NCT00384215已完成4 期
Insulin Glargine [rDNA Origin] Injection vs Pioglitazone as add-on Therapy in Patients Failing Monotherapy With Sulfonylurea or Metformin: a Randomized, Open, Parallel Study
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 352
- 试验地点
- 1
- 主要终点
- To determine whether glycemic control as measured by HbA1c is different between insulin glargine [rDNA Origin] injection and pioglitazone when added to subjects who fail monotherapy with SU or metformin.
研究概览
简要总结
This trial will explore the various advantages and possible disadvantages of pioglitazone and insulin glargine when added to monotherapy. Glycemic control, hypoglycemia, weight, lipid profiles, quality of life and cost will be studied given a comprehensive set of data that may help future treatment decisions.
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
- •The following information on clinical trials is provided for information purposes only to allow patients and physicians to have an initial discussion about the trial. This information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional.
- •INCLUSION CRITERIA:
- •Diagnosis of type 2 diabetes mellitus for at least six months
- •Continuous treatment with at least 1g metformin or half maximally labeled dose of a SU daily for at least three months
- •HbA1c >/= 8 % and </= 12%, inclusive, as measured at screening week
- •Willingness to accept, and demonstrated ability to inject insulin glargine therapy
- •Demonstrated ability and willingness to perform SMBG using a plasma-referenced glucose meter at least twice a day
- •Ability to understand and willingness to adhere to and be compliant with the study protocol
排除标准
- •Stroke, myocardial infarction (MI), coronary artery bypass graft (CABG), percutaneous transluminal coronary angioplasty (PTCA) or angina pectoris within the last 12 months
- •Congestive heart failure requiring pharmacological treatment
- •Impaired renal function, as shown by but not limited to serum creatinine >/= 1.5 mg/dl (133µmol/L) for males, or >/= 1.4 mg/dl (124 µmol/L) for females
- •Treatment with non-selective beta-blockers (including ocular)
- •Acute infection
- •History of or presence of signs of significant peripheral edema
- •Acute or chronic or history of metabolic acidosis, including diabetic ketoacidosis
- •Planned radiological examinations requiring administration of contrasting agents
- •Clinical evidence of active liver disease, or serum ALT 2.5 times the upper limit of the normal range
- •History of hypoglycemia unawareness
- •Pregnant or breastfeeding females
- •Failure to use adequate contraception (women of current reproductive potential only)
- •BMI < 25 kg/(m)(m)
- •Treatment with systemic steroids or large doses of inhaled steroids
- •Treatment with any diabetes medication other than the medications required by this study
- •Use of an investigational drug within the previous month
- •Known hypersensitivity to insulin glargine, pioglitazone or any of the components of insulin glargine and pioglitazone
- •Any malignancy within the last five years, except adequately treated basal cell carcinoma and adequately treated cervical carcinoma in situ.
- •Current addiction or alcohol abuse or history of substance or alcohol abuse within two years
- •Diagnosis of dementia
- •Any disease or condition that in the opinion of the investigator and/or sponsor may interfere with completion of the study or interpretation of study results
- •Inability to comply with study procedures
结局指标
主要结局
To determine whether glycemic control as measured by HbA1c is different between insulin glargine [rDNA Origin] injection and pioglitazone when added to subjects who fail monotherapy with SU or metformin.
次要结局
- Compare occurrence of hypoglycemia
- Compare change in body weight
- Compare change in FPG
- Compare change in serum lipid profile
- Compare percentage of subjects achieving HbA1c levels </= 7%
- Compare the time until an HbA1c </= 7% is achieved
- Compare change in HRQOL
- Compare cost of therapy for hyperglycemia treatment
研究者
研究点 (1)
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