EUCTR2014-004533-13-AT进行中（未招募）不适用
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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 148
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 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 eligible,
- •-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.
- •-Severe or uncontrolled Congestive Heart Failure (New York Heart
- •Association [NYHA] functional classification III and IV); or inadequately controlled hypertension at the time of screening with a resting systolic or diastolic blood pressure >180 mmHg or >95 mmHg, respectively.
- •Pregnant or breast-feeding women or women who intend to become
- •pregnant during the study period as glycemic control may be unstable
- •and insulin doses may be variable during this period.
- •Women of childbearing potential (premenopausal, not surgically sterile
- •for at least 3 months prior to the time of screening) must use an effective contraceptive method throughout the study. Effective methods of contraception include barrier methods (in conjunction with spermicide), hormonal contraception, or use of an intrauterine device (IUD) or
研究者
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