Type 2 DiabetesPhase 4NCT01758471
Efficacy of Acarbose on Intestinal Microbiome and Incretins of Type 2 Diabetes
A Phase 4 study testing Glipizide and Acarbose in people with Type 2 Diabetes, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
This study is aimed to investigate the effect of acarbose on intestinal microbiome and incretins, therefore to explore the new pathways or new targets to treat type 2 diabetes. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Glipizide and Acarbose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- Dec 2012to Jun 2014
- 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 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Newly diagnosed Type 2 Diabetes, without any previous drug treatment,
- 7.0 mmol/l <=FBG<=13.O mmol/l, HbA1C <=10%
- Body mass index (BMI) < 35kg/m2 (inclusive);
- Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted
- Having good study compliance
Who cannot join
- Intestinal surgery or recent abdominal surgery within 1 year
- Taken immunosuppressive agents, steroid,antidiarrhea agents, antibiotics and other gastrointestinal motility agents within 3 months
- Severe liver dysfunction, including serum alanine aminotransferase concentration more than 2.5 times above upper limit of normal range, abnormal renal function (GFR < 60ml/min)
- Other severe conditions which will put the patients in high risk during the study
- Any clinically significant allergic disease
- Women in pregnancy or under breast feeding
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Clinic Center for Endocrine and Metabolic Diseases, Ruijin Hospital, Shanghai Institute for Endocrine and Metabolic Diseases
Shanghai, Shanghai Municipality, 200025
Guang Ning, M.D., 86-021-64370045 ext. 665344
About this study
Official title: An Open-label, Randomized , Phase 4 Study to Compare the Different Efficacies of α-glucosidase Inhibitor and Sulfonylurea on Improvement of Intestinal Microbiome and Serum Incretins in Patients With Type 2 Diabetes
This study is aimed to investigate the effect of acarbose on intestinal microbiome and incretins, therefore to explore the new pathways or new targets to treat type 2 diabetes.
Read the detailed description
In recent years, Endocrinologist and Diabetologists have found that intestine might serve as a novel target for treating diabetes or other metabolic diseases. Incretins are well-known hormones secreted from intestine, such as CCK（Cholecystokinin), Serotonin, GIP(gastric inhibitory polypeptide) and GLP-1(glucagon like peptide 1), to help control wholesome metabolic status through their effects on pancreatic islet cells, hypothalamus neurons and gastrointestinal movement. Gut microbiome has been recently revealed exerting major effect on host's immune system and metabolic balance with its various metabolites and components.
α-glucosidase inhibitors have been used as anti-diabetes medicine for dozens of years. They are known to be effective by delaying glucose absorption in small intestine. Questions then have been arisen that if delaying glucose absorption changes the intestinal bacteria flora component by increasing bacteria fed on glucose, or that if it influences incretin secretion, since most glucose sensitive L cell (secreting GLP-1) were located in the distal part of small intestine and colon, and that if the hypoglycemia effect of α-glucosidase inhibitors might be mediated by either intestinal flora or incretins.
To address the questions above and to find the new targets from the intestine to treat diabetes, we therefore design this study, taking advantage of clinical trial and basic biomedical studies to find if α-glucosidase inhibitor- Acarbose (Bayer, Corp.) could change the profile of intestinal incretins and microbiome.
Study design:
- Multi-center, open label, randomized, positive control cohort.
- 110 cases of newly-diagnosed Type-2 Diabetes patients from five clinic centers from Shanghai, China Mainland.
- All patients will sign the consent and screened by the criteria before enrolled by this study.
- 55 cases of Type 2 Diabetes will be assigned to glucobay treatment and another 55 will take glipizide.
- 50 healthy volunteers for baseline data comparison.
- The duration of whole study will be 3 month.
- Before treatment, all the patients will be required to have OGTT(oral glucose tolerant test) and IRT(insulin release test) test and give their feces. Standard meals will be required one day before the feces are collected.
- In 3 months, all patients will take the medicine and their glucose will be monitored closely by visiting outpatient office once a month.
