Effects of 5-Aminolevulinic Acid on Glucose Metabolism

Type 2 Diabetes on Medication Clinical Trial

Official title:

A Randomized, Double-blind, Cross-over Study to Assess Efficacy of 5-Aminolevulinic Acid in Type 2 Diabetic Patients on Medication.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01610778
• Other study ID #: eki-541
• Status: Completed
• Phase: N/A
• First received: May 31, 2012
• Last updated: December 17, 2013
• Start date: May 2012
• Est. completion date: September 2013

Study information

• Verified date: December 2013
• Source: Hiroshima University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Type 2 Diabetes on Medication

Intervention

Dietary Supplement:
• Placebo

• 5-aminolevulinic acid phosphate

Locations

Country	Name	City	State
Japan	Hiroshima University	Hiroshima

Sponsors (2)

Lead Sponsor	Collaborator
Hiroshima University	SBI Pharmaceuticals Co, Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting glucose level		Every 4 weeks (Overall 36 weeks)	No
Primary	HbA1c level		Every 4 weeks (Overall 36 weeks)	No
Primary	Glycoalbumin level		Every 4 weeks (Overall 36 weeks)	No
Secondary	Fasting insulin level		Every 4 weeks (Overall 36 weeks)	No
Secondary	1,5-AG level		Every 4 weeks (Overall 36 weeks)	No
Secondary	Serum C-peptide level		Every 4 weeks (Overall 36 weeks)	No
Secondary	HOMA-R		Every 4 weeks (Overall 36 weeks)	No