A Phase III, Randomized, Parallel, Double Blind, Non-inferiority, Multicenter Study to Compare Efficacy, Safety and Immunogenicity of VBLG01 to Victoza in Patients With Type 2 Diabetes
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 226
- 试验地点
- 10
- 主要终点
- Mean change in reduction in the HbA1c from baseline to 24 weeks
研究概览
简要总结
The current study is a double-blind, randomized phase III comparative clinical study expected to be conducted on 226 patients with type 2 diabetes. The study expected to last for a maximum of 26 weeks/patient. Visit 1 will be considered as screening visit. On visit 2 (day 1) patients will be receiving the investigational products as per the randomization along with oral antidiabetic drugs (OADs) like metformin and/or sulfonylureas and/or alpha glucosidase inhibitors and/or sodium-glucose co-transporter 2 (SGLT2) inhibitors. Patients will continue the treatment (liraglutide and OADs) from visit 3 to visit 11. Visit 12 will be study termination visit. In addition, patients will be further follow-up for one week for safety assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
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 treated with oral antidiabetic drugs (OADs) like metformin and/or sulfonylureas and/or alpha glucosidase inhibitors and/or sodium-glucose co-transporter 2 (SGLT2) inhibitors at stable dose for at least 3 months before screening.
- •Patients with glycosylated hemoglobin ≥7 to ≤10%.
- •Patients with a body mass index of greater than or equal to 23 kg/m2 and less than or equal 45 kg/m
- •Women of childbearing potential should agree to use suitable method of contraception throughout the study.
- •Ability and willingness to take daily injections to abdomen, thigh or upper arm.
- •Ability and willingness to adhere to the protocol requirements.
排除标准
- •1.Patients with significant liver, cardiac or gastrointestinal disease. 2.Hypersensitivity to liraglutide or any component of the formulation. 3.Insulin treatment during the previous 3 months.
- •except short-term treatment for intercurrent illness. 4.Impaired liver function.
- •(ALT, AST, ALP concentrations greater than or equal to 2·5 times upper normal range.
- •Impaired renal function.
- •eGFR lessthan 60 mL/min/1.73 m2). 6.Uncontrolled hypertension greater than or equal to160/100 mm Hg. 7.Malignancy. 8.Used any drugs apart from OGLAs likely to affect glucose concentrations, including androgens, hyperglycaemia-associated agents, hypoglycaemia-associated agents, MAO inhibitors, quinolone antibiotics, salicylates -Anti-inflammatory dose. 9.Treatment with dipeptidyl peptidase 4 inhibitors. 10.Treatment with systemic corticosteroids. 11.History or family history of medullary thyroid carcinoma. 12.Multiple endocrine neoplasia syndrome type
- •13.History of pancreatic cancer and pancreatitis. 14.History of recent MI, uncontrolled CHF, and unstable angina. 15.History or known case of severe non-proliferative diabetic retinopathy or proliferative diabetic retinopathy. 16.Pregnancy. 17.Previous exposure to exenatide or liraglutide.
结局指标
主要结局
Mean change in reduction in the HbA1c from baseline to 24 weeks
时间窗: Mean change in reduction in the HbA1c from baseline to 24 weeks
次要结局
- 1.Mean change in fasting plasma glucose (FPG) from baseline to 24 weeks.(2.Mean change in post-prandial blood sugar (PPBS) from baseline to 24 weeks.)
研究者
Dr Hemanth Nandigala
Virchow Biotech Private Limited