LBCTR2019040212Other4 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 - ARTEMIS-DM
适应症
试验速览
- 阶段
- 4 期
- 状态
- Other
- 发起方
- Sanofi
- 入组人数
- 11
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 至 90（—）
- 性别
- All
入选标准
- •Protocol: Page 26-27
- •Participants are eligible to be included in the study only if all of the following criteria apply:
- •I 01. Participants must be >18 years of age (inclusive), at the time of signing the informed
- •-Type of participant and disease characteristics
- •I 02. Participants with T2DM.
- •I 03. Participants on standard of care” 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, a-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) as defined in Appendix 4
- •(Section 10.4).
- •- A WOCBP who agrees to follow the contraceptive guidance in Appendix 4
- •(Section 10.4) 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 as described in Appendix 1 (Section 10.1.3)
- •which includes compliance with the requirements and restrictions listed in the informed
- •consent form (ICF) and in this protocol.
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •-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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