Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Effects of 5-Aminolevulinic Acid on Glucose Metabolism

This study has been completed.
SBI Pharmaceuticals Co., Ltd., Japan
Information provided by (Responsible Party):
Fumiko Higashikawa, Hiroshima University Identifier:
First received: May 31, 2012
Last updated: December 17, 2013
Last verified: December 2013

This study is designed to evaluate efficacy of 5-aminolevulinic acid in subjects with type 2 diabetes on medication.

Condition Intervention
Type 2 Diabetes on Medication
Dietary Supplement: Placebo
Dietary Supplement: 5-aminolevulinic acid phosphate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized, Double-blind, Cross-over Study to Assess Efficacy of 5-Aminolevulinic Acid in Type 2 Diabetic Patients on Medication.

Resource links provided by NLM:

Further study details as provided by Hiroshima University:

Primary Outcome Measures:
  • Fasting glucose level [ Time Frame: Every 4 weeks (Overall 36 weeks) ] [ Designated as safety issue: No ]
  • HbA1c level [ Time Frame: Every 4 weeks (Overall 36 weeks) ] [ Designated as safety issue: No ]
  • Glycoalbumin level [ Time Frame: Every 4 weeks (Overall 36 weeks) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fasting insulin level [ Time Frame: Every 4 weeks (Overall 36 weeks) ] [ Designated as safety issue: No ]
  • 1,5-AG level [ Time Frame: Every 4 weeks (Overall 36 weeks) ] [ Designated as safety issue: No ]
  • Serum C-peptide level [ Time Frame: Every 4 weeks (Overall 36 weeks) ] [ Designated as safety issue: No ]
  • HOMA-R [ Time Frame: Every 4 weeks (Overall 36 weeks) ] [ Designated as safety issue: No ]

Estimated Enrollment: 35
Study Start Date: May 2012
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Dietary Supplement: Placebo
Experimental: Supplement Dietary Supplement: 5-aminolevulinic acid phosphate


Ages Eligible for Study:   35 Years to 70 Years
Genders Eligible for Study:   Both
Accepts 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01610778

Hiroshima University
Hiroshima, Japan, 7320814
Sponsors and Collaborators
Hiroshima University
SBI Pharmaceuticals Co., Ltd., Japan
  More Information

No publications provided

Responsible Party: Fumiko Higashikawa, Associate professor, Hiroshima University Identifier: NCT01610778     History of Changes
Other Study ID Numbers: eki-541
Study First Received: May 31, 2012
Last Updated: December 17, 2013
Health Authority: Japan: Institutional Review Board

Additional relevant MeSH terms:
Aminolevulinic Acid
Dermatologic Agents
Pharmacologic Actions
Photosensitizing Agents
Radiation-Sensitizing Agents
Therapeutic Uses processed this record on February 27, 2015