Type2 Diabetes MellitusPhase 4NCT04287387
Response of Gut Microbiota in Type 2 Diabetes to Hypoglycemic Agents
A Phase 4 study testing Glucophage 500Mg Tablet, Acarbose Tablets and Sitagliptin tablet in people with Type2 Diabetes Mellitus, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
Intestinal microflora refers to the trillions of microorganisms living in our gut, which is considered as an independent endocrine organ of human body. Intestinal microbiota plays a very important role in human health. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type2 Diabetes Mellitus
- What is being tested?
- Glucophage 500Mg Tablet, Acarbose Tablets and Sitagliptin tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 2 Mar 2020to 2 Mar 2021
- Phase
- Phase 4
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- According to the diagnostic criteria of World Health Organization (WHO) in 1999, type 2 diabetes mellitus was diagnosed clinically
- The age ranged from 18 to 65 years (including 18 and 65 years)
- Free of hypoglycemic drugs in the past 3 months; or have taken hypoglycemic drugs, and other hypoglycemic drugs need to be added at present.
- Sign written consent form voluntarily
Who cannot join
- Other types of diabetes mellitus
- At least in the last 1 month, no antibiotics or microbial agents have been used
- History of infectious diseases such as tuberculosis, viral hepatitis, HIV, and periodontal disease; history of dental disease
- Acute complications of diabetes mellitus within 6 months
- History of myocardial infarction or stroke within 6 months, or existing severe cardiovascular disease and risk
- Abnormal liver function [i.e. serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) is 1.5 times higher than the upper limit of normal value]；Abnormal renal function [glomerular filtration rate≤60 ml/min]
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- Severe hypertension that defined as systolic blood pressure ≥160 mmHg, diastolic blood pressure ≥90 mmHg with drug therapy, or hypotension (resting seat blood pressure < 90/50 mmHg)
- History of acute and chronic gastroenteritis or gastrointestinal surgery
- psychosis, alcohol dependence or history of drug abuse, lactation women, participation in other studies three months before the trial, allergic constitution or allergic to a variety of drug and those researchers think inappropriate to the research.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Weigang Zhao, MD, +86 69151876, xiehezhaoweigang@163.com
About this study
Intestinal microflora refers to the trillions of microorganisms living in our gut, which is considered as an independent endocrine organ of human body. Intestinal microbiota plays a very important role in human health. The composition of human intestinal microbiota is affected by a variety of factors, including age, living region, eating habits, nutrition, probiotics, antibiotics and so on. It is found that the imbalance of intestinal microbiota is closely related to the occurrence and development of metabolic diseases including type 2 diabetes mellitus (T2DM). There are great differences in the structure and function of intestinal microbiota between healthy people and T2DM patients, and recently changes of intestinal microbiota have been observed in pre-diabetes. In recent years, it has been found that some commonly used hypoglycemic drugs may regulate and improve the imbalance of intestinal flora of T2DM patients, including metformin, α - glucosidase inhibitor, and Glucagon-like peptide-1(GLP-1) receptor agonist, which have a positive impact on the short chain fatty acid (SCFAs) producing bacteria. However, on the one hand, subjects of those studies were mostly western population and there were just a few studies on the influence of anti-diabetic drug on human gut microbiota in Chinese population, on the other hand, the study of influence of Dipeptidyl peptidase-4(DPP-4) inhibitors, sulfonylureas, sodium-dependent glucose transporters-2(SGLT-2) inhibitors or thiazolidinediones on intestinal microbiota is rare or even absent. This study aims to explore the effect of different hypoglycemic drugs on intestinal flora and find the potential intestinal target of drug action in Chinese population.
Read the detailed description
In this study, T2DM patients who were free of anti-diabetic drugs or those have taken hypoglycemic drugs and ready to add a new drug were recruited, they were treated with metformin, α - glucosidase inhibitor, DPP-4 inhibitors, sulfonylureas, SGLT-2 inhibitors, or thiazolidinediones according to their state of illness. Faecal specimen will be collected for test of composition of gut microbiota at baseline and 4-week, 8-week，12-week after taking medication. At baseline, patients will take physical examination and blood test, every patient will complete the questionnaire under the direction of doctors to get their general information and diet habits. Physical examination and blood test will repeat at 4-week, 8-week，12-week after treatment.
- Conditions
- Type2 Diabetes Mellitus
- Being tested
- Glucophage 500Mg Tablet, Acarbose Tablets, Sitagliptin tablet, Dapagliflozin Tablet, Pioglitazone Tablets
- Keywords
- type 2 diabetes mellitus, gut microbiota, hypoglycemic drugs
- 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.
