CTRI/2024/11/076296已完成3 期
A Phase III, Randomized, Controlled, Open-Label, Multicenter, Parallel Comparative study to assess the Efficacy and Safety of VB70G (Insulin Glargine Injection 100 Units/mL) with LANTUS in Type 2 Diabetes Mellitus patients with Uncontrolled Oral Antidiabetic therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 230
- 试验地点
- 14
- 主要终点
- Change in Hb1Ac from baseline to 24 weeks
研究概览
简要总结
This is a phase III, randomised, controlled, comparative, open-label, multicenter study in India. The duration of the study for each subject is 29 weeks, which includes a 1-week screening period, 24 weeks treatment and follow-up visit after 4 weeks of 6 months treatment.As per the randomization the drugs to be administered 10 units or 0.2 units/kg once daily subcutaneously before sleep along with oral antidiabetic. The dose of recombinant insulin glargine needs to be adjusted till FPG value is ≤120 mg/dL is achieved. Dose to be adjusted at every 3 days by 2 units upto a maximum of 100 units. Investigators can decrease the insulin dose for patients who experience hypoglycemia on their active dose. All the patients will be followed for 4 weeks post treatment safety after 6 months duration
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female patients aged between 18 – 65 years.
- •Patients with Type 2 diabetes mellitus based on the disease diagnostic criteria of World Health Organization (WHO) classification ([fasting plasma glucose ≥ 7.0mmol/l (≥126mg/dl) or 2–h plasma glucose ≥ 11.1mmol/l (≥200mg/dl)].)
- •Patients who have been taking at least 2 types of oral diabetes medications [≥ two drugs- AGI (α-Glucosidase inhibitors), DPP-4 (Dipeptidyl peptidase-4) inhibitors, MEG (Meglitinides), MET (metformin), SU (Sulfonylureas)] for at least 12 weeks prior to entering the study.
- •Patients with HbA1c ≥7% and ≤10%.
- •Patients with a body mass index of less than or equal to 35 kg/m2.
排除标准
- •Type 1 diabetes mellitus patients.
- •Patients with significant liver, cardiac or gastrointestinal disease.
- •Patients with active cancer or have had cancer within the past 5 years (with the exception of basal cell carcinoma or carcinoma in situ)
- •Patients who are having an excessive resistance to insulin or hypersensitivity to insulin glargine.
- •Patients who had more than one episode of severe low blood sugar (defined as needing someone else to help because of very low blood sugar) within the 6 months before entering the study
- •Patients who have taken any other insulin other than insulin glargine within the past 30 days
- •Taking any other diabetes medicines that are not allowed in the study or not approved to be taken with insulin.
- •Patients on self-monitoring of blood glucose less than 6 months before screening visit;
- •Patients using pre-mix insulins, insulin detemir at 2 times or more a day, or GLP 1 receptor agonists in the last 3 months before screening visit;
- •Patients using mealtime insulin (rapid-acting insulin analogue and short-acting insulin) for more than 10 days in the last 3 months before screening visit;
- •Use of insulin pump in the last 6 months before screening visit;
- •Initiation of new glucose-lowering medications and/or weight loss drugs in the last 3 months before screening visit;
- •Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular oedema likely to require treatment (eg, laser, surgical treatment or injectable drugs) during the study period.
结局指标
主要结局
Change in Hb1Ac from baseline to 24 weeks
时间窗: Week 24
次要结局
- Change in FPG from baseline to 24 weeks
研究者
Dr Hemanth Nandigala
Virchow Biotech Private Limited
研究点 (14)
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