NCT00135083已完成3 期
One Versus Two Versus Three Daily Rapid-acting Insulin Injections of APIDRA (Insulin Glulisine) as add-on to Lantus® and Oral Sensitizer Basal Therapy in Type 2 Diabetes: a Multicenter, Randomized, Parallel, Open-label Clinical Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 347
- 主要终点
- To show non-inferiority between treatment groups (insulin glargine plus insulin glulisine administered once a day, twice a day, or 3 times a day) in the change in glycemic control as measured by hemoglobin A1C.
研究概览
简要总结
The purpose of this study is to show the non-inferiority of insulin glulisine administered with 1 meal versus 2 meals versus 3 daily meals, as measured by the change in hemoglobin A1c (HbA1c), from baseline to study week 24.
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 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects 18 to 79 years of age with a diagnosis of type 2 diabetes mellitus for at least 6 months
- •Current treatment with a stable dose of 2 oral antidiabetic agents. The oral agents must be in 2 or 3 of the following 3 different classes:
- •Sulfonylurea: dosage greater than or equal to, one-half the maximum recommended dosage (eg, glimepiride >/= 4 mg; glipizide, including gastrointestinal therapeutic system [GITS], >/= 10 mg; glyburide >/= 10 mg; Glynase® >/=3 mg). The dosage must have been stable for at least 3 months prior to screening.
- •Biguanide: metformin dosage ≥ 1000 mg daily, including Glucophage XR®. The dosage must have been stable for at least 3 months prior to screening.
- •Thiazolidinedione (TZD): pioglitazone >/= 15 mg or rosiglitazone >/= 24 mg. The subject must have been using the same thiazolidinedione for at least 6 months,and the dosage must have been stable for at least 3 months prior to screening.
- •HbA1c >/= 8.0%
- •Fasting C-peptide concentration > 0.27 nmol/L
- •Able and willing to perform self-monitoring of blood glucose (SMBG) up to 4 times a day
- •Able and willing to adhere to, and be compliant with, the study protocol
- •Able to read English or Spanish at the sixth-grade level in order to complete the subject reported outcomes component of the study
- •Signed informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
排除标准
- •Insulin use within the previous year
- •History of hypoglycemia unawareness
- •Acute or chronic, or history of, metabolic acidosis, including diabetic ketoacidosis
- •Impaired renal function as shown by, but not limited to, serum creatinine ≥ 3mg/dL. For subjects taking metformin, serum creatinine >/= 1.5 mg/dL for males, or >/= 1.4 mg/dL for females.
- •Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels greater than 2.5 times the upper limit of normal (ULN)
- •Clinically significant peripheral edema if subject is using a TZD
- •History of stroke, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, or angina pectoris, within the past 12 months
- •History of, or current, congestive heart failure (New York Heart Association [NYHA] III-IV) requiring pharmacologic treatment
- •Acute infection
- •Any malignancy within the past 5 years, with the exception of adequately treated basal or squamous cell carcinoma or adequately treated cervical carcinoma in situ
- •Current substance addiction or alcohol abuse or history of substance or alcohol abuse, within the past 2 years
- •Any clinically significant renal disease (other than proteinuria) or hepatic disease
- •Pregnant or lactating females
- •Dementia or mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
- •Impaired dexterity or vision rendering the subject unable to administer injections
- •Known hypersensitivity to insulin glargine or insulin glulisine or any of the components of Lantus or Apidra
- •Any disease or condition (including abuse of illicit drugs, prescription medications, or alcohol) that, in the opinion of the investigator or sponsor, may interfere with the completion of the study
- •Unlikely to comply with the protocol, eg, uncooperative attitude, inability to return for follow-up visits, or unlikely to complete the study
- •Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff, or relative thereof, directly involved in the conduct of the protocol
- •No subject will be allowed to enroll in this study more than once.
研究组 & 干预措施
1
Experimental
Once daily:
- Insulin glulisine Dosing: Supper, Lunch, Breakfast
- Monitoring Needed at: Bedtime,Pre-Supper, Pre-Lunch
干预措施: insulin glulisine (Drug)
2
Experimental
Twice daily:
- Insulin glulisine Dosing: Supper & Lunch, Lunch & Breakfast, Breakfast & Supper
- Monitoring Needed at: Bedtime & Pre-Supper, Pre-Supper & Pre-Lunch, Pre-Lunch & Bedtime
干预措施: insulin glulisine (Drug)
3
Experimental
Twice daily:
- Insulin glulisine Dosing: Supper, Lunch, Breakfast
- Monitoring Needed at: Bedtime, Pre-Supper, Pre-Lunch
干预措施: insulin glulisine (Drug)
结局指标
主要结局
To show non-inferiority between treatment groups (insulin glargine plus insulin glulisine administered once a day, twice a day, or 3 times a day) in the change in glycemic control as measured by hemoglobin A1C.
时间窗: From baseline to study week 24.
次要结局
未报告次要终点
研究者
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