NCT00191464已完成4 期
Long-Term Effects of Insulin Plus Metformin Regimens on the Overall and Postprandial Glycemic Control of Patients With Type 2 Diabetes: A Comparison of Premeal Insulin Lispro Mixtures to Once-Daily Insulin Glargine
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 320
- 试验地点
- 8
- 主要终点
- HbA1C
研究概览
简要总结
The primary objective of this study is to show that a prandial insulin regimen, consisting of premeal insulin lispro "mid mixture" (or a combined regimen of insulin lispro "mid mixture" and insulin lispro "low mixture") plus metformin will result in significantly better overall glycemic control (lower HbA1c) at endpoint than once-daily insulin glargine plus metformin. Insulin lispro "mid mixture" consists of 50% insulin lispro and 50% NPL. Insulin lispro "low mixture" consists of 25% insulin lispro and 75% NPL.
In a substudy of approximately 60 patients, additional data will be collected on markers associated with risk of atherosclerosis or cardiovascular disease in the context of a controlled, outpatient, high-fat test meal.
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
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have type 2 diabetes (World Health Organization [WHO] classification
- •Have used one or more of the following oral anti-hyperglycemic medications-metformin or second-generation sulfonylurea (for example, glibenclamide, glyburide, glipizide, gliclazide, glimepiride) alone or in combination with one or two insulin injections per day for at least 3 months immediately prior to entering the study. Patients using more than 2 insulin injections per day or subcutaneous insulin infusion prior to the study will not be eligible to participate.
- •Have a hemoglobin A1c between 6.5% and 11%, inclusive, according to the central laboratory at Visit
- •Have clinically acceptable LDL-C, in the investigator's opinion, at Visit
- •As determined by the investigator, are capable and willing to learn how to use the insulin injection pens; comply with their prescribed diet, exercise, and medication regimen; perform self-monitoring of blood glucose; and use the patient diary as required for this protocol.
排除标准
- •Have hypersensitivity to metformin or a known allergy to metformin hydrochloride, insulin lispro MM, insulin lispro LM, or insulin glargine, or excipients contained in these products.
- •Have known metabolic or lactic acidosis.
- •Have a history of renal transplantation or are currently receiving renal dialysis or have serum creatinine greater than or equal to 135 micromol/L (1.5 mg/dL) for males and greater than or equal to 110 micromol/L (1.2 mg/dL) for females.
- •Have cardiac disease with functional status that is Class III or IV
- •Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or alanine transaminase (ALT) greater than three times the upper limit of the reference range as defined by the central laboratory.
结局指标
主要结局
HbA1C
次要结局
- Total cholesterol
- Oxidized LDL
- Fibrinogen
- Frequency and incidence of hypoglycemia
- Surrogate measure of vascular reactivity [substudy]
- Inflammatory markers [substudy]
- Production of advanced glycation end-products [substudy]
- Triglycerides
- Pilot two questionnaires for microvascular complications
- Retinyl ester measurements in various fractions [substudy]
- Apolipoproteins [substudy]
- High-density lipoprotein cholesterol
- General inflammation (hsCRP)
- Lipoproteins and apoproteins
- Generation of oxidative species [substudy]
- Blood glucose levels (based on self-monitoring)
- Insulin dose
- Safety
- General well-being
- Coagulopathy factors [substudy]
- Lipids in various fractions [substudy]
- Composition of triglyceride-rich lipoproteins [substudy]
- Compartmental modeling of postprandial lipemia [substudy]
- Weight
- Estimates of low-density lipoprotein cholesterol
- Nuclear magnetic resonance [NMR] analysis of lipids
研究者
研究点 (8)
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