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

A study testing 5-ALA-SFC in people with Diabetes Mellitus, Type 2, run by SBI Pharmaceuticals Co, Ltd..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The aim of this pilot study is to assess the safety and preliminary efficacy of 5-ALA - SFC at doses up to 200 mg per day in subjects with type II diabetes. Read more about this study

Who is it for?: Ages 20 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: 5-ALA-SFC
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 53 participants
Where: No sites listed yet
Study dates: Jul 2014to Jul 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Males and females residing in Bahrain aged 20 to 75 years old
Otherwise in good health in the opinion of the investigator based on results of medical history, physical exam and laboratory assessments
Diagnosed with type II diabetes mellitus with HbA1c >6.5 and <10% which is uncontrolled despite the use of one or more glycemia-lowering drugs
BMI ≤44 kg/m2
Sitting BP ≤ 160/100mm Hg
Sleep apnea screening is negative
Ophthalmological exam is within normal limits as judged by the investigator. If findings are observed, they must be judged as not clinically significant.
Female subjects are not pregnant, not breast-feeding, and if of childbearing potential, have agreed to use an acceptable method of birth control

Who cannot join

Liver dysfunction defined as liver function tests >1.5 times upper limit of normal
Renal dysfunction defined as BUN and/or serum creatinine >1.5 times upper limit of normal and/or eGFR <30 ml/min/1.73 m2
History of any life-threatening disease, cardiovascular disease, viral hepatitis, porphyria or hemochromatosis
Allergy to ALA, SFC, or any other component of study product
Use of insulin for management of serum glucose
Hypoglycemic event within the previous 3 months, defined as serum glucose levels less than 70 mg/dL
History of sickle cell anemia disease

About this study

Official title: Prospective, Randomized, Single-Blind, Placebo-Controlled, Dose-Escalation Pilot Study to Evaluate the Safety and Efficacy of 5-ALA-SFC in Subjects With Type II Diabetes

The aim of this pilot study is to assess the safety and preliminary efficacy of 5-ALA - SFC at doses up to 200 mg per day in subjects with type II diabetes.

Read the detailed description

The primary objective is to assess the safety of 5-ALA - SFC at doses up to 200 mg per day in subjects with type II diabetes mellitus. Safety will be assessed by the incidence of adverse events and clinically significant laboratory results.

The secondary objective is to assess the efficacy of 5-ALA-SFC at doses up to 200 mg per day on glycemic control in subjects with type II diabetes mellitus. Efficacy measures will include fasting plasma glucose level, HbA1c level, lipid profile, and body weight.

Conditions: Diabetes Mellitus, Type 2
Being tested: 5-ALA-SFC, Placebo
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

5-ALA-SFCDrug
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
PlaceboDrug

Study groups in NCT02481141
Study group	Role	What they receive
5-ALA-SFC	Active comparator	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 Receives: Drug: 5-ALA-SFC
Placebo	Placebo comparator	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 Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Subjects With Adverse Events as a Measure of Safety and Tolerability
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.
Measured: Week 2, Week 4, Week 12
Change From Baseline in Fasting Blood Glucose
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.
Measured: Baseline, Week 2, Week 4, Week 12

Secondary outcomes (7)

Change From Baseline in 2 Hour Post Meal Glucose Level
Change from baseline in blood glucose levels 2 hours after breakfast
Measured: Baseline, Week 2, Week 4, Week 12
Change From Baseline in Body Weight
Change from baseline measured at week 6 and week 12 only
Measured: Baseline, Week 6, Week 12
Change From Baseline in HbA1c
Change from baseline in HbA1c %
Measured: Baseline, Week 2, Week 4, Week 12
Change From Baseline in Total Cholesterol (Component of Lipid Profile)
Change from baseline measured at week 6 and week 12 only
Measured: Baseline, Week 6, Week 12
Change From Baseline LDL (Component of Lipid Profile)
Change from baseline measured at week 6 and week 12 only
Measured: Baseline, Week 6, Week 12
Change From Baseline in HDL (Component of Lipid Profile)
Change from baseline measured at week 6 and week 12 only
Measured: Baseline, Week 6, Week 12
Change From Baseline in Triglycerides (Component of Lipid Profile)
Change from baseline measured at week 6 and week 12 only
Measured: Baseline, Week 6, Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2014Jul 2015

