Establishing Cardiovascular Biomarkers to Define Preferred Lantus® Use.
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Fasting Intact Proinsulin
研究概览
简要总结
The aim of this study is to observe changes in cardiovascular biomarkers during treatment with Lantus in patients with Type 2 Diabetes mellitus.
详细描述
- Phase IV
- Indication: Diabetes mellitus Type 2
- Primary objective:
To compare fasting intact proinsulin secretion at the beginning and after a 24 week treatment period.
- Secondary objectives: To evaluate changes in the parameters
- insulin,
- glucose,
- intact proinsulin (after a glucose challenge),
- hsCRP,
- adiponectin,
- MMP-9,
- HbA1c,
- weight
after 24 weeks of treatment.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Give written informed consent.
- •Patient consents that his/her family physician/diabetologist will be informed of trial participation
- •Type-2 diabetes mellitus ≥ 1 year of diagnosis (male and female)
- •Experienced in self blood glucose measurement for ≥ 3 months.
- •HbA1c ≤ 9% and >6,5%
- •BMI > 30 kg/m²
- •Age ≥ 18 years
- •Waist circumference > 88 cm (female) and > 102 cm (male)
- •NPH insulin treatment plus 1 or 2 OAD (except TZD)
排除标准
- •History of drug or alcohol abuse within the last five years prior to screening
- •Anamnestic history of hypersensitivity to the study drugs (or any component of the study drug) or to drugs with similar chemical structures
- •History of severe or multiple allergies
- •Treatment with any other investigational drug within 3 months prior to screening
- •Progressive fatal disease
- •History of significant cardiovascular, respiratory, gastrointestinal, hepatic (ALAT and/or ASAT > 3 times the normal reference range), renal (creatinine > 1.3 mg/dl in women and >1.6 mg/dl in men), neurological, psychiatric and/or hematological disease as judged by the investigator
- •Pregnant or lactating women
- •Sexually active women of childbearing potential not consistently and correctly practicing birth control by implants, injectables, combined oral contraceptives, hormonal intrauterine devices (IUDs), sexual abstinence or vasectomized partner
- •Treatment with GLP1-analog or Thiazolidinediones (TZD)
- •hsCRP > 10 mg/l (by rapid test at screening visit).
- •Lack of compliance or other similar reason that, according to investigator, precludes satisfactory participation in the study
- •Type 1 Diabetes mellitus
- •Patients already treated with intensified conventional insulin therapy.
研究组 & 干预措施
NPH insulin + insulin glulisine
Patients will be randomized to be treated with NPH insulin + Insulin Glulisine for 24 weeks.
干预措施: nph insulin (Drug)
NPH insulin + insulin glulisine
Patients will be randomized to be treated with NPH insulin + Insulin Glulisine for 24 weeks.
干预措施: Insulin glulisine (Drug)
NPH insulin + human insulin
Patients will be randomized to be treated with NPH insulin + human insulin for 24 weeks.
干预措施: human insulin (Drug)
Insulin glargine + insulin glulisine
Patients will be randomized to be treated with insulin glargine + insulin glulisine for 24 weeks.
干预措施: Insulin Glargine (Drug)
Insulin glargine + insulin glulisine
Patients will be randomized to be treated with insulin glargine + insulin glulisine for 24 weeks.
干预措施: Insulin glulisine (Drug)
Insulin Glargine + Human insulin
Patients will be randomized to be treated with insulin glargine + human insulin for 24 weeks.
干预措施: human insulin (Drug)
Insulin Glargine + Human insulin
Patients will be randomized to be treated with insulin glargine + human insulin for 24 weeks.
干预措施: Insulin Glargine (Drug)
结局指标
主要结局
Fasting Intact Proinsulin
时间窗: Change from baseline at 24 weeks
The difference of fasting intact proinsulin after 24 weeks of treatment compared to baseline.
次要结局
- Weight(After 12 weeks of treatment compared to baseline and to 24 weeks of treatment.)
- hsCRP(After 12 weeks of treatment compared to baseline and to 24 weeks of treatment.)
- Adiponectin(After 12 weeks of treatment compared to baseline and to 24 weeks of treatment.)
- MMP-9(Baseline and after 24 weeks of treatment.)
- OGTT parameters (insulin, intact proinsulin, glucose at time point 0, 60 and 120 minutes after 24 weeks(Baseline and after 24 weeks of treatment.)
- HOMA-IR score(Baseline and after 24 weeks of treatment.)
- HbA1c(After 12 weeks of treatment compared to baseline and to 24 weeks of treatment.)
- Fasting intact Proinsulin(After 12 weeks of treatment compared to baseline and to 24 weeks of treatment.)
- Glucose(After 12 weeks of treatment compared to baseline and to 24 weeks of treatment.)
- Responder rate(After 24 weeks of treatment compared to baseline.)
- Hypoglycemic events.(Baseline up to 24 weeks.)