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Pilot Study to Evaluate the Safety and Efficacy of 5-ALA-SFC in Type II Diabetes

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ClinicalTrials.gov Identifier: NCT02481141
Recruitment Status : Completed
First Posted : June 25, 2015
Results First Posted : December 11, 2017
Last Update Posted : May 22, 2018
Sponsor:
Information provided by (Responsible Party):
SBI Pharmaceuticals Co, Ltd.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type 2
Interventions: Drug: 5-ALA-SFC
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
5-ALA-SFC

Study product administration will be as follows:

Beginning Week 0: 1 capsule of 50mg 5-ALA-SFC twice per day for 2 weeks Beginning Week 2: 1 capsule of 75mg 5-ALA-SFC twice per day for 2 weeks Beginning Week 4: 1 capsule of 100mg 5-ALA-SFC twice per day for 8 weeks

5-ALA-SFC: Study product will be in the form of white-opaque capsules for oral administration, containing either 50, 75, or 100 mg of active 5-ALA – SFC

Placebo

Study matching placebo administration will be as follows:

Beginning Week 0: 1 capsule twice per day for 2 weeks Beginning Week 2: 1 capsule twice per day for 2 weeks Beginning Week 4: 1 capsule twice per day for 8 weeks

Placebo


Participant Flow:   Overall Study
    5-ALA-SFC   Placebo
STARTED   35   18 
COMPLETED   26   13 
NOT COMPLETED   9   5 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent-to-Treat Population (ITT) included all patients who took at least one dose of study product and had at least one post-baseline efficacy evaluation

Reporting Groups
  Description
5-ALA-SFC

Study product administration will be as follows:

Beginning Week 0: 1 capsule of 50mg 5-ALA-SFC twice per day for 2 weeks Beginning Week 2: 1 capsule of 75mg 5-ALA-SFC twice per day for 2 weeks Beginning Week 4: 1 capsule of 100mg 5-ALA-SFC twice per day for 8 weeks

5-ALA-SFC: Study product will be in the form of white-opaque capsules for oral administration, containing either 50, 75, or 100 mg of active 5-ALA – SFC

Placebo

Study matching placebo administration will be as follows:

Beginning Week 0: 1 capsule twice per day for 2 weeks Beginning Week 2: 1 capsule twice per day for 2 weeks Beginning Week 4: 1 capsule twice per day for 8 weeks

Placebo

Total Total of all reporting groups

Baseline Measures
   5-ALA-SFC   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 35   15   50 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      33  94.3%      15 100.0%      48  96.0% 
>=65 years      2   5.7%      0   0.0%      2   4.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 52.4  (6.51)   51.9  (5.07)   52.2  (6.07) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      2   5.7%      2  13.3%      4   8.0% 
Male      33  94.3%      13  86.7%      46  92.0% 
Region of Enrollment 
[Units: Participants]
     
Bahrain   35   15   50 


  Outcome Measures

1.  Primary:   Subjects With Adverse Events as a Measure of Safety and Tolerability   [ Time Frame: Week 2, Week 4, Week 12 ]

2.  Primary:   Change From Baseline in Fasting Blood Glucose   [ Time Frame: Baseline, Week 2, Week 4, Week 12 ]

3.  Secondary:   Change From Baseline in 2 Hour Post Meal Glucose Level   [ Time Frame: Baseline, Week 2, Week 4, Week 12 ]

4.  Secondary:   Change From Baseline in Body Weight   [ Time Frame: Baseline, Week 6, Week 12 ]

5.  Secondary:   Change From Baseline in HbA1c   [ Time Frame: Baseline, Week 2, Week 4, Week 12 ]

6.  Secondary:   Change From Baseline in Total Cholesterol (Component of Lipid Profile)   [ Time Frame: Baseline, Week 6, Week 12 ]

7.  Secondary:   Change From Baseline LDL (Component of Lipid Profile)   [ Time Frame: Baseline, Week 6, Week 12 ]

8.  Secondary:   Change From Baseline in HDL (Component of Lipid Profile)   [ Time Frame: Baseline, Week 6, Week 12 ]

9.  Secondary:   Change From Baseline in Triglycerides (Component of Lipid Profile)   [ Time Frame: Baseline, Week 6, Week 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Riyadh Rehani, President of MENA Region
Organization: SBI Pharmaceuticals Co, Ltd.
phone: +973 66394100
e-mail: rrehani@sbigroup.co.jp


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: SBI Pharmaceuticals Co, Ltd.
ClinicalTrials.gov Identifier: NCT02481141     History of Changes
Other Study ID Numbers: SBIP12-002F
First Submitted: June 17, 2015
First Posted: June 25, 2015
Results First Submitted: November 3, 2016
Results First Posted: December 11, 2017
Last Update Posted: May 22, 2018