Is "Beta Cell Rest" by Insulin Treatment Beneficial Compared to State-of-the Art Enhancers of Insulin Secretion in Preserving Beta Cell Function in Subjects With Latent Autoimmune Diabetes of the Adult (LADA)?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- insulin secretion
研究概览
简要总结
The purpose of the study is to clarify whether patients classified as Latent autoimmune diabetes of the adult (LADA) benefit from early treatment with insulin added to per oral treatment and lifestyle measures.
详细描述
Latent autoimmune diabetes of the adult (LADA) is usually defined as a form of diabetes where the onset of diabetes takes place approximately after 30 years of age, where there is presence of beta-cell directed antibodies (mostly anti-GAD) and where there is no clinical need for insulin treatment during the first 6 months after the diagnosis of diabetes.
The aetiology and treatment of LADA patients is much less elucidated than is the case for type 1 diabetes (DM1) and type 2 diabetes (DM2). LADA constitutes about 10 % of the total diabetic population in many countries. LADA is therefore more common than insulin-requiring DM1.
LADA patients lose beta-cell function faster than patients with DM2. Residual beta-cell function in DM1 is coupled to better metabolic control with lesser degree of hyperglycemia, lesser frequency of hypoglycaemic events and lesser diabetic complications.
To retain beta-cell function in LADA patients is thus highly desirable.
There are several strategies to retain beta cell function. One therapeutic strategy is to induce some degree of "beta cell rest" by treatment with exogenous insulin. Several observations indicate that such a strategy can have beneficial effects.
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
- None
入排标准
- 年龄范围
- 30 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetes diagnosed during 0-3 years before entering the study.
- •Age > or equal to 30 years < or equal to 75 years
- •anti-GAD positivity
- •fasting C-peptide > or equal to 0,3 ng/ml
- •no need for insulin treatment by clinical judgement for at least 3 months following the diagnosis of diabetes.
- •HbA1c > 15 % above the upper limit of normal
排除标准
- •Renal insufficiency (plasma creatinine > 150 mol/L)
- •Severe retinopathy (proliferative or pre-proliferative)
- •Severe cardiac disease (NYHA III-IV)
- •Chronic severe illness judged by the investigator
- •Females of reproductive age who wish to become pregnant during the study
研究组 & 干预措施
Metformin + NPH Insulin
Patients are treated with metformin during the run-in period (3 months) and also after randomization. By randomization insulin treatment will be added in the form of injections of NPH insulin in the evenings.
干预措施: metformin+ NPH insulin (Drug)
Metformin + sitagliptin +/-repaglinid
Patients are treated with metformin during the run-in period (3 months) and also after randomization. By randomization sitagliptin tablets will be added.If HbA1c after 6 months of treatment is > 10 % above the upper limit of normal,then treatment with repaglinide tablets tree times daily at mealtimes will be added.
干预措施: metformin + sitagliptin +/- repaglinide (Drug)
结局指标
主要结局
insulin secretion
时间窗: 2 years
insulin secretion measured by fasting and glucagon-stimulated C-peptide
次要结局
- glycemic control(2 years)
