EUCTR2009-010913-59-DE进行中（未招募）不适用
Health Assessment, Patient treatment satisfaction and Quality-of-Life in insulin-naive type 2 diabetes Patients uncontrolled on OHA treatment initiating basal insulin therapy with either insulin glargine or NPH insulin added to therapies with oral hypoglycemic agents. A multicenter, prospective, crossover, open randomized clinical phase-IV trial. - HAPPY
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
- 332
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
- •Written Informed Consent must be obtained for all patients before commencement in the study at visit 1 (Appendix A: Informed Consent document). Subjects meeting all of the following inclusion criteria will be considered for enrollment into the study:
- •1.Patients with type 2 diabetes mellitus (no history of ketoacidosis) according to ADA criteria (24)
- •2.Treatment with one or maximum two oral antihyperglycemic agents on a stable dosage during at least at the last 4 weeks from the following substances/substance classes: metformin, sulfonylurea, DPP-IV inhibitors.
- •3.No pre-treatment with any insulin in the last 3 months before the study.
- •4.HbA1c value between = 7.0% and = 10.0%.
- •5.FBG = 120 mg/dl (6.7 mmol/l).
- •6.Men and women aged between 18-80 years inclusive.
- •7.Body mass index > 22 kg/m²and <40 kg/m².
- •8.Ability to read and understand German language.
- •9.Ability and willingness to follow a tight antidiabetic therapy and to perform blood glucose self monitoring on a regular basis.
- •10.Women of childbearing potential who will take adequate contraceptive protection such as systemic hormones (birth control pills, implant), intrauterine device (IUD), a barrier method (diaphragm with intravaginal spermicide, cervical cap, male or female condom), or whose partner is sterilized or who perform sexual abstinence.
- •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.Patients with type 1 diabetes mellitus.
- •2.Any history of ketoacidosis
- •3.Pregnancy (as determined by pregnancy serum test at visit 1).
- •4.Prior treatment with insulin within the last 3 months before the study
- •5.Treatment with more than two oral agents within the last 4 weeks or continuous treatment with thiazolidinediones or GLP-1 receptor agonists.
- •6.History of drug or alcohol abuse.
- •7.Diabetic retinoathy with surgical treatment (laser photocoagulation or vitrectomy) in the last 3 months prior to study entry or which may require surgical treatment within 3 months of study entry.
- •8.Following pancreatectomy.
- •9.Impaired hepatic function, as shown by, but not limited to, SGPT (ALAT) or SGOT (ASAT), above 2x the upper limit of normal measured at visit 1.
- •10.Impaired renal function, as shown by, but not limited to, serum creatinine > 177 µmol/l (> 2.0 mg/dl) measured at visit 1.
- •11.Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study.
- •12.Evidence of an uncooperative attitude, including poor compliance to any (antidiabetic) treatment.
- •13.Inability to attend the visits according to the study schedule.
- •14.Absence of adequate contraception
- •15.Current treatment because of a psychiatric disease.
- •16. Patients that are in a relationship of dependance with the investigator(s) and/or the sponsor.
- •17.Systemic corticoids > 7,5 mg prednisolon equivalent or = 7,5 mg prednisolon equivalent for less than 2 months.
- •18.Current participation in other clinical studies or participation in a clinical study during the last 3 months prior to participation in this study.
- •19.Patient underwent bariatric surgery for weight reduction (e.g. gastric banding)
- •20.Patient undertook major dietary changes for weight management during the last 3 months prior to participation in this study, resulting in weight reduction of at least 5kg
研究者
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