Study of Metformin HCL in Patients With Type 2 Diabetes Intensively Treated With Insulin: a Treatment Strategy for Insulin Resistance in Type 2 Diabetes Mellitus: a Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- To investigate the quality of the metabolic control of diabetes and related variables (daily dose of insulin, body weight).
研究概览
简要总结
The HOME-trial is a prospective, randomized controlled trial. The purpose of this study is to investigate the effects of metformin HCL in patients with type 2 diabetes mellitus intensively treated with insulin on the quality of the metabolic control of diabetes, the daily dose of insulin, the lipid profile, the blood pressure, the incidence / progression of microvascular and macrovascular complications, and on the qualify of life (Diabetes Health Profile). Early results had been published in Diabetes Care, December 2002, pages 2133-2140.
详细描述
The HOME-trial is a prospective, randomized controlled trial. The purpose of this study is to investigate the effects of metformin HCL in patients with type 2 diabetes mellitus intensively treated with insulin on the quality of the metabolic control of diabetes, the daily dose of insulin, the lipid profile, the blood pressure, the incidence / progression of microvascular and macrovascular complications, and on the qualify of life (Diabetes Health Profile). Early results had been published in Diabetes Care, December 2002, pages 2133-2140.
Phase: Phase III
Study Type: Interventional
Overall Status: No longer recruiting (all patients have finished the study)
Study Start Date 02 January 1998
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both sexes (women after menopause, women of child-bearing age after sterilization or if practicing reliable contraception)
- •Type 2 DM requiring insulin therapy after failure of maximal oral antidiabetic treatment (glycosylated Hb > 7.5%) and need for exogenous insulin. (No concomitant use of oral antidiabetic agents)
- •Being ambulatory
- •Age: 30 to 80 years
- •Proven absence of Islet Antibodies, if QI < 28 kg/m2
- •Insulin therapy 4 times daily (21), or insulin therapy 2 times daily using insulin 'mixtures' (rapidly and slowly acting)
- •Standard dietary prescription by the dietician
- •Absence of keto-acidosis
- •Informed consent
排除标准
- •Congestive heart failure, NYHA-classes III or IV
- •Cardiac failure and/or myocardial infarction in the last four months before enrolment
- •Other severe organic / systemic disease
- •Metformin-induced lactic-acidosis
- •Intolerance to metformin hydrochloride
- •Renal disease or renal dysfunction
- •Hypoxic states
- •Severe hepatic dysfunction
- •Excessive alcohol intake, acute or chronic
- •Acute or chronic metabolic acidosis
结局指标
主要结局
To investigate the quality of the metabolic control of diabetes and related variables (daily dose of insulin, body weight).
次要结局
- To investigate the occurrence and progression of macro- and microvascular complications.
- To investigate the quality of life.
- To perform a socio-economic evaluation.