- In the end of the study, patients will be required to receive OGTT and IRT and give their feces again.
- Serum and feces will be stored at -80℃ for further biomarkers investigation and microbiome sequencing.
- After 3 months intervention, patients will be observed for another 3 month with access to routine clinic visiting.
- Conditions
- Type 2 Diabetes
- Being tested
- Glipizide, Acarbose
- Keywords
- Type 2 Diabetes, gut microbiome, incretin, Sulfonylurea, α-glucosidase inhibitor
- 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.
GlipizideDrug
glipizide 5mg per pill 5mg tid p.o. for 3 month
AcarboseDrug
Also called glucobay
Acarbose 50mg per pill 100mg to 150mgtid p.o.（oral） for 3 month
| Study group | Role | What they receive |
|---|---|---|
| Acarbose | Experimental | The minimum dosage of acarbose in this study is 100mg tid p.o.(oral) for 3 month. With this dosage, patients should have similar glycemic control with those using glipizide, that is FBG(fasting blood glucose)<7.0,PBG(postprandial blood glucose)<10.0 Receives: Drug: Acarbose |
| glipizide | Active comparator | There is no fixed dosage of glipizide to control hyperglycemia for patients in this group. As long as the targeted blood glucose concentration is reached, FBG< 7.0, PBG< 10.0, patients will have the least dosage of glipizide according to their glucose level. Receives: Drug: Glipizide |
What is being measured
The primary outcome is the main question the study is designed to answer.
euglycemia
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2013 (estimated)
- Study startDec 2012
- Primary completionDec 2013 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guang Ning, Shanghai Jiao Tong University School of Medicine
- Investigators
- Guang Ning, M.D. Ph.D., Principal investigator, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01758471
- Sponsor's protocol ID
- CCEMD017
- Status last verified
- Dec 2012
- First submitted
- 24 Dec 2012
- Last updated
- 1 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ni M, Chen Y, Gu W, Zhang Y, Xu M, Gu Y, Chen Y, Zhu Y, Wang X, Luo Y, Xu Y, Lin X, Zeng YA, Liu R, Wang J. Association Between Circulating Gremlin 2 and beta-Cell Function Among Participants With Prediabetes and Type 2 Diabetes. J Diabetes. 2025 Apr;17(4):e70090. doi: 10.1111/1753-0407.70090.
PubMed 40270326
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized , Phase 4 Study to Compare the Different Efficacies of α-glucosidase Inhibitor and Sulfonylurea on Improvement of Intestinal Microbiome and Serum Incretins in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01758471
- Acronym / sponsor ID
- CCEMD017
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 Diabetes, gut microbiome, incretin, Sulfonylurea, α-glucosidase inhibitor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 1 Jan 2013 (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.
This study is aimed to investigate the effect of acarbose on intestinal microbiome and incretins, therefore to explore the new pathways or new targets to treat type 2 diabetes.
Detailed description
In recent years, Endocrinologist and Diabetologists have found that intestine might serve as a novel target for treating diabetes or other metabolic diseases. Incretins are well-known hormones secreted from intestine, such as CCK（Cholecystokinin), Serotonin, GIP(gastric inhibitory polypeptide) and GLP-1(glucagon like peptide 1), to help control wholesome metabolic status through their effects on pancreatic islet cells, hypothalamus neurons and gastrointestinal movement. Gut microbiome has been recently revealed exerting major effect on host's immune system and metabolic balance with its various metabolites and components.
α-glucosidase inhibitors have been used as anti-diabetes medicine for dozens of years. They are known to be effective by delaying glucose absorption in small intestine. Questions then have been arisen that if delaying glucose absorption changes the intestinal bacteria flora component by increasing bacteria fed on glucose, or that if it influences incretin secretion, since most glucose sensitive L cell (secreting GLP-1) were located in the distal part of small intestine and colon, and that if the hypoglycemia effect of α-glucosidase inhibitors might be mediated by either intestinal flora or incretins.
