EUCTR2020-000444-58-DE进行中（未招募）1 期
A Phase 2 Trial to Assess the Efficacy and Safety of M1 Pram P037 prandial insulin in T1DM subjects
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Adocia
- 入组人数
- 80
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
- •Signed and dated informed consent obtained before any trial-related activities. Trial
- •related activities are any procedures that would not have been done during normal
- •management of the subject.
- •Male or female subject with type 1 diabetes mellitus.
- •Age between 18 and 64 years, both inclusive.
- •Body Mass Index (BMI) between 25.0 and 35.0 kg/m^2, both inclusive.
- •HbA1c between 7.0 % and 9.5 %, both inclusive
- •Diabetes duration of at least 12 months.
- •Using a multiple dosing insulin therapy (MDI) with a basal insulin and a rapid-acting
- •insulin at at least two meals per day.
- •Using any CGM or FGM for at least 1 month or willing to use CGM during the trial.
- •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 80
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Known or suspected hypersensitivity to IMPs or any of the excipients or to any
- •component of the IMP formulation.
- •Type 2 diabetes mellitus.
- •Previous participation in this trial. Participation is defined as randomised.
- •Receipt of any medicinal product in clinical development within 3 months or at least 5
- •half-lives of the related substances and their metabolites (whichever is longer) before
- •randomisation in this trial.
- •History of multiple and/or severe allergies to drugs or foods or a history of severe
- •anaphylactic reaction.
- •Any history or presence of cancer except basal cell skin cancer or squamous cell skin
- •cancer as judged by the Investigator.
- •Clinically relevant comorbidity, capable of constituting a risk for the subject when
- •participating in the trial or of interfering with the interpretation of data.
- •Clinically significant abnormal screening laboratory tests, as judged by the
- •Investigator.
- •Systolic blood pressure < 90 mmHg or >139 mmHg and/or diastolic blood pressure <
- •50 mmHg or > 89 mmHg (One repeat test (on a different day, if necessary) will be
- •acceptable in case of suspected white-coat hypertension.
- •Clinically significant abnormal standard 12-lead electrocardiogram (ECG) after 5
- •minutes resting in supine position at screening, as judged by the Investigator.
- •Proliferative retinopathy or maculopathy as judged by the Investigator based on a
- •recent (<1.5 years) ophthalmologic examination.
- •Severe neuropathy, in particular autonomic neuropathy, as judged by the
- •Investigator.
- •More than one episode of severe hypoglycaemia with seizure, coma or requiring
- •assistance of another person during the past 6 months.
- •Hypoglycaemic unawareness as judged by the Investigator.
- •Hospitalisation for diabetic ketoacidosis during the previous 6 months.
- •Presence of clinically significant gastrointestinal symptoms (e.g., nausea, vomiting,
- •heartburn or diarrhea), as judged by the Investigator.
- •Confirmed diagnosis of gastroparesis or requiring the use of drugs that alter
- •gastrointestinal motility.
- •Unusual meal habits and special diet requirements that could constitute a risk for the
- •subject when participating in the trial or interfere with the interpretation of data.
- •Significant history of alcoholism or drug abuse as judged by the Investigator or
- •consuming more than 24.0 grams alcohol/day (for males), 12.0 grams alcohol/day (for
- •females) on average.
- •A positive result in the alcohol and/or urine drug screen at the screening visit.
- •Tested positive for Hepatitis Bs antigen.
- •Tested positive for hepatitis C antibodies. (Presence of hepatitis C antibodies will not
- •lead to exclusion if liver function tests are normal and a hepatitis C polymerase chain
- •reaction is negative).
- •Positive result to the test for HIV-1/2 antibodies or HIV-1 antigen.
- •Use of oral antidiabetic drugs (OADs) and/or GLP-1 receptor agonists within 4 weeks
- •prior to screening.
- •Use of systemic glucocorticoid therapy (excluding topical, intraocular, intranasal, intra
- •articular, or inhaled preparations) within 2 months prior to screening.
- •Use or planned use of drugs that promote weight loss (e.g. liraglutide, semaglutide,
- •orlistat, lorcaserin, phentermine) within 2 months prior to screening.
- •Use or planned use of any other systemic medication that could interfere with the
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研究者
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