Diabetes mellitus
Conditions
Interventions
First group: test food (5-ALA Amg)
Second group: test food (5-ALA Bmg)
Third group: placebo food (5-ALA 0mg)
Sponsors
SBI Pharmaceuticals Co., Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Man or woman whose age is from 30 to 75 when the informed consent is obtained. 2. Diabetic patient taking more than one of the following drugs ;sulfonylurea, thiazolidine-derivative, DPP-4 inhibitor, or metformin. 3. No history of hypoglycemic attack for 3 months before entry and supposed no change of anti-diabetic drugs during the clinical study
Exclusion criteria
Exclusion criteria: 1. A patient injecting insulin. 2. Severe disease condition (renal disease, liver disease, heart disease etc). 3. A patient who is taking the following drug; anti-convulsant, antiarrhythmic agent, or coronary vasodilator. 4. A woman who is pregnant or may be pregnat, or who is lactating. 5. A patient who is enrolled in another clinical trial, or who had been enrolled in another clinical trial within the past 3 months. 6. A patient allergic for medical drug and food. 7. Uncontrolled alcoholism or severe mental disorder. 8. A patient who is judged by the doctor as not eligible to this study. etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and occurrence of hypoglycemic attack | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd. Division of Clinical Study
Outcome results
None listed