Trial Outcomes & Findings for Pilot Study to Evaluate the Safety and Efficacy of 5-ALA-SFC in Type II Diabetes (NCT NCT02481141)

Last Updated: 2018-05-22

Results Overview

The objective of the current study was to investigate the safety and preliminary efficacy of doses up to 200 mg 5-ALA - SFC in a population of patients with type 2 diabetes mellitus living in Bahrain.

Recruitment status

COMPLETED

Study phase

Target enrollment

53 participants

Primary outcome timeframe

Week 2, Week 4, Week 12

Results posted on

2018-05-22

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	35	18
Overall Study COMPLETED	26	13
Overall Study NOT COMPLETED	9	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	5-ALA-SFC n=35 Participants 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 n=15 Participants 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 n=50 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	33 Participants n=99 Participants	15 Participants n=107 Participants	48 Participants n=206 Participants
Age, Categorical >=65 years	2 Participants n=99 Participants	0 Participants n=107 Participants	2 Participants n=206 Participants
Age, Continuous	52.4 years STANDARD_DEVIATION 6.51 • n=99 Participants	51.9 years STANDARD_DEVIATION 5.07 • n=107 Participants	52.2 years STANDARD_DEVIATION 6.07 • n=206 Participants
Sex: Female, Male Female	2 Participants n=99 Participants	2 Participants n=107 Participants	4 Participants n=206 Participants
Sex: Female, Male Male	33 Participants n=99 Participants	13 Participants n=107 Participants	46 Participants n=206 Participants
Region of Enrollment Bahrain	35 participants n=99 Participants	15 participants n=107 Participants	50 participants n=206 Participants

PRIMARY outcome

Timeframe: Week 2, Week 4, Week 12

Population: Safety population included all subjects who took at least one dose of study product.

Outcome measures

Outcome measures
Measure	5-ALA-SFC Through Week 2 (50 mg 2x/Day) n=35 Participants Study product administration will be as follows: Beginning Week 0: 1 capsule of 50mg 5-ALA-SFC twice per day for 2 weeks	5-ALA-SFC Through Week 4 (75 mg 2x/Day) n=35 Participants Study product administration will be as follows: Beginning Week 2: 1 capsule of 75mg 5-ALA-SFC twice per day for 2 weeks	5-ALA-SFC Through Week 12 (100 mg 2x/Day) n=35 Participants Study product administration will be as follows: Beginning Week 2: 1 capsule of 75mg 5-ALA-SFC twice per day for 2 weeks	Placebo Through Week 2 n=18 Participants Study matching placebo administration will be as follows: Beginning Week 0: 1 capsule twice per day for 2 weeks	Placebo Through Week 4 n=18 Participants Study matching placebo administration will be as follows: Beginning Week 2: 1 capsule twice per day for 2 weeks	Placebo Through Week 12 n=18 Participants Study matching placebo administration will be as follows: Beginning Week 4: 1 capsule twice per day for 8 weeks
Subjects With Adverse Events as a Measure of Safety and Tolerability	6 Participants	8 Participants	2 Participants	3 Participants	1 Participants	1 Participants

PRIMARY outcome

Timeframe: Baseline, Week 2, Week 4, Week 12

Population: Intent-to-Treat Population (ITT) included all subjects who took at least one dose of study product and had at least one post-baseline efficacy evaluation. Change from Baseline was calculated as the mean for the visit compared to baseline mean for only the subjects with a result for that visit.

Outcome measures

Outcome measures
Measure	5-ALA-SFC Through Week 2 (50 mg 2x/Day) n=33 Participants Study product administration will be as follows: Beginning Week 0: 1 capsule of 50mg 5-ALA-SFC twice per day for 2 weeks	5-ALA-SFC Through Week 4 (75 mg 2x/Day) n=30 Participants Study product administration will be as follows: Beginning Week 2: 1 capsule of 75mg 5-ALA-SFC twice per day for 2 weeks	5-ALA-SFC Through Week 12 (100 mg 2x/Day) n=22 Participants Study product administration will be as follows: Beginning Week 2: 1 capsule of 75mg 5-ALA-SFC twice per day for 2 weeks	Placebo Through Week 2 n=14 Participants Study matching placebo administration will be as follows: Beginning Week 0: 1 capsule twice per day for 2 weeks	Placebo Through Week 4 n=14 Participants Study matching placebo administration will be as follows: Beginning Week 2: 1 capsule twice per day for 2 weeks	Placebo Through Week 12 n=12 Participants Study matching placebo administration will be as follows: Beginning Week 4: 1 capsule twice per day for 8 weeks
Change From Baseline in Fasting Blood Glucose	2.3 mg/dL Standard Error 3.4	-0.2 mg/dL Standard Error 4.9	-3.0 mg/dL Standard Error 4.4	-7.3 mg/dL Standard Error 5.2	-0.8 mg/dL Standard Error 7.2	-4.2 mg/dL Standard Error 5.9

