A blind study to evaluate the efficacy and safety of two different Doses of 5 Aminolevulinic Acid Co-administered with Sodium Ferrous Citrate (study drugs) compared with placebo in the treatment of Type 2 Diabetes Mellitus Patients

Phase 1

• Conditions: Type 2 Diabetes Mellitus; MedDRA version: 20.0Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

• Registration Number: EUCTR2017-004944-39-HU
• Lead Sponsor: neopharma Japan Co., Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-05-07
• Last Update Posted: 13 October 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 216

Inclusion Criteria

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.
3. HbA1c
• 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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified