Safety and Efficacy of Insulin Glargine Injection [rDNA Origin] Treatment in Place of the TZD or the Sulfonylurea or Metformin in Triple Agent Therapy for T2DM Adult Subjects With Unsatisfactory Control
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Sanofi
- 入组人数
- 390
- 试验地点
- 1
- 主要终点
- Change in Hemoglobin A1c (HbA1c) From Baseline to Week 12
研究概览
简要总结
The purpose of this study is to compare the change in hemoglobin A1c (HbA1c) from baseline to Week 12 between the 3 treatment arms.
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
- •Subjects meeting all of the following criteria will be considered for enrollment into the study:
- •18 to 79 years of age, inclusive
- •Diagnosis of type 2 diabetes mellitus
- •Continuous treatment with therapeutic dosages of a thiazolidinedione (rosiglitazone or pioglitazone), metformin, and a sulfonylurea daily prior to entering the study
- •Screening HbA1c ≥ 7.0%
- •Fasting C-peptide concentration ≥ 0.27 ng/ml
- •Negative glutamic acid decarboxylase (GAD) antibodies
- •Demonstrated ability and willingness to perform self-monitoring blood glucose (SMBG) using a plasma-referenced glucose meter and to maintain an electronic diary
- •Demonstrated ability and willingness to use an electronic diary to record SMBG results, insulin doses, and hypoglycemic events.
- •Signed, informed consent and Health Insurance Portability and Accountability Act (HIPAA) documentation
排除标准
- •Stroke, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, or angina pectoris, within the last 12 months
- •Cardiac status New York Heart Association (NYHA) III-IV
- •Impaired renal function as shown by, but not limited to, serum creatinine ≥ 1.5 mg/dL for males, or ≥ 1.4 mg/dL for females
- •Chronic use of insulin: (more than 3 weeks of continuous use) in the past 12 months
- •Acute infection
- •Clinically significant peripheral edema
- •Acute or chronic history of metabolic acidosis, including diabetic ketoacidosis
- •Clinical evidence of active liver disease, or serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 2.5 times the upper limit of the normal range
- •History of hypoglycemia unawareness
- •Pregnancy or lactation
- •Known hypersensitivity to insulin glargine or any of the components of Lantus®
- •Known hypersensitivity to insulin glulisine or any of the components of Apidra®
- •Any malignancy within the last 5 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or adequately treated cervical carcinoma in situ
- •Current addiction or current alcohol abuse, or history of substance or alcohol abuse within the last 2 years
- •Diagnosis of dementia
- •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
- •Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study. Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study
- •subject is currently taking or was treated with the following medications 3 months prior to screening: Byetta(exenatide), Starlix(nateglinide),Prandin (repaglinide), Januvia(sitagliptin), Janumet(metformin + sitagliptin)
- •Any disease or condition that in the opinion of the investigator and/or sponsor may interfere with the completion of the study
研究组 & 干预措施
Insulins + Metformin (MET) + Sulfonylurea (SU)
Arm 3: Insulin glargine administered subcutaneously once daily plus metformin and a sulfonylurea. Insulin glulisine will be added arms after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
干预措施: Insulin Glargine (Drug)
Insulins + Metformin (MET) + Sulfonylurea (SU)
Arm 3: Insulin glargine administered subcutaneously once daily plus metformin and a sulfonylurea. Insulin glulisine will be added arms after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
干预措施: Insulin Glulisine (Drug)
Insulins + Sulfonylurea (SU) + Thiazolidinedione (TZD)
Arm 1: Insulin glargine administered subcutaneously once daily plus a sulfonylurea and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
干预措施: Insulin Glargine (Drug)
Insulins + Sulfonylurea (SU) + Thiazolidinedione (TZD)
Arm 1: Insulin glargine administered subcutaneously once daily plus a sulfonylurea and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
干预措施: Insulin Glulisine (Drug)
Insulins + Metformin (MET) + Thiazolidinedione (TZD)
Arm 2: Insulin glargine administered subcutaneously once daily plus metformin and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
干预措施: Insulin Glargine (Drug)
Insulins + Metformin (MET) + Thiazolidinedione (TZD)
Arm 2: Insulin glargine administered subcutaneously once daily plus metformin and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
干预措施: Insulin Glulisine (Drug)
结局指标
主要结局
Change in Hemoglobin A1c (HbA1c) From Baseline to Week 12
时间窗: 12 weeks from Baseline
次要结局
- Percentage of Subjects Achieving an HbA1C Less Than (<) 7.0% and Less Than (<) 6.5%(60 weeks from Baseline)
- Change From Baseline to End of Study and to Individual Time Points in Components of Lipid Profile (Total Cholesterol, High-density Lipoprotein Cholesterol [HDL], Low-density Lipoprotein Cholesterol [LDL], Triglycerides, LDL Subfractions)(60 weeks from Baseline)
- Change From Baseline to Study Time Points in 7-point Blood Glucose (BG) Profile (Before Meals, 2 Hours After Meals, at Bedtime)(60 weeks from Baseline)
- Change From Baseline to Individual Time Points in HbA1c, Insulin Doses, and Total Insulin Dosage(60 weeks from Baseline)
- Occurrences of Hypoglycemia, Symptomatic Hypoglycemia, Severe Hypoglycemia, and Serious Hypoglycemia(60 weeks from Baseline)
- Rate of Hypoglycemia, Symptomatic Hypoglycemia, Severe Hypoglycemia and Serious Hypoglycemia(60 Weeks from Baseline)