SECONDARY outcome

Timeframe: Baseline, Week 2, Week 4, Week 12

Change from baseline in blood glucose levels 2 hours after breakfast

Outcome measures

Outcome measures
Measure	5-ALA-SFC Through Week 2 (50 mg 2x/Day) n=33 Participants Study product administration will be as follows: Beginning Week 0: 1 capsule of 50mg 5-ALA-SFC twice per day for 2 weeks	5-ALA-SFC Through Week 4 (75 mg 2x/Day) n=30 Participants Study product administration will be as follows: Beginning Week 2: 1 capsule of 75mg 5-ALA-SFC twice per day for 2 weeks	5-ALA-SFC Through Week 12 (100 mg 2x/Day) n=21 Participants Study product administration will be as follows: Beginning Week 2: 1 capsule of 75mg 5-ALA-SFC twice per day for 2 weeks	Placebo Through Week 2 n=14 Participants Study matching placebo administration will be as follows: Beginning Week 0: 1 capsule twice per day for 2 weeks	Placebo Through Week 4 n=12 Participants Study matching placebo administration will be as follows: Beginning Week 2: 1 capsule twice per day for 2 weeks	Placebo Through Week 12 n=10 Participants Study matching placebo administration will be as follows: Beginning Week 4: 1 capsule twice per day for 8 weeks
Change From Baseline in 2 Hour Post Meal Glucose Level	-0.2 mg/dL Standard Error 5.1	-12.9 mg/dL Standard Error 6.1	-8.5 mg/dL Standard Error 9.8	-26.5 mg/dL Standard Error 7.8	-18.8 mg/dL Standard Error 9.9	-33.0 mg/dL Standard Error 14.2

SECONDARY outcome

Timeframe: Baseline, Week 6, Week 12

Change from baseline measured at week 6 and week 12 only

Outcome measures

Outcome measures
Measure	5-ALA-SFC Through Week 2 (50 mg 2x/Day) n=30 Participants Study product administration will be as follows: Beginning Week 0: 1 capsule of 50mg 5-ALA-SFC twice per day for 2 weeks	5-ALA-SFC Through Week 4 (75 mg 2x/Day) n=26 Participants Study product administration will be as follows: Beginning Week 2: 1 capsule of 75mg 5-ALA-SFC twice per day for 2 weeks	5-ALA-SFC Through Week 12 (100 mg 2x/Day) n=13 Participants Study product administration will be as follows: Beginning Week 2: 1 capsule of 75mg 5-ALA-SFC twice per day for 2 weeks	Placebo Through Week 2 n=13 Participants Study matching placebo administration will be as follows: Beginning Week 0: 1 capsule twice per day for 2 weeks	Placebo Through Week 4 Study matching placebo administration will be as follows: Beginning Week 2: 1 capsule twice per day for 2 weeks	Placebo Through Week 12 Study matching placebo administration will be as follows: Beginning Week 4: 1 capsule twice per day for 8 weeks
Change From Baseline in Body Weight	-0.1 kg Standard Error 0.5	-0.2 kg Standard Error 0.3	-0.3 kg Standard Error 0.7	-0.8 kg Standard Error 0.4	—	—

SECONDARY outcome

Timeframe: Baseline, Week 2, Week 4, Week 12

Change from baseline in HbA1c %

Outcome measures

Outcome measures
Measure	5-ALA-SFC Through Week 2 (50 mg 2x/Day) n=32 Participants Study product administration will be as follows: Beginning Week 0: 1 capsule of 50mg 5-ALA-SFC twice per day for 2 weeks	5-ALA-SFC Through Week 4 (75 mg 2x/Day) n=30 Participants Study product administration will be as follows: Beginning Week 2: 1 capsule of 75mg 5-ALA-SFC twice per day for 2 weeks	5-ALA-SFC Through Week 12 (100 mg 2x/Day) n=25 Participants Study product administration will be as follows: Beginning Week 2: 1 capsule of 75mg 5-ALA-SFC twice per day for 2 weeks	Placebo Through Week 2 n=13 Participants Study matching placebo administration will be as follows: Beginning Week 0: 1 capsule twice per day for 2 weeks	Placebo Through Week 4 n=13 Participants Study matching placebo administration will be as follows: Beginning Week 2: 1 capsule twice per day for 2 weeks	Placebo Through Week 12 n=13 Participants Study matching placebo administration will be as follows: Beginning Week 4: 1 capsule twice per day for 8 weeks
Change From Baseline in HbA1c	-0.2 percentage of HbA1c Standard Error 0.1	-0.3 percentage of HbA1c Standard Error 0.1	-0.7 percentage of HbA1c Standard Error 0.2	-0.5 percentage of HbA1c Standard Error 0.2	-0.5 percentage of HbA1c Standard Error 0.2	-0.5 percentage of HbA1c Standard Error 0.2

