ISRCTN09079822已完成不适用
INITIATE (INITiate Insulin by Aggressive Titration and Education): a randomised study to compare initiation of insulin combination therapy in type two diabetic patients individually and in groups
sanofi-aventis Oy (Finland)0 个研究点目标入组 120 人开始时间: 2006年11月14日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Male or female patients aged greater or equal to 18 years of age with type two diabetes
- •2. Treated with a stable dose (any dose) of sulfonylurea and metformin (1.5 grams or more) or either drug alone for at least six months
- •3. Body Mass Index (BMI) less than 45 kg/m^2
- •4. HbA1c between 7.0 and 12%
- •5. Willingness and ability to inject insulin and perform self-monitoring of blood glucose and to share some health information (glycemic control and body weight) with other members of the group
排除标准
- •1. Insulin therapy during the preceding 12 months
- •2. Impaired renal function, as shown by (but not limited to) serum creatinine more than 177 µmol/L (more than 2.0 mg/dL) measured at visit one or current renal dialysis
- •3. Gross proteinuria (dU-prot more than 3 g) at screening
- •4. Known acute or chronic metabolic acidosis, including diabetic ketoacidosis
- •5. Clinical evidence of active liver disease, or serum Alanine Aminotransferase (ALT) more than 2.5 times the upper limit of the normal range
- •6. History of hypoglycemia unawareness
- •7. Repeated (more than one) severe hypoglycemia with unconsciousness within the last year
- •8. Diabetic retinopathy with surgical treatment (laser photocoagulation or vitrectomy) during the preceding three months of study entry, or requiring treatment within three months after the study entry
- •9. Pregnancy or lactation
- •10. Failure to use adequate contraception (women of current reproductive potential only), e.g. use of systemic hormones (oral contraceptives or an implant), an intrauterine device, or a barrier method (diaphragm with intravaginal spermicide, cervical cap, male or female condom)
- •11. Known hypersensitivity to insulin glargine, or any of the excipients
- •12. Malignancy (except for basal cell skin cancer) within the last five years
- •13. Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol (e.g. non-cardioselective Beta-blockers, systemic corticosteroids, thiazolidinediones) months
- •14. Known adrenal insufficiency
- •15. Known haemoglobinopathy or moderate to severe anemia (i.e. hemoglobin concentration less than 110 g/dl)
- •16. Psychiatric condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
- •17. History of substance or alcohol abuse within the last two years, or current substance abuse
- •18. Inability to comply with study procedures
- •19. Any clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult
- •20. Known positive test result for Glutamic Acid Decarboxylase (GAD), or islet cell antibodies
- •21. Type one Diabetes Mellitus, as defined by the World Health Organisation (WHO)
- •22. Use of an investigational drug during the last six months before study entry
- •23. Inability to stop current treatment with thiazolidinedione
研究者
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