First posted25 Jun 2015 (estimated)
Study startJul 2014
Primary completionJul 2015
Study completionJul 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 53 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02481141
Sponsor's protocol ID: SBIP12-002F
Status last verified: Apr 2018
First submitted: 17 Jun 2015
Last updated: 22 May 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Al-Saber F, Aldosari W, Alselaiti M, Khalfan H, Kaladari A, Khan G, Harb G, Rehani R, Kudo S, Koda A, Tanaka T, Nakajima M, Darwish A. The Safety and Tolerability of 5-Aminolevulinic Acid Phosphate with Sodium Ferrous Citrate in Patients with Type 2 Diabetes Mellitus in Bahrain. J Diabetes Res. 2016;2016:8294805. doi: 10.1155/2016/8294805. Epub 2016 Sep 22.
PubMed 27738640

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Diabetes Mellitus, Type 2 trials

Study at a glance

From the registry record, last updated by the sponsor on 22 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective, Randomized, Single-Blind, Placebo-Controlled, Dose-Escalation Pilot Study to Evaluate the Safety and Efficacy of 5-ALA-SFC in Subjects With Type II Diabetes
ClinicalTrials.gov ID: NCT02481141
Acronym / sponsor ID: SBIP12-002F
Conditions: Diabetes Mellitus, Type 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 53 participants (actual)
Lead sponsor: SBI Pharmaceuticals Co, Ltd.Industry (pharma, biotech, devices)
Study start: Jul 2014
Primary completion: Jul 2015 (actual)
Study completion: Jul 2015 (actual)
First posted: 25 Jun 2015 (estimated)
Results: Posted 11 Dec 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The aim of this pilot study is to assess the safety and preliminary efficacy of 5-ALA - SFC at doses up to 200 mg per day in subjects with type II diabetes.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
5-ALA-SFC	Active comparator	Drug: 5-ALA-SFCStudy 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
Placebo	Placebo comparator	Drug: PlaceboStudy 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

Who may qualify

Ages: 20 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Males and females residing in Bahrain aged 20 to 75 years old
Otherwise in good health in the opinion of the investigator based on results of medical history, physical exam and laboratory assessments
Diagnosed with type II diabetes mellitus with HbA1c >6.5 and <10% which is uncontrolled despite the use of one or more glycemia-lowering drugs
BMI ≤44 kg/m2
Sitting BP ≤ 160/100mm Hg

Key exclusion criteria (7 listed)

Liver dysfunction defined as liver function tests >1.5 times upper limit of normal
Renal dysfunction defined as BUN and/or serum creatinine >1.5 times upper limit of normal and/or eGFR <30 ml/min/1.73 m2
History of any life-threatening disease, cardiovascular disease, viral hepatitis, porphyria or hemochromatosis
Allergy to ALA, SFC, or any other component of study product
Use of insulin for management of serum glucose

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
5-ALA-SFCStudy 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	Drug	5-ALA-SFC
Placebo	Drug	Placebo

Primary outcome

Subjects With Adverse Events as a Measure of Safety and Tolerability
Time frame: Week 2, Week 4, Week 12
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.
Change From Baseline in Fasting Blood Glucose
Time frame: Baseline, Week 2, Week 4, Week 12
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.