SECONDARY outcome

Timeframe: Baseline, Week 6, Week 12

Change from baseline measured at week 6 and week 12 only

Outcome measures

Outcome measures
Measure	5-ALA-SFC Through Week 2 (50 mg 2x/Day) n=27 Participants Study product administration will be as follows: Beginning Week 0: 1 capsule of 50mg 5-ALA-SFC twice per day for 2 weeks	5-ALA-SFC Through Week 4 (75 mg 2x/Day) n=25 Participants Study product administration will be as follows: Beginning Week 2: 1 capsule of 75mg 5-ALA-SFC twice per day for 2 weeks	5-ALA-SFC Through Week 12 (100 mg 2x/Day) n=13 Participants Study product administration will be as follows: Beginning Week 2: 1 capsule of 75mg 5-ALA-SFC twice per day for 2 weeks	Placebo Through Week 2 n=13 Participants Study matching placebo administration will be as follows: Beginning Week 0: 1 capsule twice per day for 2 weeks	Placebo Through Week 4 Study matching placebo administration will be as follows: Beginning Week 2: 1 capsule twice per day for 2 weeks	Placebo Through Week 12 Study matching placebo administration will be as follows: Beginning Week 4: 1 capsule twice per day for 8 weeks
Change From Baseline in Total Cholesterol (Component of Lipid Profile)	-5.2 mg/dL Standard Error 3.7	6.8 mg/dL Standard Error 3.5	-7.6 mg/dL Standard Error 5.5	-0.1 mg/dL Standard Error 5.0	—	—

SECONDARY outcome

Timeframe: Baseline, Week 6, Week 12

Change from baseline measured at week 6 and week 12 only

Outcome measures

Outcome measures
Measure	5-ALA-SFC Through Week 2 (50 mg 2x/Day) n=27 Participants Study product administration will be as follows: Beginning Week 0: 1 capsule of 50mg 5-ALA-SFC twice per day for 2 weeks	5-ALA-SFC Through Week 4 (75 mg 2x/Day) n=25 Participants Study product administration will be as follows: Beginning Week 2: 1 capsule of 75mg 5-ALA-SFC twice per day for 2 weeks	5-ALA-SFC Through Week 12 (100 mg 2x/Day) n=13 Participants Study product administration will be as follows: Beginning Week 2: 1 capsule of 75mg 5-ALA-SFC twice per day for 2 weeks	Placebo Through Week 2 n=13 Participants Study matching placebo administration will be as follows: Beginning Week 0: 1 capsule twice per day for 2 weeks	Placebo Through Week 4 Study matching placebo administration will be as follows: Beginning Week 2: 1 capsule twice per day for 2 weeks	Placebo Through Week 12 Study matching placebo administration will be as follows: Beginning Week 4: 1 capsule twice per day for 8 weeks
Change From Baseline LDL (Component of Lipid Profile)	-2.9 mg/dL Standard Error 3.2	7.6 mg/dL Standard Error 3.3	-11.8 mg/dL Standard Error 4.7	-4.0 mg/dL Standard Error 4.6	—	—

