Type 2 Diabetes on Medication
Conditions
Brief summary
This study is designed to evaluate efficacy of 5-aminolevulinic acid in subjects with type 2 diabetes on medication.
Interventions
DIETARY_SUPPLEMENTPlacebo
DIETARY_SUPPLEMENT5-aminolevulinic acid phosphate
Sponsors
SBI Pharmaceuticals Co, Ltd.
Hiroshima University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Type 2 diabetic patients on medication * HbA1c ≤ 9.0% (as JDS values, which is equivalent to HbA1c ≤ 9.4% as NGSP values) * On stable treatment of diabetes for at least the last 3 months * With permission to attend the clinical trial from the primary doctor
Exclusion criteria
* On insulin therapy * BMI ≤ 18 kg/m2 or ≥ 30 kg/m2 * History of porphyria, hemochromatosis, or viral hepatitis * Pregnant or nursing a child * Heart disease * Renal or hepatic dysfunction * Participation in any clinical trial within 90 days of the commencement of the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fasting glucose level | Every 4 weeks (Overall 36 weeks) |
| HbA1c level | Every 4 weeks (Overall 36 weeks) |
| Glycoalbumin level | Every 4 weeks (Overall 36 weeks) |
Secondary
| Measure | Time frame |
|---|---|
| Fasting insulin level | Every 4 weeks (Overall 36 weeks) |
| HOMA-R | Every 4 weeks (Overall 36 weeks) |
| 1,5-AG level | Every 4 weeks (Overall 36 weeks) |
| Serum C-peptide level | Every 4 weeks (Overall 36 weeks) |
Countries
Japan
Outcome results
None listed