EUCTR2017-004944-39-HU进行中（未招募）1 期
A 24 Week, Phase IIa, Double blind, Randomized, Parallel Group, Placebo-controlled, Proof of Concept Study to Assess the Efficacy and Safety of Two Doses of 5 Aminolevulinic Acid Co-administered with Sodium Ferrous Citrate in Adult Patients with Type 2 Diabetes Mellitus - Phase IIa Double-blind Proof of Concept Study of Two Doses of 5-ALA Co-administered with SFC in T2DM
neopharma Japan Co., Ltd0 个研究点目标入组 216 人开始时间: 2018年5月7日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 216
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
- •1. Male or female between 18 and 75 years old (age <18 to age =75) at time of informed consent, with a documented diagnosis of T2DM for at least 6 weeks before enrolment.
- •2.Written and signed informed consent needs to be provided by patients who are legally capable before starting any protocol-specific procedures.
- •For patients treated with anti-diabetic medication between 6.5% and 9.0% (both inclusive) at Screening (Visit 1) and between 6.5% and 9.5%, inclusive, at Run-in (Visit 3) based on central laboratory results.
- •For anti-diabetic treatment free patients – between 6.5% and 9.5% at Screening (Visit 1), based on central laboratory results
- •4. Currently treatment free patients for anti-diabetic medication, or treated with a single therapy of oral anti-diabetic treatment and willing and able to safely discontinue that OAD therapy (for at least 6 weeks prior to the first dose of study treatment) and for the duration of the study.
- •5. On a documented, recommended diet and exercise program for at least 6 weeks prior to Visit 1 and willing to continue this program for the duration of the study.
- •6. Patients willing to follow the CGM procedures.
- •7. BMI of =40 kg/m2 at Visit 1
- •8.C-peptide laboratory value of =1.5 ng/mL (0.495 nmol/L) based on central laboratory results from Visit 1.
- •9. Female patients of childbearing potential, who are sexually active who agree to routinely use adequate contraception from Screening throughout the duration of the study.
- •Women must be one of the following:
- •a. Naturally postmenopausal defined as =1 year without menstruation and =55 years, or
- •b. <55 years with follicle-stimulating hormone (FSH) =40.0 IU/L, or
- •c. Surgically sterile including hysterectomy, bilateral oophorectomy, and/or tubal ligation, or
- •d. Women of childbearing potential willing to use an highly effective method of contraception during the study and for 30 days after the EoT including:
- •i. oral birth control medications.
- •ii. placement of an intrauterine device with or without hormones.
- •iii. vasectomized male partner who is the sole partner for this patient.
- •10. Male patients must be using 2 acceptable methods of contraception one of which must be a physical barrier method, (eg, spermicidal gel plus condom; condom plus partner is sterilized at least 6 months prior) for the entire study duration and for at least 10 days following the last study medication/placebo administration.
- •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 194
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 22
排除标准
- •1.Any known complication of T2DM indicating a late disease state
- •2.History of Type I diabetes, maturity onset diabetes of the young, secondary DM or known presence of glutamate decarboxylase 65 antibodies.
- •3.History of diabetic ketoacidosis, hyperosmolar non-ketotic coma, in the 6 months prior to Screening (Visit 1).
- •4.History of photo-hypersensitivity, porphyria, or hemochromatosis
- •5.Greater than 5% unexplained weight change (loss or gain) during the 3 months prior to enrolment
- •6.Fasting plasma glucose >270 mg/dL (>15 mmol/L) assessed based on central laboratory results from Visit 1 (can be repeated once during the Screening period)
- •7.Patients who take acetaminophen containing medications on a regular basis and are unable/unwilling to substitute it the day before placement of the sensor and throughout the 7-day CGM periods
- •8.History of bariatric surgery or lap-band surgery, or either procedure planned during the time period of the study. History of liposuction is allowed.
- •9.Patients with history of hypersensitivity to porphyrins and history of acute or chronic porphyria
- •10.History of any unstable endocrine, psychiatric, rapidly progressing or unstable renal disease, or rheumatic disorder
- •11.Patients who may be at risk for dehydration or volume depletion
- •12.Has evidence of current abuse of drugs or alcohol or a history of abuse within the past 52 weeks
- •13.Clinically significant cardiovascular disease or procedure within 3 months prior to enrolment or expected to require coronary revascularization procedure during the course of the study.
- •14.Severe uncontrolled arterial hypertension defined as systolic BP =180 mmHg and/or diastolic BP =110 mmHg at any visit up to and including the Randomization visit.
- •15.Presence or history of severe congestive heart failure (New York Heart Association Class III and IV).
- •16.Renal dysfunction with creatinine clearance <60 mL/min based on central laboratory results from Visit 1, or a diagnosed with nephrotic syndrome.
- •17.Familial renal glucosuria.
- •18.Significant hepatic disease, including, but not limited to, severe hepatic insufficiency and/or significant abnormal liver function defined as AST and/or ALT of >3 × upper limit of normal (ULN) based on central laboratory results from Visit 1.
- •19.Serum total bilirubin of >2.4 mg/dL (?41 mmol/L) (patients with documented Gilbert’s syndrome will be allowed to enroll) based on central laboratory results from Visit 1.
- •20.History of severe hepatobiliary disease or hepatotoxicity with any medication.
- •21.History or serologic evidence of infectious liver disease
- •22.Any history within 5 years of Visit 1 of any malignancy, with the exception of treated in situ basal cell or squamous cell carcinoma of the skin.
- •23.Hemoglobin (Hb) <10 g/dL (<100 g/L) or 6.2 mmol/L for men; Hb <9.0 g/dL (<90 g/L) or 5.9 mmol/L for women.
- •24.History of chronic hemolytic anemia or hemoglobinopathies
- •25.Donation or transfusion of blood, plasma, or platelets within the past 12 weeks prior to enrolment, or planning to donate blood during the study
- •26.In need of insulin treatment or having received insulin within 12 weeks before Visit 1 with the exception of short-term, acute insulin use for a period less than 7 days total
- •27.Administration of any other investigational product or participation in any interventional clinical studies 30 days prior to Visit 1 or 5 half-lives, whichever is longer
- •28.Treatment with systemic glucocorticoids equivalent to oral prednisolone =10 mg per day for >7 days w
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