NCT00405418已完成4 期
Target Glycemic Control and the Incidence of Documented Symptomatic Hypoglycemia in Insulin naïve Subjects With Type 2 Diabetes Failing on Oral Hypoglycemic Agent(s) and Treated With Insulin Glargine or Insulin Detemir.
适应症
干预措施
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
- 973
- 试验地点
- 1
- 主要终点
- HbA1c recorded
研究概览
简要总结
Primary objective:
To demonstrate the non-inferiority of insulin glargine in comparison to insulin detemir in term of percentage of patients who reach the target of HbA1c < 7% at the end of the treatment period and do not experience symptomatic hypoglycemia, confirmed by plasma glucose (PG) ≤ 56 mg/dL (3.1 mmol/L)
Secondary objectives:
- To compare between the 2 treatment groups, the percentage of patients who reach the target of HbA1c < 7% and < 6.5% at the end of the treatment period
- To compare the changes in HbA1c and fasting plasma glucose (FPG)
- To compare the evolution of blood glucose profiles
- To compare the day to day FPG variability, the insulin doses
- To determine in each treatment group the biochemical and patient-related determinants of failure to reach HbA1c targets
- To compare the overall incidence and rate of symptomatic hypoglycemia and nocturnal symptomatic hypoglycemia confirmed by PG ≤ 56 mg/dL (3.1 mmol/L)
- To compare over the treatment period, the overall incidence and rate of symptomatic hypoglycemia and symptomatic nocturnal hypoglycemia (with PG ≤ 70 mg/dL [3.9 mmol/L]), of symptomatic day-time hypoglycemia (with PG ≤ 70 mg/dL and with PG ≤ 56 mg/dL), of severe hypoglycemia, of asymptomatic hypoglycemia with PG ≤ 56 mg/dL
- To compare the overall safety: incidence of adverse events (including serious hypoglycemia and local tolerance at injection site), change in body weight, in waist circumference and in waist / hip ratio
- To assess the quality of life and treatment satisfaction
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
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes for at least 1 year
- •Insulin naïve
- •Treated with stable doses of oral antidiabetics for at least 3 months prior to study start, including at least metformin (at least 1g/day)
- •7% ≤ HbA1c ≤ 10.5 %
- •Body mass index (BMI) < 40 kg/m²
- •Ability and willingness to perform blood glucose monitoring using a blood glucose meter and to use a patient diary
排除标准
- •Type 1 diabetes
- •Current or previous use of insulin (except for previous treatment of gestational diabetes or brief treatment with insulin for less than 1 week)
- •Treatment with glucagon-like peptide (GLP)-1 receptor agonists or with dipeptidyl peptidase (DPP)-IV inhibitors
- •Active proliferative diabetic retinopathy, as defined by the application of photocoagulation or surgery, in the 6 months before study entry or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgery during the study (an optic fundus examination should have been performed in the 2 years prior to study entry)
- •Pregnancy (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraceptive method)
- •Breast-feeding
- •History of hypersensitivity to the study drugs or to drugs with a similar chemical structure
- •Treatment with systemic corticosteroids in the 3 months prior to study entry
- •Treatment with any investigational product in the 2 months prior to study entry
- •Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol
- •Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major disease making implementation of the protocol or interpretation of the study results difficult
- •Impaired hepatic function as shown by Alamine aminotransferase (ALT) and/or Aspartate aminotransferase (AST) greater than three times the upper limit of normal range at study entry
- •Impaired renal function as shown by serum creatinine ≥ 1.5 mg/dL (≥ 133 μmol/L) in men and ≥ 1.4 mg/dL (124 μmol/L) in women at study entry
- •History of drug or alcohol abuse in the last year
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
1
Experimental
Insulin Glargine
干预措施: Insulin glargine (Drug)
2
Active Comparator
Insulin Detemir
干预措施: Insulin Detemir (Drug)
结局指标
主要结局
HbA1c recorded
时间窗: At baseline, week 12 and week 24
Self-monitored fasting BG in both treatment arms and pre-dinner BG in detemir arm
时间窗: On the 4 consecutive days before each visit
Self-monitored BG values from 8-point 24-hour profile recorded on 2 consecutive days
时间窗: Within the week prior to baseline, week 12 and week 24
Episodes of hypoglycemia (symptomatic, total and categorized as day-time/nocturnal, severe or asymptomatic)
时间窗: All across the study
Self-monitored BG values whenever patient experiences symptoms possibly related to hypoglycemia.
时间窗: All across the study
次要结局
- Doses of insulin glargine or insulin detemir(Daily)
- Laboratory fasting plasma glucose(At baseline, week 12 and week 24)
- Insulinemia and fasting C-peptide level(At baseline)
- Systolic and diastolic blood pressure(measured at study entry, baseline, week 12 and week 24)
- Physical examination(performed at study entry and at last visit.)
- Lipid profile(at baseline and week 24)
- Patient reported outcomes (quality of life and treatment satisfaction)(at baseline, week 4, week 12 and at the last visit)
- Safety data: occurrence of adverse events and weight(assessed at each visit)
- Waist and hip circumferences(measured at baseline, week 12 and week 24)
研究者
研究点 (1)
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