EUCTR2007-005317-19-FR进行中（未招募）1 期
The effect of insulin detemir in combination with liraglutide and metformin compared to liraglutide and metformin in subjects with type 2 diabetes.A 26-week, randomised, open-label, parallel-group, multicentre, multinational trial with a 26-week extension
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 940
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. Informed consent obtained before any trial-related activities (trial-related activities are any procedure that would not have been performed during normal management of the subject)
- •2. Subjects diagnosed with type 2 diabetes, insulin naïve and treated with metformin as monotherapy for = 3 months prior to screening, at a stable dose of = 1500 mg/day or metformin (= 1500 mg/day) and a sulfonylurea (less than or equal to ½ of the maximum approved dose according to local label), both at a stable dose for = 3 months prior to screening. Previous short-term insulin treatment in connection with intercurrent illness is allowed, at the discretion of the Investigator.
- •3. HbA1c 7.0-10.0% (both inclusive) for subjects on metformin monotherapy
- •HbA1c 7.0-8.5% (both inclusive) for subjects on metformin with a sulfonylurea
- •4. Age 18-80 years, both inclusive (or as allowed according to local guidelines)
- •5. Able and willing to perform self-monitoring of plasma glucose according to the protocol, to keep a diabetes diary and willing to use pen-injector device and FlexPen® device if necessary
- •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. Previous treatment with insulin (except for short-term treatment in connection with intercurrent illness at the discretion of the Investigator)
- •2. Treatment with glucose-lowering agent(s) other than stated in the inclusion criteria in a period of 3 months prior to screening
- •3. Impaired liver function, defined as alanine aminotransferase (ALAT) = 2.5 times upper normal limit (one retest analysed at the central laboratory within a week is permitted with the result of the last sample being the conclusive)
- •4. Impaired renal function defined as serum-creatinine = 133 µmol/L (= 1.5 mg/dL) for males and = 115 µmol/L (= 1.4 mg/dL) for females, or as allowed according to local contraindications for metformin or sulfonylurea use (one retest analysed at the central laboratory within a week permitted with the result of the last sample being the conclusive)
- •5. History of chronic pancreatitis or idiopathic acute pancreatitis
- •6. Known history of unstable angina, acute coronary event, other significant cardiac event (including history of arrhythmias or conduction delays on ECG), or cerebral stroke within the past 6 months.
- •7. Heart failure NYHA class IV (see appendix D)
- •8. Known proliferative retinopathy or maculopathy requiring acute treatment as judged by the Investigator
- •9. Uncontrolled treated or untreated hypertension (systolic blood pressure = 180 mmHg and/or diastolic blood pressure = 110 mmHg)
- •10. Cancer (except basal cell skin cancer or squamous cell skin cancer) or any clinically significant disorder, except for conditions associated with type 2 diabetes history which in the Investigator’s opinion could interfere with the results of the trial
- •11. Recurrent major hypoglycaemia or hypoglycaemic unawareness as judged by the Investigator
- •12. Known or suspected allergy to trial product(s) or related products
- •13. Use of any drug (except for those stated in the inclusion criteria), which in the Investigator’s opinion could interfere with the glucose level (eg systemic corticosteroids)
- •14. Receipt of any other investigational drug within 3 months prior to screening into this trial
- •15. Any contraindications to metformin or insulin detemir according to the local label
- •16. Surgery scheduled for the trial duration period (excluding minor surgical procedures performed in local anaesthesia, as judged by the Investigator)
- •17. Previous participation in the run-in period of this trial.
- •18. Known or suspected abuse of alcohol or narcotics
- •19. Females of child bearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice) UK: Adequate contraceptive measures are defined as established use of oral, injected or implanted hormonal methods of contraception, sterilisation, intrauterine device or intrauterine system, or consistent use of barrier methods. France: Adequate contraceptive measures are defined as oral hormonal method of contraception or intrauterine device. Germany: Adequate contraceptive measures are implants, injectables, combined oral contraceptives, hormonal IUD, sexual abstinence or vasectomised partner.
- •20. Mental incapacity, unwillingness or language barrier precluding adequate understanding or cooperation
研究者
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