NCT05699408已完成3 期
A Randomized, Open-Label, Controlled, Parallel-group, Multicenter Trial Comparing the Efficacy and Safety of INS068 and Insulin Glargine in Subjects With Type 2 Diabetes Mellitus Not Adequately Controlled With Oral Antidiabetic Drugs
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 513
- 试验地点
- 1
- 主要终点
- Change in HbA1c
研究概览
简要总结
The study is being conducted to evaluate the efficacy and safety of INS068 once daily (QD) in subjects with type 2 diabetes not adequately controlled with oral antidiabetic drugs compared to insulin Glargine QD for 26+26 weeks.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with type 2 diabetes ≥ 6 months；
- •Stable daily dose(s) for ≥8 weeks prior to screening of any of the following anti-diabetic drug(s) or combination regimen(s): 1) Any metformin formulations ≥1500 mg daily or maximum tolerated (≥1000mg daily). 2) Any of the following oral antidiabetic drugs with dose ≥half of the maximum approved dose according to local label or maximum tolerated): Sulfonylureas, Meglitinides (glinides), dipeptidyl peptidase-4 (DPP-4) inhibitors, Sodium-glucose co-transporter-2 (SGLT2) inhibitors, Thiazolidinediones and Alpha-glucosidase inhibitors.
- •Glycated hemoglobin was 7.0%~11.0% (both inclusive) at screening
排除标准
- •Known or suspected allergy or intolerance to the investigational medicinal products or related products；
- •Hospitalization for diabetic ketoacidosis or hyperglycemic hyperosmolar syndrome during the previous 6 months；
- •Potentially unstable diabetic retinopathy or maculopathy requiring treatment (e.g., laser, surgical treatment or injectable drugs) during the previous 6 months；
- •Have used insulin therapy anytime in the past 2 years, except for short-term insulin treatment and prior treatment for gestational diabetes.
- •Participation in any clinical trial of an approved or non-approved investigational product/treatment within the last 1 month or 5 half-lives, whichever is longer, prior to screening;
- •Women who are pregnant, breastfeeding or planning to conceive, or women of childbearing potential are reluctant to use appropriate contraception during the trial and for at least 14 days after the last dose of the investigational medicinal drug;
- •Any conditions that the Investigator judges might not besuitable to participate in the trial.
研究组 & 干预措施
Insulin Glargine
Active Comparator
干预措施: Insulin Glargine (Drug)
INS068 injection
Experimental
干预措施: INS068 injection (Drug)
结局指标
主要结局
Change in HbA1c
时间窗: Week 0 to Week 26
Change from baseline in Glycosylated Haemoglobin after 26 weeks of treatment
次要结局
- Frequency and severity of adverse events(Week 0 to Week 52 + 14 days follow-up)
- Incidence and rate of Hypoglycemic events(Week 0 to Week 52 + 14 days follow-up)
- Average daily Insulin dose(Week 0 to Week 26 、Week 0 to Week 52)
- Proportion of Subjects requiring rescue therapy during treatment(Week 0 to Week 26 、Week 0 to Week 52)
- Change in FPG(fasting plasma glucose)(Week 0 to Week 26, Week 0 to Week 52)
- Proportion of Subjects with HbA1c<7% and HbA1c≤6.5%(Week 0 to Week 26 、Week 0 to Week 52)
- per-breakfast SMPG(Week 0 to Week 26 、Week 0 to Week 52)
- 8-point SMPG profiles(Week 0 to Week 26 、Week 0 to Week 52)
- Anti-drug Antibodies(Week 0 to Week 52 + 14 days follow-up)
- Change in scores of diabetes treatment satisfaction questionnaire status version (DTSQs)(Week 0 to Week 26 、Week 0 to Week 52)
- Serum INS068 concentration(Week 0 to Week 52)
- Proportion of Subjects achieving HbA1c targets (HbA1c<7%; HbA1c≤6.5%) and without grade 2 or 3 hypoglycaemia in the last 12 weeks of the treatment period(Week 0 to Week 26, Week 0 to Week 52)
- Change in HbA1c(Week 0 to Week 52)
- Change in weight(Week 0 to Week 26、Week 0 to Week 52)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
To Compare the Efficacy and Safety of INS068 and Insulin Glargine in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin.Type 2 Diabetes MellitusNCT05702073Jiangsu HengRui Medicine Co., Ltd.423
已完成
2 期
Control of Asthma Patients Symptomatic on Inhaled CorticosteroidsAsthmaNCT00330070Inflazyme Pharmaceuticals Ltd200
已完成
2 期
Safety and Efficacy of Ilaprazole 5, 20 and 40 mg QD and Lansoprazole 30 mg QD on Healing of Erosive EsophagitisEsophagitisNCT00471094Takeda831
已完成
不适用
Clinical Evaluation of Approved and Investigational Contact Lenses Using New UV AdditiveVisual AcuityNCT02982018Johnson & Johnson Vision Care, Inc.133
已完成
2 期
Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics of Simeprevir, Daclatasvir and Sofosbuvir in Treatment-naive Participants With Chronic Hepatitis C Virus Genotype 1 InfectionHepatitis C VirusNCT02349048Janssen Research & Development, LLC68