DiabetesINTESTINENCT02609815
Initial Combination of Gemigliptin and Metformin on Microbiota Change
A study testing gemigliptin/metformin and glimepiride/metformin in people with Diabetes, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to investigate gut microbiota change and glucose lowering effect of initial combination therapy of gemigliptin and metformin compared to glimepiride and metformin in obese patients with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Diabetes
- What is being tested?
- gemigliptin/metformin and glimepiride/metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Nov 2015to 15 Mar 2021
- Phase
- Interventional
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes
- Drug naive (no anti-diabetic medication within 6 weeks)
- HbA1c >= 7.5%
- BMI >= 25.0 kg/m2
Who cannot join
- Type 1 diabetes
- DKA, HHS
- history of hypersensitivity to sulphonylurea, metformin or DPP-4 inhibitor
- Gestational diabetes mellitus
- Serum Cr >1.5 mg/dL (male), >1.4mg/dL (female)
- Abnormal liver function test
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- Anti-obesity medication within 3 months
- Gastrointestinal motility drug, laxatives within 3 months
- History of major gastrointestinal surgery
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
About this study
Official title: Effect of INitial Combination Therapy With GEmigliptin and Metformin on Microbiota Change and Glycemic Control in patientS With Type 2 DIabetes aNd ObEsity (INTESTINE Study)
The purpose of this study is to investigate gut microbiota change and glucose lowering effect of initial combination therapy of gemigliptin and metformin compared to glimepiride and metformin in obese patients with type 2 diabetes.
Read the detailed description
Obese type 2 diabetes patients who were not treated with anti-diabetic medication within 6 weeks, were randomly assigned to gemigliptin/metformin or sulphonylurea/metformin. After 24 week treatment, gut microbiota composition change, glucose lowering effect, body weight, and gut hormones were compared between two groups.
- Conditions
- Diabetes
- Being tested
- gemigliptin/metformin, glimepiride/metformin
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gemigliptin/metforminDrug
Also called Zemimet
zemimet-SR 50/1000 mg x 1 tablet
glimepiride/metforminDrug
Also called Amarylmex
amaryl-Mex 1/500 mg x 2 tablets
| Study group | Role | What they receive |
|---|---|---|
| gemigliptin/metformin | Experimental | zemimet-SR 50/1000 mg x 1 tablet Receives: Drug: gemigliptin/metformin |
| glimepiride/metformin | Active comparator | amaryl-Mex 1/500 mg x 2 tablets Receives: Drug: glimepiride/metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
gut microbiota composition change from baseline
Analysis of gut microbiota composition at class, genus, and species levels before and after treatment. Inter-individual changes of gut microbiota changes were analyzed.
Measured: 24 weeks
Secondary outcomes (1)
HbA1c change
HbA1c change from baseline to 24 weeks
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study start1 Nov 2015
- Primary completion15 Mar 2021
- Study completion15 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soo Lim, Seoul National University Bundang Hospital
- Investigators
- Tae Jung Oh, Study director, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02609815
- Sponsor's protocol ID
- SNUBH-INTESTINE2015
- Acronym
- INTESTINE
- Status last verified
- Nov 2021
- First submitted
- 13 Nov 2015
- Last updated
- 22 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of INitial Combination Therapy With GEmigliptin and Metformin on Microbiota Change and Glycemic Control in patientS With Type 2 DIabetes aNd ObEsity (INTESTINE Study)
- ClinicalTrials.gov ID
- NCT02609815
- Acronym / sponsor ID
- INTESTINE / SNUBH-INTESTINE2015
- Conditions
- Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 1 Nov 2015 (actual)
- Primary completion
- 15 Mar 2021 (actual)
- Study completion
- 15 Mar 2021 (actual)
- First posted
- 20 Nov 2015 (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 investigate gut microbiota change and glucose lowering effect of initial combination therapy of gemigliptin and metformin compared to glimepiride and metformin in obese patients with type 2 diabetes.
Detailed description
Obese type 2 diabetes patients who were not treated with anti-diabetic medication within 6 weeks, were randomly assigned to gemigliptin/metformin or sulphonylurea/metformin. After 24 week treatment, gut microbiota composition change, glucose lowering effect, body weight, and gut hormones were compared between two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| gemigliptin/metformin | Experimental | Drug: gemigliptin/metforminzemimet-SR 50/1000 mg x 1 tablet |
| glimepiride/metformin | Active comparator | Drug: glimepiride/metforminamaryl-Mex 1/500 mg x 2 tablets |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Type 2 diabetes
- Drug naive (no anti-diabetic medication within 6 weeks)
- HbA1c >= 7.5%
- BMI >= 25.0 kg/m2
Key exclusion criteria (9 listed)
- Type 1 diabetes
- DKA, HHS
- history of hypersensitivity to sulphonylurea, metformin or DPP-4 inhibitor
- Gestational diabetes mellitus
- Serum Cr >1.5 mg/dL (male), >1.4mg/dL (female)
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 |
|---|---|---|
| gemigliptin/metforminAlso: Zemimetzemimet-SR 50/1000 mg x 1 tablet | Drug | gemigliptin/metformin |
| glimepiride/metforminAlso: Amarylmexamaryl-Mex 1/500 mg x 2 tablets | Drug | glimepiride/metformin |
Primary outcome
gut microbiota composition change from baseline
Time frame: 24 weeks
Analysis of gut microbiota composition at class, genus, and species levels before and after treatment. Inter-individual changes of gut microbiota changes were analyzed.
1 secondary outcome
HbA1c change
Time frame: 24 weeks
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 22 Nov 2021.
- 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.
Tae Jung Oh study director
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gemigliptin/metformin and glimepiride/metformin in people with Diabetes, run by Seoul National University Bundang Hospital at 1 site in South Korea.
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: finished, as of the sponsor's last update on 22 Nov 2021. 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 South Korea. 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.
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?
gut microbiota composition change from baseline (time frame: 24 weeks). 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 22 Nov 2021.