EUCTR2009-011271-78-AT进行中（未招募）不适用
A trial comparing efficacy and safety of NN5401 with insulin glargine in insulin naive subjects with type 2 diabetes
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 752
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 defined as any procedure that would not have been performed during standard management of the subject)
- •2. Male or female = 18 years of age
- •3. Type 2 diabetes mellitus (diagnosed clinically) for = 6 months
- •4. HbA1c 7.5-11.0% (both inclusive) by central laboratory analysis
- •5. BMI = 40.0 kg/m2
- •6. Insulin naive subject (Allowed are: Previous short term insulin treatment up to 14 days; Treatment during hospitalisation or during gestational diabetes is allowed for periods longer than 14 days)
- •7. Ongoing treatment with: Metformin and at least one other OAD for at least 3 months prior to randomisation with the minimum doses stated:
- •- Metformin:(including fixed combination products) 1500 mg or maximum tolerated dose (at least 1000 mg daily)
- •- Insulin secretagogue (sulfonylurea or glinide): Minimum half of the daily maximal dose according to approved labelling
- •- DPP-4 inhibitor: Minimum 100 mg daily or according to approved labelling
- •- Acarbose: minimum half of the daily maximal dose or maximum tolerated dose
- •8. Ability and willingness to adhere to the protocol including performance of SMPG profiles according to the protocol
- •9. Subject is likely to comply with the Investigator’s instruction
- •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. Anticipated change in concomitant medication known to interfere with glucose metabolism, such as systemic corticosteroids, beta-blockers, MAO inhibitors
- •2. Use within the last 3 months prior to Visit 1 of GLP-1 receptor agonists and/or
- •thiazolidinediones (TZDs)
- •3. Anticipated significant lifestyle change during the trial, e.g. shift work (including permanent night/evening shift workers), as well as highly variable eating habits
- •4. Cardiovascular disease, within the last 6 months prior to visit 1, defined as: stroke; decompensated heart failure New York Heart Association (NYHA)1 class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty.
- •5. Uncontrolled treated/untreated severe hypertension (systolic blood pressure =180 mm Hg and/or diastolic blood pressure = 100 mmHg)
- •6. Impaired liver function, defined as ALAT = 2.5 times upper limit of normal (one retest analysed at the central laboratory within a week of receipt or the result is permitted with the result of the last sample being conclusive)
- •7. Impaired renal function defined as serum-creatinine = 125 µmolor = 1.4 mg/dL for males and = 110 µmol/L or = 1.3 mg/dL for females or glomerular filtration rate below 60 mL/min, calculated by the Cockroft & Gault formula and according to local practise for metformin use (one retest analysed at the central laboratory within a week is permitted with the result of the last sample being conclusive)
- •8. Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during last 12 months) or hypoglycaemic unawareness as judged by the Investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months
- •9. Proliferative retinopathy or maculopathy requiring treatment according to the Investigator
- •10. Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
- •11. Cancer and medical history (except basal cell skin cancer or squamous cell skin cancer)
- •12. Any clinically significant disease or disorder, except for conditions associated with type 2 diabetes, which in the Investigator’s opinion could interfere with the results of the trial
- •13. Mental incapacity, psychiatric disorder, unwillingness or language barriers precluding adequate understanding or co-operation, including subjects not able to read or write
- •14. Previous participation in this trial. Participation is defined as randomised. Re-screening of screening failures is allowed only once within the limits of the recruitment period
- •15. Known or suspected allergy to any of the trial products or related products
- •16. Receipt of any investigational drug within one month prior Visit 1
- •17. Donation of blood or participation in other trials within one month prior to Visit 1
- •18. Known or suspected abuse of alcohol, narcotics or illicit drugs
研究者
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