EUCTR2014-004533-13-DE进行中（未招募）1 期
A 21-Week, Open-label, Randomized, Controlled, Parallel-group, Multi-center Study Evaluating the Efficacy and Safety of HOE901-U300 Administered According to a Device-Supported Treat-to-target Regimen Versus Routine Titration in Patients with Type 2 Diabetes Mellitus - AUTOMATIX
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 151
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
- •Patients with type 2 diabetes mellitus diagnosed at least one year before the screening visit.
- •Patients who are insulin naïve (and considered by the investigator to be appropriate candidates for basal insulin therapy), or treated with basal insulin as their only insulin.
- •HbA1c between 7.5% and 11% (inclusive) at screening.
- •Fasting SMPG >130 mg/dL at first screening and FSMPG >130 mg/dL at randomization.
- •Signed informed consent.
- •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 111
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 37
排除标准
- •Aged <18 years.
- •Diabetes other than type 2 diabetes mellitus.
- •MyStar DoseCoach device is not appropriate for the patient or use of
- •device is otherwise contraindicated (in the opinion of the Investigator).
- •Conditions/situations that are contraindications or off-label use
- •XML File Identifier: BFURztnmICdH90SHcWgWTsI/A8k=
- •according to Summary of Product
- •Characteristics (SmPCs) of Oral Anti-Diabetes Drugs (OADs) and/or GLP-
- •1 receptor agonists when applicable (prescribed), or insulin glargine and
- •as defined in the national product label.
- •Patients not on stable dose of glucose lowering therapy including OADs,
- •GLP-1 receptor agonists, or basal insulin therapy, for the last 3 months
- •(stable basal insulin therapy defined as maximum change in insulin dose
- •of +/- 20%).
- •Patients using mealtime insulin (short acting analogue, human regular
- •insulin or premix insulin) for more than 10 days in the last 3 months
- •before screening visit.
- •Patients with hypoglycemia unawareness.
- •Patients with severe hypoglycemia in the past 90 days.
- •Hospitalization in the past 30 days.
- •Use of systemic glucocorticoids (excluding topical application or inhaled
- •forms) for one week or more within 90 days prior to the time of
- •Unable to meet specific protocol requirements (eg, inability to perform
- •blood glucose measurements, manage their own insulin glargine
- •administration, or deemed unlikely to safely manage titration based on
- •guidance by their health care provider or HCP, etc.), because of a
- •medical condition or because the patient is under legal guardianship.
- •-Patients with cognitive disorders, dementia, or any neurologic disorder
- •that would affect a patient's
- •ability to participate in the study, including the inability to understand
- •study requirements or to give
- •complete information about adverse symptoms.
- •-Conditions/situations such as:
- •-Patients with conditions/concomitant diseases precluding their safe
- •participation in this study
- •(eg, active malignant tumor, major systemic diseases, presence of
- •clinically significant diabetic
- •retinopathy or presence of macular edema likely to require treatment
- •within the study period, etc.),
- •-Patients unable to fully understand study documents and to complete
- •them. Patients who have a
- •caregiver together with whom they can fulfill all study requirements are
- •-Patient is the Investigator or any Sub-Investigator, research assistant,
- •pharmacist, study
- •coordinator, other staff or relative thereof directly involved in the
- •conduct of the protocol.
- •-Within the last 3 months prior to screening: history of myocardial
- •infarction, unstable angina, acute
- •coronary syndrome, revascularization procedure, or stroke requiring
- •hospitalization.
- 另有 13 项未显示
研究者
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