CTRI/2019/08/020701尚未招募4 期
A multicenter, multinational, prospective, interventional, single-arm, Phase IV study evaluating the clinical efficacy and safety of 26 weeks of treatment with insulin glargine 300 U/mL (Gla-300) in patients with Type 2 diabetes mellitus uncontrolled on basal insulin
SanofiAventis Groupe0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Type of participant and disease characteristics
- •I 02. Participants with T2DM.
- •I 03. Participants on â??standard of careâ?? basal insulin therapy (including Gla-100, detemir, degludec, NPH insulin), administered once or twice daily, as per labeling for at least 6 months prior to screening visit, with or without oral agents (metformin, sulfonylurea, thiazolidinedione, DPP-4 inhibitor, SGLT-2 inhibitor, glinide, α-glucosidase inhibitor) and with or without use of a GLP-1 receptor agonist, approved for using with insulin.
- •I 04. HbA1c between 7.5% (58 mmol/mol) and 10% (86 mmol/mol) inclusive, during screening.
- •I 05. Median of the last 3 consecutive fasting SMPG values prior to baseline, or at least 2 fasting SMPG values in the week prior to baseline >130 mg/dL
- •I 06. Male or Female
- •- Female participants: A female participant is eligible to participate if she is not pregnant not breastfeeding, and at least 1 of the following
- •conditions applies:
- •- Not a woman of childbearing potential (WOCBP)
- •- A WOCBP who agrees to follow the contraceptive guidance during the intervention period and for at least 1 week after the last dose of study intervention (ie, until Week 27).
- •Informed Consent
- •I 07. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
排除标准
- •Medical conditions
- •E 01. Any clinically significant abnormality identified either in medical history or during screening evaluation (eg, physical examination, laboratory tests, electrocardiogram, vital signs) or any AEs during screening period which in judgment of the Investigator would preclude safe completion of the study or constrains efficacy assessment.
- •E 02. Known presence of factors that interfere with the HbA1c measurement (eg, specific hemoglobin variants, hemolytic anemia) compromising the reliability of HbA1c assessment or medical conditions that affect interpretation of HbA1c results (eg, blood transfusion or severe blood loss in the last 3 months prior to baseline, any condition that shortens erythrocyte survival).
- •E 03. History of severe hypoglycemia requiring emergency room admission or hospitalization
- •within 3 months prior to screening visit.
- •E 04. Proliferative retinopathy or maculopathy requiring treatment according to the Investigator.
- •Prior/concomitant therapy
- •E 05. Unstable basal insulin regimen in the last 8 weeks prior to screening visit (ie, type of
- •insulin and time/frequency of the injection, insulin doses [variation more than ±20%]).
- •E 06. Treatment with insulin other than basal insulin: mixed insulin (premixes), rapid insulin,
- •and fast acting insulin analogues in the last 6 months before screening visit (use <=10 days
- •in relation to hospitalization or an acute illness is accepted).
- •E 07. Use of non-insulin antidiabetic drugs other than those listed in inclusion criteria.
- •E 08. Change in existing dose or initiation of new, non-insulin antidiabetic drugs in the 8 weeks
- •prior to screening visit.
- •E 09. Use of systemic glucocorticoids (excluding topical application or inhaled forms) for
- •2 weeks or more within 8 weeks prior to screening visit.
- •E 10. Likelihood to require treatment prohibited by the protocol during the study.
- •Prior/concurrent clinical study experience
- •E 11. Exposure to any investigational drugs in the last 4 weeks or 5 half-lives, whichever is
- •longer, prior to screening visit or concomitant enrollment in any other clinical study
- •involving an investigational study treatment.
- •Diagnostic Assessments
- •Not applicable
- •Other exclusions
- •E 12. Any specific situation during study implementation/course that may raise ethics
- •considerations.
- •E 13. History of hypoglycemia unawareness.
- •E 14. Known hypersensitivity/intolerance to Gla-300 or any IMP excipients.
- •E 15. History of drug or alcohol abuse within 6 months prior to screening visit.
- •Additional criteria at the end of the screening period
- •E 16. Participants unwilling or unable to comply with study procedures as outlined in the
- •E 17. Participants who withdraw consent during the screening (starting from signed ICF).
研究者
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