- •20. Patients with mental incapacity or language barriers which preclude adequate understanding or co-operation, who are unwilling to participate in the study, or who in the opinion of their general practitioner or the Investigator should not participate in the study.
- •21. Patients who have taken part in strenuous exercise within 4 days prior to dosing in this trial. Whether strenuous exercise has been undertaken will be evaluated by the Investigator, and strenuous exercise is not allowed during the trial.
- •22. Fasting blood glucose > 15 mmol/L more than 3 times during a 48-hour period during the period from screening to the run-in phase as measured in plasma.
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