EUCTR2017-001415-36-HU进行中（未招募）1 期
An Open-label, Randomized, Multicenter, Phase III Study to Compare theImmunogenicity, Efficacy, and Safety of Gan & Lee Pharmaceuticals Insulin Glargine Injection to Lantus® (Insulin Glargine Injection) in Adult Subjects with Type 2 Diabetes Mellitus - Insulin Glargine vs Lantus® in Adults with Type 2 Diabetes
Gan & Lee Pharmaceuticals, USA0 个研究点目标入组 554 人开始时间: 2017年12月20日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 554
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male or nonpregnant, nonlactating female subjects between the ages of 18 and 75 years, inclusive
- •2. Ability to provide written, signed, and dated informed consent to participate in the study, in accordance with the ICH GCP Guideline E6 and all applicable regulations, before completing any study-related
- •3. Ability to understand and fully comply with all study procedures and restrictions
- •4. Subjects with a confirmed diagnosis of type 2 diabetes mellitus who meet one of the following:
- •a.If insulin-naïve, subjects should have been on at least 2 approved OAMs for at least 12 weeks before screening, and the clinician has decided to add insulin therapy
- •b.If already being treated with a basal insulin, subjects should have been treated with insulin for at least 6 months in addition to at least 1 approved OAM
- •5. HbA1c values as follows:
- •a.If insulin-naïve, HbA1c = 11.0%
- •b.If previously on a basal insulin regimen, HbA1c = 7.0% and = 11.0%
- •6. Body mass index (BMI) < 45 kg/m2
- •7. Adherence to a prudent diet and exercise regimen recommended by the medical provider, and willingness to maintain these consistently for the duration of the study
- •8. Concomitant medications are allowed, including medications for thyroid disease, provided that a stable dosage has been achieved for at least 90 days before screening, and no significant dosing changes are
- •anticipated during the study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 499
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 55
排除标准
- •1. Participation in another clinical study or use of any study drug within 30 days before screening
- •2. Previous use of a biosimilar insulin, either basal or bolus
- •3. Diabetic ketoacidosis within a year before screening
- •4. Brittle type 1 diabetes mellitus within the year before screening (eg, multiple hospitalizations related to diabetes mellitus and/or severe hypoglycemia for which the subject required 3rd party assistance)
- •5. Any severe, delayed sequela of diabetes mellitus, eg, worsening end-stage renal disease, advanced coronary artery disease, or myocardial infarction within the year before screening, or autonomic peristaltic problems, eg, gastroparesis
- •6. Anticipated change in insulin used during the study (change in dosage is allowed, but change in type or brand of insulin will result in the subject being withdrawn from the study)
- •7. Inadequately controlled thyroid disease, defined as a TSH or free T4 value > the upper limit of normal
- •8. BMI > 45 kg/m2
- •9. Any clinically significant (in the opinion of the Investigator) hematology or chemistry test results at screening, including any liver function test > 3x the upper limit of normal (subjects with elevated
- •bilirubin due to Gilbert syndrome are eligible to participate)
- •10. Documented history of anti-insulin antibodies
- •11. Treatment with glucocorticosteroids, immunosuppressants, or cytostatic agents within 60 days before screening (newly-prescribed or high-dose corticosteroids are prohibited; chronically administered oral,
- •inhaled, topical, or intra-articular corticosteroids at a stable dosage are allowed if no increase in dose is anticipated during the study
- •12. Current use of medication intended to cause weight loss or weight gain
- •13. Alcohol or substance use disorder within the 2 years before screening
- •14. Any previous treatment with interferons
- •15. Any history of malignant disease within 5 years before screening, except for adequately treated basal cell carcinoma
- •16. Severe concomitant physical or psychiatric diseases or conditions
- •17. A history of a positive test result for HIV, hepatitis B, or hepatitis C; any subject who has a positive test result during the study may continue at the discretion of the Investigator
- •18. Any history of pancreatitis or pancreatectomy
- •19. Any diagnosis or condition that requires the subject to undergo procedures that could decrease antibodies in plasma or that would require treatment with immunosuppressant agents
- •20. Any condition eg, splenectomy, autoimmune disease, or rheumatologic disease, that could affect immunologic responses, could indicate an altered immune system, or could require treatment with a
- •prohibited medication
- •21. Any unresolved infection or a history of active infection within 30 days before screening other than mild or viral illness (as judged by the Investigator)
- •22. Any other disease or condition that in the opinion of the Investigator could confound the study results or limit the subject’s ability to participate in the study or comply with follow-up procedures; or any other factor that would indicate a significant risk of loss to follow up
- •23. Intolerance or history of hypersensitivity to insulin glargine or any excipient of the IP
- •24. Inability or unwillingness to wear the CGM sensor as required for the study, or to comply with the concomitant medication requirements regarding the CGM periods
研究者
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