Type 2 DiabetesPhase 2NCT02274272
Effects of Genmont Probiotic on Improve the Level of Blood Glucose and Other Diabetic Associate Parameter in Type 2 Diabetes Patients
A Phase 2 study testing ADR-1 and GMNL-263 in people with Type 2 Diabetes, run by GenMont Biotech Incorporation at 1 site in Taiwan.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of probiotics ADR-1/GMNL-263 capsules (Lactobacillus reuteri ADR-1/ Lactobacillus reuteri GMNL-263) for the treatment of adults with type2 DM. Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- ADR-1 and GMNL-263
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2014to May 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes with a duration> 6 months
- 7 % < HbA1c ≦ 10 %
- Adults 25- 70 years of age
- BMI>18.5
Who cannot join
- Pregnancy
- Subjects with any other serious diseases such as cancer (patient with benign tumor under medical control should not be ruled out), kidney failure / dialysis, heart disease, stroke.
- Autoimmune Disease
- Administration of other healthy food for diabetes 4 weeks before inclusion
- Administration of probiotic 4 weeks before inclusion
- Administration of antibiotics 4 weeks before inclusion
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- Participation in other clinical trials
- ALT/SGPT or AST/SGOT > 3x upper limit of normal (ULN)
- eGFR<30mL/min/1.73m2
- Subjects who is lack of physical integrity of gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the efficacy and safety of probiotics ADR-1/GMNL-263 capsules (Lactobacillus reuteri ADR-1/ Lactobacillus reuteri GMNL-263) for the treatment of adults with type2 DM.
Read the detailed description
Background：Based on animal studies, intake of probiotic bacteria was suggested to improve insulin sensitivity by reducing inflammation.
Objective ： The objective of this study was to determine the effects of supplementation with the probiotic strain Lactobacillus reuteri ADR-1(ADR-1) and Lactobacillus reuteri GMNL-263 (GMNL-263) over six months on metabolic profiles, intestinal microbiota profiles and biomarkers of inflammation in type 2 diabetes patents. Methods ： This randomized double-blind placebo-controlled clinical trial was performed on 120 diabetic patients. Subjects were divided into 3 groups: 40 subjects in the group A received placebo, 40 subjects in the group B received ADR-1 (4 x 109 colony-forming units/d), and 40 subjects in the group C received GMNL-263. (2 x 1010 cells/d) for 6 months. Fasting blood samples were taken at baseline and after intervention to measure metabolic profiles and biomarkers of inflammation including C reactive protein (CRP), Interleukin 6 (IL-6) and Tumor necrosis factor-alpha( TNF-α). The intestinal microbiota profiles were detected in stool samples by real-time polymerase chain reaction (RT-PCR).
- Conditions
- Type 2 Diabetes
- Being tested
- ADR-1, GMNL-263, placebo
- Keywords
- lactobacillus reuteri, type 2 diabetes
- 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.
ADR-1Other
Also called Lactobacillus reuteri GMNL-89
two ADR-1 capsules, once daily, QD
GMNL-263Other
Also called Lactobacillus reuteri GMNL-263
two GMNL-263 capsules, once daily, QD
placeboOther
two placebo capsules, once daily, QD
| Study group | Role | What they receive |
|---|---|---|
| Placebo Capsules | Placebo comparator | Not described Receives: Other: placebo |
| ADR-1 | Experimental | Lactobacillus reuteri GMNL-89 Receives: Other: ADR-1 |
| GMNL-263 | Experimental | Lactobacillus reuteri GMNL-263 Receives: Other: GMNL-263 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood sugar
Fasting blood samples of 120 diabetic patients will be were taken at baseline and after intervention to measure blood sugar(mg/dL) and HbA1c(%).
Measured: 6 months
Change in blood fat
Fasting blood samples of 120 diabetic patients will be were taken at baseline and after intervention to measure cholesterol(mg/dL) ,triglycerides(TG, mg/dl), high density lipoprotein (HDL, mg/dl), low density lipoprotein (LDL, mg/dl).