SECONDARY outcome

Timeframe: Baseline, Week 6, Week 12

Change from baseline measured at week 6 and week 12 only

Outcome measures

Outcome measures
Measure	5-ALA-SFC Through Week 2 (50 mg 2x/Day) n=27 Participants Study product administration will be as follows: Beginning Week 0: 1 capsule of 50mg 5-ALA-SFC twice per day for 2 weeks	5-ALA-SFC Through Week 4 (75 mg 2x/Day) n=25 Participants Study product administration will be as follows: Beginning Week 2: 1 capsule of 75mg 5-ALA-SFC twice per day for 2 weeks	5-ALA-SFC Through Week 12 (100 mg 2x/Day) n=13 Participants Study product administration will be as follows: Beginning Week 2: 1 capsule of 75mg 5-ALA-SFC twice per day for 2 weeks	Placebo Through Week 2 n=13 Participants Study matching placebo administration will be as follows: Beginning Week 0: 1 capsule twice per day for 2 weeks	Placebo Through Week 4 Study matching placebo administration will be as follows: Beginning Week 2: 1 capsule twice per day for 2 weeks	Placebo Through Week 12 Study matching placebo administration will be as follows: Beginning Week 4: 1 capsule twice per day for 8 weeks
Change From Baseline in HDL (Component of Lipid Profile)	-0.8 mg/dL Standard Error 1.0	0.5 mg/dL Standard Error 1.0	-1.6 mg/dL Standard Error 1.4	-1.1 mg/dL Standard Error 1.4	—	—

SECONDARY outcome

Timeframe: Baseline, Week 6, Week 12

Change from baseline measured at week 6 and week 12 only

Outcome measures

Outcome measures
Measure	5-ALA-SFC Through Week 2 (50 mg 2x/Day) n=27 Participants Study product administration will be as follows: Beginning Week 0: 1 capsule of 50mg 5-ALA-SFC twice per day for 2 weeks	5-ALA-SFC Through Week 4 (75 mg 2x/Day) n=25 Participants Study product administration will be as follows: Beginning Week 2: 1 capsule of 75mg 5-ALA-SFC twice per day for 2 weeks	5-ALA-SFC Through Week 12 (100 mg 2x/Day) n=13 Participants Study product administration will be as follows: Beginning Week 2: 1 capsule of 75mg 5-ALA-SFC twice per day for 2 weeks	Placebo Through Week 2 n=13 Participants Study matching placebo administration will be as follows: Beginning Week 0: 1 capsule twice per day for 2 weeks	Placebo Through Week 4 Study matching placebo administration will be as follows: Beginning Week 2: 1 capsule twice per day for 2 weeks	Placebo Through Week 12 Study matching placebo administration will be as follows: Beginning Week 4: 1 capsule twice per day for 8 weeks
Change From Baseline in Triglycerides (Component of Lipid Profile)	-1.3 mg/dL Standard Error 14.6	3.2 mg/dL Standard Error 11.1	4.5 mg/dL Standard Error 21.1	11.9 mg/dL Standard Error 15.4	—	—

Adverse Events

5-ALA-SFC Through Week 2

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

5-ALA-SFC Through Week 4

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

5-ALA-SFC Through Week 12

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Placebo Through Week 2

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo Through Week 4

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Placebo Through Week 12

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	5-ALA-SFC Through Week 2 n=35 participants at risk Beginning Week 0: 1 capsule of 50mg 5-ALA-SFC twice per day for 2 weeks	5-ALA-SFC Through Week 4 n=35 participants at risk Beginning Week 2: 1 capsule of 75mg 5-ALA-SFC twice per day for 2 weeks	5-ALA-SFC Through Week 12 n=35 participants at risk Beginning Week 4: 1 capsule of 100mg 5-ALA-SFC twice per day for 8 weeks	Placebo Through Week 2 n=18 participants at risk Beginning Week 0: 1 placebo capsule twice per day for 2 weeks	Placebo Through Week 4 n=18 participants at risk Beginning Week 2: 1 placebo capsule twice per day for 2 weeks	Placebo Through Week 12 n=18 participants at risk Beginning Week 4: 1 placebo capsule twice per day for 8 weeks
Infections and infestations Abscess in the nose	2.9% 1/35 • Number of events 1 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	0.00% 0/35 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	0.00% 0/35 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	0.00% 0/18 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	0.00% 0/18 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	0.00% 0/18 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.

