EUCTR2015-001186-46-BE进行中（未招募）1 期
A 28-week, prospective, single-arm, open label phase 4 study to evaluate treatment optimization with once-daily insulin glargine HOE901-300 IU/ml in combination with prandial rapid-acting insulin analogue in patients with type 1 diabetes previously uncontrolled on twice daily basal insulin as part of basal-bolus therapy - OPTIMIZE
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 90
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
- •Male or Female
- •Age = 18 years
- •With Type 1 diabetes mellitus
- •Being treated BID with any basal insulin in combination with prandial rapid-acting insulin analogue for at least one year
- •Have an HbA1c measurement of 8.0% – 10.0% at study entry
- •Patients who have signed an Informed Consent Form
- •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 79
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 23
排除标准
- •Type 2 diabetes mellitus
- •Known hypoglycaemia unawareness
- •Repeated episodes of severe hypoglycemia or DKA within the last 12 months
- •End-stage renal failure or being on hemodialysis
- •Any clinically significant abnormality identified on physical examination, laboratory tests, or vital signs at the time of screening or baseline, or any major systemic disease resulting in short life expectancy that in the opinion of the Investigator would restrict or limit the patient’s successful participation for the duration of the study
- •Known hypersensitivity / intolerance to insulin glargine or any of its excipients
- •Patients treated with GLP-1 receptor agonists
- •Use of systemic glucocorticoids (excluding topical application or inhaled forms) for one week or more within 90 days prior to the time of screening
- •Pregnant or lactating women
- •Women of childbearing potential with no effective contraceptive method
- •Participation in another clinical trial
- •Patient who withdraws consent during the screening or run-in phase (patient who is not willing to continue or fails to return)
- •Patients who cannot demonstrate the proper use of injection pens, diary or glucose meter before receiving the first injection of Insulin glargine HOE901-300 IU/ml
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