Glucophage 500Mg TabletDrug
0.5g three times daily
Acarbose TabletsDrug
50mg three times daily
Sitagliptin tabletDrug
100mg once daily
Dapagliflozin TabletDrug
10mg once daily
Pioglitazone TabletsDrug
30mg once daily
Glimepiride TabletsDrug
2mg once daily
| Study group | Role | What they receive |
|---|---|---|
| Glucophage group | Experimental | Not described Receives: Drug: Glucophage 500Mg Tablet |
| Acarbose group | Experimental | Not described Receives: Drug: Acarbose Tablets |
| Sitagliptin group | Experimental | Not described Receives: Drug: Sitagliptin tablet |
| Dapagliflozin group | Experimental | Not described Receives: Drug: Dapagliflozin Tablet |
| Pioglitazone group | Experimental | Not described Receives: Drug: Pioglitazone Tablets |
| Glimepiride group | Experimental | Not described Receives: Drug: Glimepiride Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline to post-treatment in composition in gut microbiota analyzed by meta-genome sequencing.
Measured: Baseline, Week 4, Week 8, Week 12
Changes from baseline to post-treatment in composition in fasting blood glucose.
Measured: Baseline, Week 4, Week 8, Week 12
Changes from baseline to post-treatment in composition in level of TNF-a.
Measured: Baseline, Week 4, Week 8, Week 12
Changes from baseline to post-treatment in composition in fasting insulin.
Measured: Baseline, Week 4, Week 8, Week 12
Changes from baseline to post-treatment in blood lipid including cholesterol, triglycerides, high-density lipoprotein.
Measured: Baseline, Week 4, Week 8, Week 12
Changes from baseline to post-treatment in composition in 2-hour postprandial blood glucose.
Measured: Baseline, Week 4, Week 8, Week 12
Changes from baseline to post-treatment in composition in level of IL-6.
Measured: Baseline, Week 4, Week 8, Week 12
Changes from baseline to post-treatment in composition in level of IL-8.
Measured: Baseline, Week 4, Week 8, Week 12
Changes from baseline to post-treatment in composition in level of IL-10.
Measured: Baseline, Week 4, Week 8, Week 12
Changes from baseline to post-treatment in composition in level of C-reative protein.
Measured: Baseline, Week 4, Week 8, Week 12
Secondary outcomes (2)
The linear relationship between gut microbiota and blood glucose and blood lipid level.
Measured: Week 4, Week 8, Week 12
The linear relationship between gut microbiota and inflammation factors level.
Measured: Week 4, Week 8, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2020
- Study start2 Mar 2020 (estimated)
- Primary completion2 Mar 2021 (estimated)
- Study completion2 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese Academy of Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04287387
- Sponsor's protocol ID
- APIMCAS2018001
- Status last verified
- Feb 2020
- First submitted
- 24 Feb 2020
- Last updated
- 27 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Response of Gut Microbiota in Type 2 Diabetes to Hypoglycemic Agents
- ClinicalTrials.gov ID
- NCT04287387
- Acronym / sponsor ID
- APIMCAS2018001
- Conditions
- Type2 Diabetes Mellitus
- Keywords
- type 2 diabetes mellitus, gut microbiota, hypoglycemic drugs
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Chinese Academy of Sciences
- Study start
- 2 Mar 2020 (estimated)
- Primary completion
- 2 Mar 2021 (estimated)
- Study completion
- 2 Mar 2021 (estimated)
- First posted
- 27 Feb 2020 (actual)
- 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.
Intestinal microflora refers to the trillions of microorganisms living in our gut, which is considered as an independent endocrine organ of human body. Intestinal microbiota plays a very important role in human health. The composition of human intestinal microbiota is affected by a variety of factors, including age, living region, eating habits, nutrition, probiotics, antibiotics and so on. It is found that the imbalance of intestinal microbiota is closely related to the occurrence and development of metabolic diseases including type 2 diabetes mellitus (T2DM). There are great differences in the structure and function of intestinal microbiota between healthy people and T2DM patients, and recently changes of intestinal microbiota have been observed in pre-diabetes. In recent years, it has been found that some commonly used hypoglycemic drugs may regulate and improve the imbalance of intestinal flora of T2DM patients, including metformin, α - glucosidase inhibitor, and Glucagon-like peptide-1(GLP-1) receptor agonist, which have a positive impact on the short chain fatty acid (SCFAs) producing bacteria. However, on the one hand, subjects of those studies were mostly western population and there were just a few studies on the influence of anti-diabetic drug on human gut microbiota in Chinese population, on the other hand, the study of influence of Dipeptidyl peptidase-4(DPP-4) inhibitors, sulfonylureas, sodium-dependent glucose transporters-2(SGLT-2) inhibitors or thiazolidinediones on intestinal microbiota is rare or even absent. This study aims to explore the effect of different hypoglycemic drugs on intestinal flora and find the potential intestinal target of drug action in Chinese population.