To address the questions above and to find the new targets from the intestine to treat diabetes, we therefore design this study, taking advantage of clinical trial and basic biomedical studies to find if α-glucosidase inhibitor- Acarbose (Bayer, Corp.) could change the profile of intestinal incretins and microbiome.
Study design:
- Multi-center, open label, randomized, positive control cohort.
- 110 cases of newly-diagnosed Type-2 Diabetes patients from five clinic centers from Shanghai, China Mainland.
- All patients will sign the consent and screened by the criteria before enrolled by this study.
- 55 cases of Type 2 Diabetes will be assigned to glucobay treatment and another 55 will take glipizide.
- 50 healthy volunteers for baseline data comparison.
- The duration of whole study will be 3 month.
- Before treatment, all the patients will be required to have OGTT(oral glucose tolerant test) and IRT(insulin release test) test and give their feces. Standard meals will be required one day before the feces are collected.
- In 3 months, all patients will take the medicine and their glucose will be monitored closely by visiting outpatient office once a month.
- In the end of the study, patients will be required to receive OGTT and IRT and give their feces again.
- Serum and feces will be stored at -80℃ for further biomarkers investigation and microbiome sequencing.
- After 3 months intervention, patients will be observed for another 3 month with access to routine clinic visiting.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acarbose | Experimental | Drug: AcarboseThe minimum dosage of acarbose in this study is 100mg tid p.o.(oral) for 3 month. With this dosage, patients should have similar glycemic control with those using glipizide, that is FBG(fasting blood glucose)<7.0,PBG(postprandial blood glucose)<10.0 |
| glipizide | Active comparator | Drug: GlipizideThere is no fixed dosage of glipizide to control hyperglycemia for patients in this group. As long as the targeted blood glucose concentration is reached, FBG< 7.0, PBG< 10.0, patients will have the least dosage of glipizide according to their glucose level. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Newly diagnosed Type 2 Diabetes, without any previous drug treatment,
- 7.0 mmol/l <=FBG<=13.O mmol/l, HbA1C <=10%
- Body mass index (BMI) < 35kg/m2 (inclusive);
- Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted
- Having good study compliance
Key exclusion criteria (6 listed)
- Intestinal surgery or recent abdominal surgery within 1 year
- Taken immunosuppressive agents, steroid,antidiarrhea agents, antibiotics and other gastrointestinal motility agents within 3 months
- Severe liver dysfunction, including serum alanine aminotransferase concentration more than 2.5 times above upper limit of normal range, abnormal renal function (GFR < 60ml/min)
- Other severe conditions which will put the patients in high risk during the study
- Any clinically significant allergic disease
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 |
|---|---|---|
| Glipizideglipizide 5mg per pill 5mg tid p.o. for 3 month | Drug | glipizide |
| AcarboseAlso: glucobayAcarbose 50mg per pill 100mg to 150mgtid p.o.（oral） for 3 month | Drug | Acarbose |
Primary outcome
euglycemia
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2013.
- Derived from this study: PubMed 40270326Ni M, Chen Y, Gu W, Zhang Y, Xu M, Gu Y, Chen Y, Zhu Y, Wang X, Luo Y, Xu Y, Lin X, Zeng YA, Liu R, Wang J. Association Between Circulating Gremlin 2 and beta-Cell Function Among Participants With Prediabetes and Type 2 Diabetes. J Diabetes. 2025 Apr;17(4):e70090. doi: 10.1111/1753-0407.70090.
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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.
Guang Ning, M.D. Ph.D. principal investigator
Shanghai Jiao Tong University School of Medicine
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 Glipizide and Acarbose in people with Type 2 Diabetes, run by Shanghai Jiao Tong University School of Medicine 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 5 inclusion and 6 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 1 Jan 2013. 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 Guang Ning, M.D. Ph.D. (86-021-64370045 ext. 665344, guangning@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
euglycemia (time frame: 3 months). 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 NCT01758471, 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 1 Jan 2013.