7 secondary outcomes

Change From Baseline in 2 Hour Post Meal Glucose Level
Time frame: Baseline, Week 2, Week 4, Week 12
Change From Baseline in Body Weight
Time frame: Baseline, Week 6, Week 12
Change From Baseline in HbA1c
Time frame: Baseline, Week 2, Week 4, Week 12
Change From Baseline in Total Cholesterol (Component of Lipid Profile)
Time frame: Baseline, Week 6, Week 12
Change From Baseline LDL (Component of Lipid Profile)
Time frame: Baseline, Week 6, Week 12
Change From Baseline in HDL (Component of Lipid Profile)
Time frame: Baseline, Week 6, Week 12
Change From Baseline in Triglycerides (Component of Lipid Profile)
Time frame: Baseline, Week 6, Week 12

Results and safety

Results posted to the registry on 11 Dec 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
5-ALA-SFC	35	26
Placebo	18	13

Primary outcome: Subjects With Adverse Events as a Measure of Safety and Tolerability

Time frame: Week 2, Week 4, Week 12. Count of participants. Unit: Participants

Measure	5-ALA-SFC Through Week 2 (50 mg 2x/Day) n = 35	5-ALA-SFC Through Week 4 (75 mg 2x/Day) n = 35	5-ALA-SFC Through Week 12 (100 mg 2x/Day) n = 35	Placebo Through Week 2 n = 18	Placebo Through Week 4 n = 18	Placebo Through Week 12 n = 18
Value	6	8	2	3	1	1

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

Primary outcome: Change From Baseline in Fasting Blood Glucose

Time frame: Baseline, Week 2, Week 4, Week 12. Mean (Standard Error). Unit: mg/dL

Measure	5-ALA-SFC Through Week 2 (50 mg 2x/Day) Change From Baseline n = 33	5-ALA-SFC Through Week 4 (75 mg 2x/Day) Change From Baseline n = 30	5-ALA-SFC Through Wk 12 (100 mg 2x/Day) Change From Baseline n = 22	Placebo Through Week 2 Change From Baseline n = 14	Placebo Through Week 4 Change From Baseline n = 14	Placebo Through Week 12 Change From Baseline n = 12
Value	2.3 (3.4)	-0.2 (4.9)	-3.0 (4.4)	-7.3 (5.2)	-0.8 (7.2)	-4.2 (5.9)

Population analysed: 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.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: 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 reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
5-ALA-SFC Through Week 2	1 of 35 (2.9%)	6 of 35 (17.1%)	0 of 35
5-ALA-SFC Through Week 4	0 of 35 (0%)	14 of 35 (40%)	0 of 35
5-ALA-SFC Through Week 12	0 of 35 (0%)	16 of 35 (45.7%)	0 of 35
Placebo Through Week 2	0 of 18 (0%)	3 of 18 (16.7%)	0 of 18
Placebo Through Week 4	0 of 18 (0%)	4 of 18 (22.2%)	0 of 18
Placebo Through Week 12	0 of 18 (0%)	5 of 18 (27.8%)	0 of 18

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27738640Al-Saber F, Aldosari W, Alselaiti M, Khalfan H, Kaladari A, Khan G, Harb G, Rehani R, Kudo S, Koda A, Tanaka T, Nakajima M, Darwish A. The Safety and Tolerability of 5-Aminolevulinic Acid Phosphate with Sodium Ferrous Citrate in Patients with Type 2 Diabetes Mellitus in Bahrain. J Diabetes Res. 2016;2016:8294805. doi: 10.1155/2016/8294805. Epub 2016 Sep 22.

Related trials for Diabetes Mellitus, Type 2

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
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Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Riyadh Rehani, Ph.D. study director

SBI Pharmaceuticals Co, Ltd.

Questions about this trial

What is this clinical trial studying?

A study testing 5-ALA-SFC in people with Diabetes Mellitus, Type 2, run by SBI Pharmaceuticals Co, Ltd..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 May 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Subjects With Adverse Events as a Measure of Safety and Tolerability (time frame: Week 2, Week 4, Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02481141, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2018.