Detailed description
In this study, T2DM patients who were free of anti-diabetic drugs or those have taken hypoglycemic drugs and ready to add a new drug were recruited, they were treated with metformin, α - glucosidase inhibitor, DPP-4 inhibitors, sulfonylureas, SGLT-2 inhibitors, or thiazolidinediones according to their state of illness. Faecal specimen will be collected for test of composition of gut microbiota at baseline and 4-week, 8-week，12-week after taking medication. At baseline, patients will take physical examination and blood test, every patient will complete the questionnaire under the direction of doctors to get their general information and diet habits. Physical examination and blood test will repeat at 4-week, 8-week，12-week after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Glucophage group | Experimental | Drug: Glucophage 500Mg Tablet |
| Acarbose group | Experimental | Drug: Acarbose Tablets |
| Sitagliptin group | Experimental | Drug: Sitagliptin tablet |
| Dapagliflozin group | Experimental | Drug: Dapagliflozin Tablet |
| Pioglitazone group | Experimental | Drug: Pioglitazone Tablets |
| Glimepiride group | Experimental | Drug: Glimepiride Tablets |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- According to the diagnostic criteria of World Health Organization (WHO) in 1999, type 2 diabetes mellitus was diagnosed clinically
- The age ranged from 18 to 65 years (including 18 and 65 years)
- Free of hypoglycemic drugs in the past 3 months; or have taken hypoglycemic drugs, and other hypoglycemic drugs need to be added at present.
- Sign written consent form voluntarily
Key exclusion criteria (9 listed)
- Other types of diabetes mellitus
- At least in the last 1 month, no antibiotics or microbial agents have been used
- History of infectious diseases such as tuberculosis, viral hepatitis, HIV, and periodontal disease; history of dental disease
- Acute complications of diabetes mellitus within 6 months
- History of myocardial infarction or stroke within 6 months, or existing severe cardiovascular disease and risk
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 |
|---|---|---|
| Glucophage 500Mg Tablet0.5g three times daily | Drug | Glucophage group |
| Acarbose Tablets50mg three times daily | Drug | Acarbose group |
| Sitagliptin tablet100mg once daily | Drug | Sitagliptin group |
| Dapagliflozin Tablet10mg once daily | Drug | Dapagliflozin group |
| Pioglitazone Tablets30mg once daily | Drug | Pioglitazone group |
| Glimepiride Tablets2mg once daily | Drug | Glimepiride group |
Primary outcome
Changes from baseline to post-treatment in composition in gut microbiota analyzed by meta-genome sequencing.
Time frame: Baseline, Week 4, Week 8, Week 12
Changes from baseline to post-treatment in composition in fasting blood glucose.
Time frame: Baseline, Week 4, Week 8, Week 12
Changes from baseline to post-treatment in composition in level of TNF-a.
Time frame: Baseline, Week 4, Week 8, Week 12
Changes from baseline to post-treatment in composition in fasting insulin.
Time frame: Baseline, Week 4, Week 8, Week 12
Changes from baseline to post-treatment in blood lipid including cholesterol, triglycerides, high-density lipoprotein.
Time frame: Baseline, Week 4, Week 8, Week 12
Changes from baseline to post-treatment in composition in 2-hour postprandial blood glucose.
Time frame: Baseline, Week 4, Week 8, Week 12
Changes from baseline to post-treatment in composition in level of IL-6.
Time frame: Baseline, Week 4, Week 8, Week 12
Changes from baseline to post-treatment in composition in level of IL-8.
Time frame: Baseline, Week 4, Week 8, Week 12
Changes from baseline to post-treatment in composition in level of IL-10.
Time frame: Baseline, Week 4, Week 8, Week 12
Changes from baseline to post-treatment in composition in level of C-reative protein.
Time frame: Baseline, Week 4, Week 8, Week 12
2 secondary outcomes
The linear relationship between gut microbiota and blood glucose and blood lipid level.
Time frame: Week 4, Week 8, Week 12
The linear relationship between gut microbiota and inflammation factors level.
Time frame: Week 4, Week 8, Week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2020.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Glucophage 500Mg Tablet, Acarbose Tablets and Sitagliptin tablet in people with Type2 Diabetes Mellitus, run by Peking Union Medical College Hospital at 1 site in China.
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 9 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: status not confirmed, as of the sponsor's last update on 27 Feb 2020. 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 China. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Weigang zhao, MD (+86 69151876, xiehezhaoweigang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline to post-treatment in composition in gut microbiota analyzed by meta-genome sequencing. (time frame: Baseline, Week 4, Week 8, Week 12). The study lists 10 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 27 Feb 2020.