Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
35 participants
INTERVENTIONAL
2012-05-31
2013-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
QUADRUPLE
Study Groups
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Placebo
Placebo
Supplement
5-aminolevulinic acid phosphate
Interventions
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Placebo
5-aminolevulinic acid phosphate
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
35 Years
70 Years
ALL
No
Sponsors
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SBI Pharmaceuticals Co, Ltd.
INDUSTRY
Hiroshima University
OTHER
Responsible Party
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Fumiko Higashikawa
Associate professor
Locations
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Hiroshima University
Hiroshima, , Japan
Countries
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Other Identifiers
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eki-541
Identifier Type: -
Identifier Source: org_study_id