NCT00974740终止1 期
DIATOR - Diabetes Intervention With Atorvastatin. A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Investigate the Effect of Atorvastatin on Residual Beta-cell Function and Glycemic Control in Patients With Newly Diagnosed Type 1 Diabetes Mellitus
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 63
- 试验地点
- 12
- 主要终点
- C-peptide after a liquid mixed meal stimulation
研究概览
简要总结
Clinical studies have shown that immunomodulators (like Anti-CD3 antibodies) have effects on beta-cell-preservation. The lipid-lowering agent atorvastatin is also a potent immunomodulator. In this study the effects of 80 mg atorvastatin per day on preservation of beta-cell function in recent onset type 1 diabetes were studied, as determined by stimulated C-peptide levels.
详细描述
The objectives of this study were as follows:
- To assess the effect of atorvastatin on pancreatic beta-cell function as measured by C-peptide after a liquid mixed meal stimulation in patients with newly diagnosed type 1 diabetes,
- To assess the effect on metabolic control as measured by HbA1c and insulin requirements,
- To assess safety and tolerability of atorvastatin in subjects with newly diagnosed type 1 diabetes,
- To assess the effect on risk factors of diabetic complications as indicated by changes in lipids and CRP, and
- To assess the effect on systemic immune abnormalities as measured by effects on beta-cell autoantibodies, blood cytokines and chemokines on protein and transcriptional level.
Study duration: 18 months
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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Insulin treated patients with a newly diagnosed type 1 diabetes mellitus as defined by the ADA criteria at least two weeks but not later than 3 months after start of insulin treatment
- •Age 18 to 39 years, inclusive
- •Male patient or female patient using adequate contraceptive methods
- •Tested positive for at least one of the three islet autoantibodies GAD65, IA2 or ICA
排除标准
- •History of a malignancy
- •Presence of a clinically significant hepatic or renal disease, as indicated, but not limited to a serum creatinine elevated more than ten percent above the upper limit of normal, elevation of AST or ALT more than 3 times the upper limit of normal
- •Any other acute or chronic condition that may affect the patient's response to treatment or might be associated with an increased risk for the patient to participate, as judged by the investigator
- •Current use of anti-inflammatory or immunomodulatory drugs, antihypertensive, lipid-lowering, or antidiabetic drugs other than insulin
- •Pregnant or nursing women or women intending to become pregnant
- •Known or suspected allergy to atorvastatin or any component of thr trial product
- •Known myopathy, myalgia or myositis with a serum-CPK above 3 times the upper limit of normal
- •Patients who had a severe blood loss (>= 400 mL, e.g. blood donation) within 2 months prior to visit 2
- •Any significant laboratory abnormality
- •A serum LDL-cholesterol above 150 mg/dL at time of screening
- •Unwillingness to comply with study procedures
研究组 & 干预措施
atorvastatin matching placebo
Placebo Comparator
atorvastatin matching placebo
干预措施: atorvastatin matching placebo (Drug)
atorvastatin
Experimental
40 mg atorvastatin for 4 weeks (run-in period), then 80 mg atorvastatin, total treatment period was 18 months
干预措施: Atorvastatin (Drug)
结局指标
主要结局
C-peptide after a liquid mixed meal stimulation
时间窗: at randomization, after 12 months, and after 18 months of treatment
次要结局
- HbA1c(at randomization, after 6, 12, and 18 months of treatment)
- serum lipids(at randomization, and after 3, 6, 12, and 18 months of treatment)
- insulin dose(at randomization, and after 3, 6, 12, and 18 months of treatment)
- adverse events(at randomization, and after 3, 6, 12, and 18 months of treatment)
- plasma CRP(at randomization, and after 3, 12, and 18 months of treatment)
研究者
研究点 (12)
Loading locations...
相似试验
已完成
不适用
Pediatric Atorvastatin in Diabetes Intervention Trial (PADIT)Type 2 Diabetes MellitusType 1 Diabetes MellitusNCT00130481University of Florida100
已完成
4 期
Systemic Immunomodulatory Effects and Pharmacogenetics of Atorvastatin in Early AtherosclerosisInflammationNCT00361283University of Florida108
已完成
3 期
Atorvastatin for HAART Suboptimal RespondersAcquired Immune Deficiency Syndrome VirusNCT01766076Makerere University30
已完成
2 期
Improving Diabetic Foot Ulcers With AtorvastatinFoot UlcerDiabetesNCT00134550Asker & Baerum Hospital13
已完成
不适用
Effect of Diabetes Mellitus on Cholesterol MetabolismType 2 Diabetes MellitusHypercholesterolemiaType 1 Diabetes MellitusNCT00879710Medical College of Wisconsin57