EUCTR2007-006640-22-SE进行中（未招募）不适用
Superiority of insulin glargine Lantus vs. NPH: Treat to Normoglycemia concept”.Effect of Insulin Glargine in Comparison to Insulin NPH in Insulin-naïve People with Type 2 Diabetes Mellitus Treated with at Least One OAD and Not Adequately Controlled. - LANCELOT
适应症
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
- 670
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
- •Inclusion criteria
- •Aged from 30 to 70 years inclusively
- •Insulin-naïve type 2 diabetes mellitus
- •Type 2 diabetes mellitus diagnosed for at least 1 year
- •Treated with at least one OAD (Metformin [daily dose of at least 1000mg], Sulfonylurea, glinides or alpha-glucosidase inhibitor) at stable dose for at least 3 months.
- •HbA1c > or = 7.0% and < or = 10,5%
- •BMI < 40 kg/m2
- •Ability and willingness to perform plasma glucose monitoring using the sponsor-provided glucose meter and patient diary at home
- •Informed consent obtained in writing at enrolment into the study
- •Willingness and ability to comply with the study 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
- •Treatment with GLP-1 agonists or with DPP-IV inhibitors in the 3 months prior to study entry
- •Treatment with TZD as monotherapy
- •Diabetes mellitus other than Type 2 (e.g. secondary to pancreatic disorders, drugs or chemical agents intake
- •Active proliferative retinopathy, as defined by a photocoagulation or vitrectomy occurrence in the 6 months prior to visit 1, or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgical treatment during the study (an optic fundus examination should have been performed within the 2 years prior to study entry)
- •Impaired renal function: serum creatinine = 1.5 mg/dL (= 133µmol/L) or = 1.4 mg/dL (= 124 µmol/L) in men and women, respectively
- •History of sensitivity to the study drugs or to drugs with a similar chemical structure
- •Impaired hepatic function (ALT and/or AST > 3 x upper limit of normal range)
- •Pregnant or lactating women; Women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraceptive method. Medically approved contraceptive method is defined as contraceptive pill, contraceptive patch, hormonal implant, injectible contraceptive and intrauterine device. Local approved method is defined as condom and cap with intravaginal spermicide. States that do not require contraception are tubal ligation, hysterectomy, oophorectomy, infertility and vasectomized partner. Women that have reach menopause are defined as no menstrual period for 12 consecutive months and no other biological or physiological cause can be identified.
- •Treatment with systemic corticosteroids within the 3 months prior to study entry or likelihood of requiring treatments during the study which are not permitted.
- •Treatment with an investigational product in the 30 days prior to visit 1
- •Alcohol or drug abuse in the last year
- •Presence of any condition (medical, psychological, social or geographical), current or anticipated that the Investigator feels would compromise the patient’s safety or limit the patient successful participation in the study (including night shift worker)
研究者
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