EUCTR2008-005776-27-ES进行中（未招募）1 期
A 52-week randomised, controlled, open label, multicentre, multinational treat-to-target trial comparing the efficacy and safety of SIBA and insulin glargine, both injected once daily in combination with oral anti-diabetic drugs (OAD), in subjects with type 2 diabetes mellitus currently treated with OAD(s) and qualifying for more intensified treatmentEnsayo de 52 semanas de duración, aleatorizado, controlado, abierto, multicéntrico, multinacional, con ajuste de dosis para comparar la eficacia y la seguridad de SIBA e insulina glargina, una vez al día en combinación con antidiabéticos orales (ADO(s)), en pacientes con Diabetes Mellitus tipo 2 tratados actualmente con ADO(s) y aptos para terapia más intensiva
相关药物
试验速览
- 阶段
- 1 期
- 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. 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. Insulin naïve subjects (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).
- •5. Current treatment: metformin monotherapy or metformin in any combination with an insulin secretagogue (sulfonylurea or glinide), DPP-IV inhibitor, a-glucosidase-inhibitors (acarbose) with unchanged dosing for at least 3 months prior to visit 1 with the minimum doses stated:
- •- Metformin: alone or in combination (including fixed combination) 1500 mg daily, or
- •maximum tolerated dose (at least 1000 mg daily)
- •- Insulin secretagogue (sulfonylurea or glinide): Minimum half of the daily maximal dose according to local labelling
- •- DPP-IV inhibitor: Minimum 100 mg daily or according to local labelling.
- •- a-glucosidase-inhibitors (Acarbose): Minimum half of the daily maximal dose or maximum tolerated dose.
- •6. HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis.
- •7. BMI = 40.0 kg/m2.
- •8. Ability and willingness to adhere to the protocol including performance of self measured plasma glucose (SMPG) profiles according to the protocol.
- •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. Use within the last 3 months prior to Visit 1 of: Thiazoledinediones (TZDs), exenatide or liraglutide.
- •2. Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, MAO inhibitors.
- •3. Off-label use of any concomitant medication, including OADs to be continued in the trial.
- •4. Cardiovascular disease, within the last 6 months prior to visit 1, defined as: stroke; decompensated heart failure New York Heart Association (NYHA)25 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 millimetre (mm) mercury (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 from receipt of the result is permitted with the result of the last sample being conclusive).
- •7. Impaired renal function defined as serum-creatinine = 125 µmol/l (= 1.4 mg/dl) for males and = 110 µmol/L (= 1.3 mg/dl) for females or according to local label for metformin [For France: glomerular filtration rate below 60 ml/min, calculated by the Cockroft & Gault formula]; one retest within a week from receipt of the result 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, or the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements [for Germany: implants, injectables, combined oral contraceptives, hormonal IUD, sexual abstinence or vasectomised partner].
- •11. Cancer and medical history of cancer (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 mellitus, 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 to 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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