Other adverse events

Other adverse events
Measure	5-ALA-SFC Through Week 2 n=35 participants at risk Beginning Week 0: 1 capsule of 50mg 5-ALA-SFC twice per day for 2 weeks	5-ALA-SFC Through Week 4 n=35 participants at risk Beginning Week 2: 1 capsule of 75mg 5-ALA-SFC twice per day for 2 weeks	5-ALA-SFC Through Week 12 n=35 participants at risk Beginning Week 4: 1 capsule of 100mg 5-ALA-SFC twice per day for 8 weeks	Placebo Through Week 2 n=18 participants at risk Beginning Week 0: 1 placebo capsule twice per day for 2 weeks	Placebo Through Week 4 n=18 participants at risk Beginning Week 2: 1 placebo capsule twice per day for 2 weeks	Placebo Through Week 12 n=18 participants at risk Beginning Week 4: 1 placebo capsule twice per day for 8 weeks
Cardiac disorders Palpitations	0.00% 0/35 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	0.00% 0/35 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	2.9% 1/35 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	0.00% 0/18 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	0.00% 0/18 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	0.00% 0/18 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.
Gastrointestinal disorders Abdominal Distension	0.00% 0/35 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	2.9% 1/35 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	2.9% 1/35 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	0.00% 0/18 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	0.00% 0/18 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	0.00% 0/18 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.
Gastrointestinal disorders Abdominal pain upper	2.9% 1/35 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	5.7% 2/35 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	5.7% 2/35 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	0.00% 0/18 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	0.00% 0/18 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	0.00% 0/18 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.
Gastrointestinal disorders Constipation	0.00% 0/35 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	2.9% 1/35 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	2.9% 1/35 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	0.00% 0/18 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	0.00% 0/18 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	0.00% 0/18 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.
Gastrointestinal disorders Diarrhoea	5.7% 2/35 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	5.7% 2/35 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	5.7% 2/35 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	0.00% 0/18 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	5.6% 1/18 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	11.1% 2/18 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.
Gastrointestinal disorders Dyspepsia	2.9% 1/35 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	2.9% 1/35 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	2.9% 1/35 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	0.00% 0/18 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	0.00% 0/18 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	5.6% 1/18 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.
Gastrointestinal disorders Faeces discoloured	0.00% 0/35 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	2.9% 1/35 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	2.9% 1/35 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	0.00% 0/18 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	0.00% 0/18 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	0.00% 0/18 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.
Gastrointestinal disorders Faeces hard	0.00% 0/35 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	2.9% 1/35 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	2.9% 1/35 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	0.00% 0/18 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	0.00% 0/18 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	0.00% 0/18 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.
Gastrointestinal disorders Gastrointestinal disorder	0.00% 0/35 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	0.00% 0/35 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	2.9% 1/35 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	0.00% 0/18 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	0.00% 0/18 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	0.00% 0/18 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.
Gastrointestinal disorders Nausea	0.00% 0/35 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	2.9% 1/35 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	2.9% 1/35 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	0.00% 0/18 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	0.00% 0/18 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	0.00% 0/18 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.
General disorders Fatigue	0.00% 0/35 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	2.9% 1/35 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	2.9% 1/35 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	0.00% 0/18 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	0.00% 0/18 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	0.00% 0/18 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.
General disorders Pyrexia	0.00% 0/35 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	2.9% 1/35 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	2.9% 1/35 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	0.00% 0/18 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	0.00% 0/18 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	0.00% 0/18 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.
Investigations Blood Glucose Increased	0.00% 0/35 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	0.00% 0/35 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	2.9% 1/35 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	0.00% 0/18 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	0.00% 0/18 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	0.00% 0/18 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/35 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	2.9% 1/35 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	2.9% 1/35 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	0.00% 0/18 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	0.00% 0/18 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	0.00% 0/18 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/35 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	0.00% 0/35 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	2.9% 1/35 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	5.6% 1/18 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	5.6% 1/18 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	5.6% 1/18 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/35 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	0.00% 0/35 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	0.00% 0/35 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	0.00% 0/18 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	0.00% 0/18 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	5.6% 1/18 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/35 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	0.00% 0/35 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	0.00% 0/35 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	5.6% 1/18 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	5.6% 1/18 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	5.6% 1/18 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.
Nervous system disorders Headache	0.00% 0/35 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	2.9% 1/35 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	5.7% 2/35 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	5.6% 1/18 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	5.6% 1/18 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	5.6% 1/18 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.
Reproductive system and breast disorders Erectile dysfunction	0.00% 0/35 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	0.00% 0/35 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	2.9% 1/35 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	0.00% 0/18 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	0.00% 0/18 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	0.00% 0/18 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.
Respiratory, thoracic and mediastinal disorders Cough	2.9% 1/35 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	5.7% 2/35 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	5.7% 2/35 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	0.00% 0/18 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	0.00% 0/18 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	0.00% 0/18 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.
Respiratory, thoracic and mediastinal disorders Nasal congestion	2.9% 1/35 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	2.9% 1/35 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	2.9% 1/35 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	0.00% 0/18 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	0.00% 0/18 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	0.00% 0/18 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/35 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	2.9% 1/35 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	2.9% 1/35 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	0.00% 0/18 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	0.00% 0/18 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.	0.00% 0/18 • All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.

Additional Information

Dr. Riyadh Rehani, President of MENA Region

SBI Pharmaceuticals Co, Ltd.

Phone: +973 66394100

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place