EUCTR2014-001253-16-DE进行中（未招募）1 期
A multi-center, open-label, single-arm, multiple dose study with HOE901-U300 to assess the Ease of Use and Safety of a new U300 pen injector in insulin-naïve patients with T2DM
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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 T2DM inadequately controlled with non-insulin, noninjectable antihyperglycemic drug(s) and for whom the
- •Investigator/treating physicians has decided that basal insulin is appropriate.
- •Signed written 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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •Glycated hemoglobin A1c (HbA1c) <7.0% (<53 mmol/mol) or >11% (97 mmol/mol) at screening.
- •Age <18 years at the time of screening.
- •Body Mass Index (BMI) >40 kg/m2.
- •Diabetes other than T2DM.
- •History of T2DM for less than 1 year before screening.
- •Less than 6 months anti-hyperglycemic treatment before screening.
- •Initiation of new glucose-lowering medications and/or weight loss drug in the last 3 months before screening visit.
- •Previous treatment with Glucagon Like Peptide-1 (GLP-1) agonist.
- •Patients receiving only non-insulin anti-hyperglycemic drugs not approved for combination with insulin according to local labeling/local treatment guidelines and/or sulfonylurea or glinides.
- •Current or previous insulin use except for a maximum of 8 consecutive days and a total of 14 days (eg, acute illness, surgery) during the last year prior to screening.
- •Any contraindication to insulin glargine (Lantus) according to the National Product labeling or any excipients.
- •Any contraindication to the mandatory background non-insulin antihyperglycemic medication according to the respective National Product labeling.
- •Latest eye examination by an ophthalmologist >12 months prior to inclusion.
- •More than one episode of severe hypoglycemia with seizure, coma or requiring assistance of another person during the past 6 months.
- •Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment (eg, laser, surgical treatment or injectable drugs) during the study period)
研究者
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