Type 2 Diabetes Mellitus MedDRA version: 20.0 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Product Name: 5- Aminolevulinic acid hydrochloride 150mg capsule
Pharmaceutical Form: Capsule
CAS Number: 5451-09-2
Current Sponsor code: 5-ALA hydrochloride, ALA hydrochloride,
Other descriptive name
Sponsors
neopharma Japan Co., Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female between 18 and 75 years old (age =65 years) yes F.1.3.1 Number of subjects for this age range 22
Exclusion criteria
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 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) 7 days w
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Achieving target HbA1c of 6.5% without significant hypoglycemia. •Occurrence of at least 1 episode of documented, symptomatic hypoglycemia during the 24-week Treatment period. •Occurrence of at least 1 severe hypoglycemic event (2017 American Diabetes Association [ADA] classification) during the 24-week Treatment period. •Occurrence of at least 1 episode of documented, symptomatic hypoglycemia during the 24-week Treatment period, in the age groups below 65 years and 65 years and older (18 to 64 years; 65 to 75 years). •Achieving HbA1c of =7% and =6.5% without documented, symptomatic hypoglycemia at Week 24. •Achieving HbA1c of =7% and =6.5% at Week 24. •Achieving an HbA1c decrease of =1% with no weight gain at Week 24. •Time spent at or below HbA1c target (=7% and =6.5%) during the 24-week Treatment period. •Change in fructosamine levels between Baseline and Week 24. •Change in fructosamine levels at 2 weekly intervals from Baseline until end of study. •Change in Hb, total bilirubin and serum ferritin over the 24-week Treatment period. •Change in body mass index (BMI) from Baseline to Week 24. •Change in waist circumference from Baseline to Week 24. •Achieving weight reduction of =5% or weight gain of =5% from Baseline to Week 24. •Change in BP from Baseline to Week 24. •Requiring rescue therapy for lack of glycemic control. •Change in average CGM measured blood glucose (CGMG) from Baseline to Week 12 and Week 24. •Percent (%) of time in different CGM glucose ranges. •Further CGM parameters (Area under curve [AUC], variability parameters). •Change from Baseline in patient-reported outcomes (PROs) at Week 24. Safety endpoints: • Proportion of patients withdrawing from study due to hypoglycemia. • AEs/ serious adverse events (SAEs). • Adverse events of special interest. • Clinical laboratory tests. • ECG. • Vital signs (pulse and BP). • Body temperature. • Hypoglycemic events. • SMGB. • Physical examinations. ;Timepoint(s) of evaluation of t | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the change from Baseline in Glycated hemoglobin (HbA1c) up to Week 24 between each dose combination of 5 aminolevulinic acid/sodium ferrous citrate (5 ALA/SFC) and placebo.;Secondary Objective: • To compare the occurrence of documented hypoglycemic episodes during the 24-week Treatment period between the 2- treatment arms. • To compare the change from Baseline in total body weight at Week 24 between the 2 treatment arms. • To evaluate fructosamine as an alternative biomarker for glycemic control. • To explore glucose patterns of 5 ALA/SFC over the 24-hour period during 7 days at Baseline, Week 12 and Week 24, as captured through continuous Glucose Monitoring (CGM). • To compare the need for rescue therapy of each dose combination of 5-ALA/SFC with placebo. • To compare additional effects (blood pressure [BP], temperature) of 5-ALA/SFC with placebo at Week 24. • To explore the change from Baseline in laboratory assessments of interest Safety: To evaluate safety and tolerability of 5-ALA/SFC (adverse events [AEs], safety laboratory tests, Self-monitoring of blood glucose [SMBG], and electrocardiogram [ECG]).;Primary end point(s): Mean change from Baseline in HbA1c to Week 24. ;Timepoint(s) of evaluation of this end point: This endpoint will be evaluated at sreening, at week -2, week 0, 4, 8, 12, 20 and 24. | — |
Countries
Estonia, Hungary, Poland, Romania, Ukraine
Contacts
Public ContactClinical Trial Information Desk
neopharma Japan Co., Ltd.
Outcome results
None listed