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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5-ALA-SFC | Drug | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Baseline, Week 2, Week 4, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in 2 Hour Post Meal Glucose Level | Change from baseline in blood glucose levels 2 hours after breakfast | Baseline, Week 2, Week 4, Week 12 |
| Change From Baseline in Body Weight |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Riyadh Rehani, Ph.D. | SBI Pharmaceuticals Co, Ltd. | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27738640 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Safety population included all subjects who took at least one dose of study product. | Posted | Count of Participants | Participants | Week 2, Week 4, Week 12 |
|
All Adverse Events were collected during the 12 week period subjects were in the study and taking either 5-ALA-SFC or Placebo.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 5-ALA-SFC Through Week 2 | Beginning Week 0: 1 capsule of 50mg 5-ALA-SFC twice per day for 2 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abscess in the nose | Infections and infestations | MedDRA (10.0) | One serious adverse event of a nasal abscess requiring hospitalization was reported by a subject receiving 5-ALA-SFC, which was not related to study product. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA (10.0) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Riyadh Rehani, President of MENA Region | SBI Pharmaceuticals Co, Ltd. | +973 66394100 | rrehani@sbigroup.co.jp |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Placebo | Drug |
|
Change from baseline measured at week 6 and week 12 only
| Baseline, Week 6, Week 12 |
| Change From Baseline in HbA1c | Change from baseline in HbA1c % | 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 | Baseline, Week 6, Week 12 |
| Change From Baseline LDL (Component of Lipid Profile) | Change from baseline measured at week 6 and week 12 only | 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 | 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 | Baseline, Week 6, Week 12 |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Study product administration will be as follows:
Beginning Week 2: 1 capsule of 75mg 5-ALA-SFC twice per day for 2 weeks
| OG002 | 5-ALA-SFC Through Week 12 (100 mg 2x/Day) | Study product administration will be as follows: Beginning Week 2: 1 capsule of 75mg 5-ALA-SFC twice per day for 2 weeks |
| OG003 | Placebo Through Week 2 | Study matching placebo administration will be as follows: Beginning Week 0: 1 capsule twice per day for 2 weeks |
| OG004 | Placebo Through Week 4 | Study matching placebo administration will be as follows: Beginning Week 2: 1 capsule twice per day for 2 weeks |
| OG005 | Placebo Through Week 12 | Study matching placebo administration will be as follows: Beginning Week 4: 1 capsule twice per day for 8 weeks |
|
|
| Primary | 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. | 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. | Posted | Mean | Standard Error | mg/dL | Baseline, Week 2, Week 4, Week 12 |
|
|
|
| Secondary | Change From Baseline in 2 Hour Post Meal Glucose Level | Change from baseline in blood glucose levels 2 hours after breakfast | 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. | Posted | Mean | Standard Error | mg/dL | Baseline, Week 2, Week 4, Week 12 |
|
|
|
| Secondary | Change From Baseline in Body Weight | Change from baseline measured at week 6 and week 12 only | 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. | Posted | Mean | Standard Error | kg | Baseline, Week 6, Week 12 |
|
|
|
| Secondary | Change From Baseline in HbA1c | Change from baseline in HbA1c % | 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. | Posted | Mean | Standard Error | percentage of HbA1c | Baseline, Week 2, Week 4, Week 12 |
|
|
|
| Secondary | Change From Baseline in Total Cholesterol (Component of Lipid Profile) | Change from baseline measured at week 6 and week 12 only | 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. | Posted | Mean | Standard Error | mg/dL | Baseline, Week 6, Week 12 |
|
|
|
| Secondary | Change From Baseline LDL (Component of Lipid Profile) | Change from baseline measured at week 6 and week 12 only | 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. | Posted | Mean | Standard Error | mg/dL | Baseline, Week 6, Week 12 |
|
|
|
| Secondary | Change From Baseline in HDL (Component of Lipid Profile) | Change from baseline measured at week 6 and week 12 only | 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. | Posted | Mean | Standard Error | mg/dL | Baseline, Week 6, Week 12 |
|
|
|
| Secondary | Change From Baseline in Triglycerides (Component of Lipid Profile) | Change from baseline measured at week 6 and week 12 only | 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. | Posted | Mean | Standard Error | mg/dL | Baseline, Week 6, Week 12 |
|
|
|
| 0 |
| 35 |
| 1 |
| 35 |
| 6 |
| 35 |
| EG001 | 5-ALA-SFC Through Week 4 | Beginning Week 2: 1 capsule of 75mg 5-ALA-SFC twice per day for 2 weeks | 0 | 35 | 0 | 35 | 14 | 35 |
| EG002 | 5-ALA-SFC Through Week 12 | Beginning Week 4: 1 capsule of 100mg 5-ALA-SFC twice per day for 8 weeks | 0 | 35 | 0 | 35 | 16 | 35 |
| EG003 | Placebo Through Week 2 | Beginning Week 0: 1 placebo capsule twice per day for 2 weeks | 0 | 18 | 0 | 18 | 3 | 18 |
| EG004 | Placebo Through Week 4 | Beginning Week 2: 1 placebo capsule twice per day for 2 weeks | 0 | 18 | 0 | 18 | 4 | 18 |
| EG005 | Placebo Through Week 12 | Beginning Week 4: 1 placebo capsule twice per day for 8 weeks | 0 | 18 | 0 | 18 | 5 | 18 |
|
| Abdominal Distension | Gastrointestinal disorders | MedDRA (10.0) |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (10.0) |
|
| Constipation | Gastrointestinal disorders | MedDRA (10.0) |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (10.0) |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (10.0) |
|
| Faeces discoloured | Gastrointestinal disorders | MedDRA (10.0) |
|
| Faeces hard | Gastrointestinal disorders | MedDRA (10.0) |
|
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA (10.0) |
|
| Nausea | Gastrointestinal disorders | MedDRA (10.0) |
|
| Fatigue | General disorders | MedDRA (10.0) |
|
| Pyrexia | General disorders | MedDRA (10.0) |
|
| Blood Glucose Increased | Investigations | MedDRA (10.0) |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (10.0) |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (10.0) |
|
| Hypokalemia | Metabolism and nutrition disorders | MedDRA (10.0) |
|
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) |
|
| Headache | Nervous system disorders | MedDRA (10.0) |
|
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA (10.0) |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (10.0) |
|
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| D004700 | Endocrine System Diseases |