The Study of Stepwise Introduction of Insulin Analog Mixture as a Post-marketing Clinical Trial of Lispro Mix 50/50 to Evaluate Efficacy and Safety in Type 2 Diabetic Patients With Inadequate Glycemic Control on Oral Therapy. (SIMPLE Study)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- Percentage of Participants Achieving Hemoglobin A1c (HbA1c) Below 6.5% at Week 48 Endpoint
研究概览
简要总结
The purpose is to evaluate the proportion of subjects achieving a Hemoglobin A1c (HbA1c) level below 6.5%, when lispro mix 50/50 is introduced in a stepwise manner from every day (QD) administration to type 2 diabetic patients who have failed to achieve adequate glycemic control on oral antidiabetic drugs (OADs).
详细描述
A multicenter, non-randomized, open-label, post-marketing clinical study. The target population of the study is type 2 diabetic patients who have failed to achieve adequate glycemic control on OADs. The study consists of 4 periods: Lead-in Period (2 to 4 weeks), Study Period I (16 weeks), Study Period II (16 weeks), and Study Period III (16 weeks). The regimen of lispro mix 50/50 injection will be changed every 16 weeks based on the HbA1c level. During Study Period I, all the subjects will be given a once daily (QD) injection of lispro mix 50/50. During Study Period II, the regimen of lispro mix 50/50 injection will be changed to twice daily (BID) if the HbA1c level at Week 16 is 6.5% or above, and QD injection will be continued if the value is below 6.5%. During Study Period III, if the HbA1c level at Week 32 is 6.5% or above, the subjects on BID treatment during the previous period (Study Period II) will receive three times daily (TID) injections of insulin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed as having type 2 Diabetes.
- •Patients who have not been on insulin treatment within 6 months.
- •Patients who have been taking OADs for at least 90 days.
- •Patients with an HbA1c level in the range of 7.5% to 11.0%.
- •Patients with a Body-Mass Index (BMI) of 35 kg/m² or below.
排除标准
- •Patients having pre-proliferative or proliferative retinopathy (except for old retinopathy with no need for treatment).
- •Patients having or suspected of having malignancy
- •Patients having serious complications of the heart, liver, or kidney.
- •Patients hypersensitive or allergic to insulin or insulin analog preparations or a history of it.
- •Patients receiving systemic steroids.
- •Are currently enrolled in a clinical trial of a non-approved drug. Or patients who participated in other clinical trials including post-marketing clinical trials within 90 days prior to informed consent being obtained.
- •Patients of child-bearing potential. Breastfeeding patients. Patients with a positive result in a pregnancy test performed for women of child-bearing potential.
研究组 & 干预措施
Lispro 50/50
干预措施: Lispro Mix 50/50 (Drug)
结局指标
主要结局
Percentage of Participants Achieving Hemoglobin A1c (HbA1c) Below 6.5% at Week 48 Endpoint
时间窗: Week 48
Hemoglobin A1c (HbA1c) is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. The 6.5% HbA1c is the Japan Diabetes Society (JDS) value, and is equivalent to the National Glycohemoglobin Standardization Program (NGSP) HbA1c value of 6.9%.
次要结局
- Percentage of Participants Achieving Hemoglobin A1c (HbA1c) Below 6.5% at Week 16 and Week 32 Endpoints(Week 16 and Week 32)
- Percentage of Participants Achieving Hemoglobin A1c (HbA1c) Below 7.0% at Week 16, 32 and 48 Endpoints(Week 16 and Week 32 and Week 48)
- Percentage of Participants Achieving Hemoglobin A1c (HbA1c) Level Below 6.5% and Below 7.0% by Regimen at Week 48 Endpoint(Week 48)
- Change From Baseline in Hemoglobin A1c (HbA1c) at Week 48 Endpoint(Baseline, Week 48)
- Change From Baseline in Fasting Glucose at Week 48 Endpoint(Baseline, Week 48)
- Change From Baseline in Blood Glucose Profile at Week 48 Endpoint(Baseline, Week 48)
- Change From Baseline in Fasting C-Peptide at Week 48 to Endpoint(Baseline, Week 48)
- Change From Baseline in Fasting Serum Lipids at Week 48 Endpoint(Baseline, Week 48)
- Change From Baseline in Body Weight at Week 48 Endpoint(Baseline, Week 48)
- Total Daily Dose of Insulin at Baseline, Week 16, Week 32 and Week 48(Baseline and Weeks 16, 32 and 48)
- Percentage of Participants Developing Hypoglycemia at Any Time From Baseline Through Week 48(Baseline through Week 48)
- Number of Hypoglycemia Episodes Participants Experienced at Any Time From Baseline Through Week 48(Baseline through Week 48)