A Prospective, Multicentric, Randomized, Open-Label Comparison of a Long-Acting Basal Insulin Analog Glargine Plus Glulisine With Premixed Insulin in Adult Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 8
- 主要终点
- Changes in HbA1c
研究概览
简要总结
This study is a multicentre, randomized, open label on comparison of a Long-Acting Basal Insulin Analog Glargine plus Glulisine with Premixed Insulin in Adult Patients with Type 2 Diabetes Mellitus in 200 patients that will be conducted in seven centers in Tamil Nadu. The primary outcome measures will be to compare the change in HbA1c from baseline to week 24 between Glargine OD + Glulisine in comparison with Premixed insulin initiation in insulin naïve patients with T2DM. The secondary outcomes is to compare the following in the two arms between baseline and 24 weeks Fasting plasma glucose, Postprandial glucose, 7-point self-monitored blood glucose (SMBG) profiles, Percentage of participants with HbA1c < 7%, Insulin dose, Overall adverse events, Symptomatic Hypoglycemia, Severe hypoglycemic, Weight, BMI and Blood pressure.
详细描述
The subjects will be invited to the study centre from the local population who are willing to participate in the trial. Each subject will be informed both orally and in writing about the study prior to inclusion in the study and only the subjects who give written informed consent will be included. The selection of the subjects is based on the inclusion and exclusion criteria defined in the protocol. The selected subjects will be given a screening number and subjected to screening procedure to find out eligible candidates for enrollment. The screening procedure includes obtaining subject's anthropometric data, baseline symptomatology, medical history, vital signs, physical examination, laboratory investigations like blood glucose (fasting & 2hr after meal), HbA1c, Urea, Creatinine, Liver function test, Lipid profile, Urine albumin/creatinine ratio, urine pregnancy (if applicable) and ECG.
This will be followed by 2 weeks run in period for eligible patients to ensure patients are on stable dose of oral therapy and Metformin not < 1500 mg/day. Sulfonylurea will be stopped.
All the eligible patients as per the inclusion criteria (HbA1c ≥7.5% to ≤ 10.5%, fasting blood glucose ≥ 150 mg/dl, and/or Postprandial blood glucose ≥ 200 mg/dl) will be randomized in two arms. Participants in arm-1 will receive once daily insulin Glargine (12 units) plus once daily Glulisine (4 units) at breakfast/dinner, along with OHAs at stable dose and titrated optimally. Participants in the arm-2 will receive once daily premix analogue insulin (30/70) 16 units at breakfast/dinner, along with OHAs at stable dose and will be titrated as per the treatment algorithm.
During the randomization visit, the selected subjects after the run in period will be given a subject number and randomized between two arms.
Anthropometric measurements and vital sign will be taken. Concomitant medication and adverse events will be noted. Glucose meter, strips, Insulin and study diary will be dispensed. Training on Glucose meter usage, hypoglycemia, hyperglycemia symptoms, Insulin injection technique and dose titration technique will be done. Subjects will be instructed to maintain the record of dosing details in the patient diary. They will be given Diet and Exercise counselling. They will be asked to hand over the study diary and Insulin pen (empty or full) to the coordinator at each visit.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Insulin naïve men and women with T2DM on stable dose of 2 or 3 OHAs for at least 3 months.
- •Both men and women of age ≥ 18 and ≤ 65 years.
- •Have an HbA1c ≥ 7.5% and ≤ 10.5% with fasting blood glucose ≥ 150 mg/dl, and/or Postprandial blood glucose ≥ 200 mg/dl
- •Body mass index (BMI) ≤ 40 kg/m
- •Have given written informed consent to participate in this study in accordance with local regulations.
- •Subject must have access to telephone for calling into the clinical center as part of test product compliance.
排除标准
- •Type 1 diabetes
- •BMI > 40 kg/m2
- •Subject is being treated for severe active infection of any type
- •Have had more than one episode of severe hypoglycemia within 6 months prior to entry into the study.
- •Planned surgery in the next 6 months
- •Any event forecasted to require a temporary need to switch to insulin
研究组 & 干预措施
Glargine + Glulisine
Insulin Glargine + Glulisine (12U/day + 4U/day) at pre-breakfast/dinner for 24 weeks
干预措施: Glargine + Glulisine (Drug)
Premixed Analogue Insulin (70/30)
Premixed analogue Insulin (70/30) 16U/day at pre-breakfast/dinner for 24 weeks
干预措施: Premixed analogue insulin (70/30) (Drug)
结局指标
主要结局
Changes in HbA1c
时间窗: Baseline and 24 weeks
To compare the change in HbA1c from baseline to week 24 between Glargine OD + Glulisine in comparison with Premixed insulin initiation in insulin naïve patients with T2DM
次要结局
- Changes in postprandial blood glucose(Baseline and 24 weeks)
- Percentage reduction of HbA1c < 7%(Baseline and 24 weeks)
- Changes in weight(Baseline and 24 weeks)
- Changes in 7 point self monitored blood glucose profile(Baseline and 24 weeks)
- Number of events of symptomatic hypoglycemia(Baseline and 24 weeks)
- Changes in Fasting Blood Glucose(Baseline and 24 weeks)
- Number of events of severe hypoglycemia(Baseline and 24 weeks)
- Number of participants treated related to adverse events(Baseline and 24 weeks)
- Changes in Insulin dose(Baseline and 24 weeks)
- Changes in Body mass index(Baseline and 24 weeks)
- Changes in blood pressure(Baseline and 24 weeks)