Measured: 6 months
Secondary outcomes (1)
Change in the DM marker
Fasting blood samples of 120 diabetic patients will be were taken at baseline and after intervention to measure insulin(μIU/mL), C-peptide(ng/mL), Homeostasis model assessment for insulin resistance (HOMA-IR, ratio)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionApr 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- GenMont Biotech Incorporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- yi shing Chen, PhD, Study director, GenMont Biothech Incorporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02274272
- Sponsor's protocol ID
- P201404-31
- Status last verified
- Oct 2017
- First submitted
- 8 Oct 2014
- Last updated
- 12 Oct 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Genmont Probiotic on Improve the Level of Blood Glucose and Other Diabetic Associate Parameter in Type 2 Diabetes Patients
- ClinicalTrials.gov ID
- NCT02274272
- Acronym / sponsor ID
- P201404-31
- Conditions
- Type 2 Diabetes
- Keywords
- lactobacillus reuteri, type 2 diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- GenMont Biotech IncorporationIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Apr 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 24 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy and safety of probiotics ADR-1/GMNL-263 capsules (Lactobacillus reuteri ADR-1/ Lactobacillus reuteri GMNL-263) for the treatment of adults with type2 DM.
Detailed description
Background：Based on animal studies, intake of probiotic bacteria was suggested to improve insulin sensitivity by reducing inflammation.
Objective ： The objective of this study was to determine the effects of supplementation with the probiotic strain Lactobacillus reuteri ADR-1(ADR-1) and Lactobacillus reuteri GMNL-263 (GMNL-263) over six months on metabolic profiles, intestinal microbiota profiles and biomarkers of inflammation in type 2 diabetes patents. Methods ： This randomized double-blind placebo-controlled clinical trial was performed on 120 diabetic patients. Subjects were divided into 3 groups: 40 subjects in the group A received placebo, 40 subjects in the group B received ADR-1 (4 x 109 colony-forming units/d), and 40 subjects in the group C received GMNL-263. (2 x 1010 cells/d) for 6 months. Fasting blood samples were taken at baseline and after intervention to measure metabolic profiles and biomarkers of inflammation including C reactive protein (CRP), Interleukin 6 (IL-6) and Tumor necrosis factor-alpha( TNF-α). The intestinal microbiota profiles were detected in stool samples by real-time polymerase chain reaction (RT-PCR).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo Capsules | Placebo comparator | Other: placebo |
| ADR-1 | Experimental | Other: ADR-1Lactobacillus reuteri GMNL-89 |
| GMNL-263 | Experimental | Other: GMNL-263Lactobacillus reuteri GMNL-263 |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Type 2 diabetes with a duration> 6 months
- 7 % < HbA1c ≦ 10 %
- Adults 25- 70 years of age
- BMI>18.5
Key exclusion criteria (10 listed)
- Pregnancy
- Subjects with any other serious diseases such as cancer (patient with benign tumor under medical control should not be ruled out), kidney failure / dialysis, heart disease, stroke.
- Autoimmune Disease
- Administration of other healthy food for diabetes 4 weeks before inclusion
- Administration of probiotic 4 weeks before inclusion
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 |
|---|---|---|
| ADR-1Also: Lactobacillus reuteri GMNL-89two ADR-1 capsules, once daily, QD | Other | ADR-1 |
| GMNL-263Also: Lactobacillus reuteri GMNL-263two GMNL-263 capsules, once daily, QD | Other | GMNL-263 |
| placebotwo placebo capsules, once daily, QD | Other | Placebo Capsules |
Primary outcome
Change in blood sugar
Time frame: 6 months
Fasting blood samples of 120 diabetic patients will be were taken at baseline and after intervention to measure blood sugar(mg/dL) and HbA1c(%).
Change in blood fat
Time frame: 6 months
Fasting blood samples of 120 diabetic patients will be were taken at baseline and after intervention to measure cholesterol(mg/dL) ,triglycerides(TG, mg/dl), high density lipoprotein (HDL, mg/dl), low density lipoprotein (LDL, mg/dl).
1 secondary outcome
Change in the DM marker
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2017.
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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.
yi shing Chen, PhD study director
GenMont Biothech Incorporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ADR-1 and GMNL-263 in people with Type 2 Diabetes, run by GenMont Biotech Incorporation at 1 site in Taiwan.
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 4 inclusion and 10 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 12 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in blood sugar (time frame: 6 months). 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?
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 12 Oct 2017; AzTrials last refreshed its copy on 8 Nov 2026.