A 24-week, Phase IIa, Double blind, Randomized, Parallel Group, Placebo controlled, Exploratory Study to Evaluate the Efficacy and Safety of 5 Aminolevulinic Acid Co-administered with Sodium Ferrous Citrate Compared with Placebo in the Treatment of Adult Type 2 Diabetes Mellitus Patients who have not Achieved Adequate Glycaemic Control with Maximum Tolerated Dose of Metformin Daily or Sulfonylurea - Phase IIa Double-blind Exploratory Study of 5 ALA Co-administered with SFC in T2DM

neopharma Japan Co., Ltd0 个研究点目标入组 100 人开始时间: 2018年5月7日最近更新: 2020年4月6日

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: 100

研究概览入排标准研究者记录与标识符相似试验

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 =75) at time of informed consent, with a documented diagnosis of T2DM.
•2.Written and signed informed consent needs to be provided by patients who are legally capable before starting any protocol-specific procedures.
•3.HbA1c between 6.5% and 9% (both inclusive) based on central laboratory results from Visit 1, with individual need for therapy escalation (not to be re-assessed at Randomization Visit 3).
•4.Currently treated with a stable MTD of metformin (immediate-release and extended-release) therapy =1500 mg/day or a SU for at least 12 weeks prior to enrolment visit. The patient should remain on therapy with metformin or SU will remain on the same dose for the duration of the study for both treatment arms indicated.
•5.Patients willing to follow the CGM procedures.
•6.BMI of =40 kg/m2 at Visit 1.
•7.C-peptide laboratory value of =1.5 ng/mL (0.495 nmol/L) based on central laboratory results from Visit 1.
•8.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.
•9.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 90
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 10

排除标准

•1.Any known complication of T2DM indicating a late disease state
•2.History of Type 1 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 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 or 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 Visit 1 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 (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 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 (Hepatitis B viral antibody IgM, Hepatitis B virus surface antigen and Hepatitis C virus antibody)
•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 <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 anti hyperglycemic therapy, other than metformin or SU, during the 12 weeks prior to Visit 1. Exception for short-term insulin use (?7 days total) during the 9 weeks prior to Visit 1
•28.Administration of any other investi

研究者

发起方

neopharma Japan Co., Ltd

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