Type 2 DiabetesPhase 4NCT02583438
Evaluate the Effect of Saxagliptin on Gut Microbiota in Patients With Newly Diagnosed Type 2 Diabetes
A Phase 4 study testing Saxagliptin (Bristol-Myers Squibb Company) in people with Type 2 Diabetes and Obesity, run by Beijing Chao Yang Hospital.
Trial summary
The intestinal microflora imbalance has been associated with obesity and type 2 diabetes. The researchers' study aimed to investigate the effect of saxagliptin on gut microbiota in patients with newly diagnosed type 2 diabetes. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Type 2 Diabetes, Obesity
- What is being tested?
- Saxagliptin (Bristol-Myers Squibb Company)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to Jan 2018
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females or males, and aged 20 to 65 years.
- Newly diagnosed type 2 diabetes
- HbA1C ≥7% and HbA1C <9%
Who cannot join
- Hepatic insufficiency (ALT or AST> 1.5*ULN)
- Renal insufficiency [Creatinine clearance rate (Ccr)]<60ml/min estimated from MDRD equation)
- Coronary artery disease
- Thyroid disease
- Infectious disease
- Systemic inflammatory disease
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- Cancer
- Subjects who were taking agents known to influence gut microbiota
- Pregnant or lactating woman
- Other conditions at investigator's discretion
About this study
Official title: Beijing Chao-yang Hospital, Capital Medical University
The intestinal microflora imbalance has been associated with obesity and type 2 diabetes. The researchers' study aimed to investigate the effect of saxagliptin on gut microbiota in patients with newly diagnosed type 2 diabetes.
- Conditions
- Type 2 Diabetes, Obesity
- Being tested
- Saxagliptin (Bristol-Myers Squibb Company)
- Keywords
- Gut Microbiota, inflammatory marker, Glucose and lipid metabolism
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saxagliptin (Bristol-Myers Squibb Company)Drug
6-month treatment of Saxagliptin 5mg Qd
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle intervention | Experimental | Not described Receives: Drug: Saxagliptin (Bristol-Myers Squibb Company) |
What is being measured
The primary outcome is the main question the study is designed to answer.
gut microbiota
Measured: Change from Baseline Bacteroidetes abundances and composition of gut microbiota at 6 months
Secondary outcomes (2)
The improvement of intestinal microflora imbalance
Measured: Bacteroidetes abundances and composition of gut microbiota (baseline, 4 weeks, 8 weeks and 12 weeks)
The change of inflammatory markers
The effect on plasma levels of inflammatory markers, such as IL-1B, IL-6 and TNF-α(baseline, 12 weeks)
Measured: The change of inflammatory markers (baseline, 12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionOct 2017 (estimated)
- Study completionJan 2018 (estimated)
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.
- More trials run by Beijing Chao Yang 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Chao Yang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guang Wang, Beijing Chao Yang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02583438
- Sponsor's protocol ID
- Saxa015
- Status last verified
- Oct 2015
- First submitted
- 14 Oct 2015
- Last updated
- 22 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beijing Chao-yang Hospital, Capital Medical University
- ClinicalTrials.gov ID
- NCT02583438
- Acronym / sponsor ID
- Saxa015
- Conditions
- Type 2 Diabetes, Obesity
- Keywords
- Gut Microbiota, inflammatory marker, Glucose and lipid metabolism
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 22 Oct 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 intestinal microflora imbalance has been associated with obesity and type 2 diabetes. The researchers' study aimed to investigate the effect of saxagliptin on gut microbiota in patients with newly diagnosed type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lifestyle intervention | Experimental | Drug: Saxagliptin (Bristol-Myers Squibb Company) |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Females or males, and aged 20 to 65 years.
- Newly diagnosed type 2 diabetes
- HbA1C ≥7% and HbA1C <9%
Key exclusion criteria (10 listed)
- Hepatic insufficiency (ALT or AST> 1.5*ULN)
- Renal insufficiency [Creatinine clearance rate (Ccr)]<60ml/min estimated from MDRD equation)
- Coronary artery disease
- Thyroid disease
- Infectious 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 |
|---|---|---|
| Saxagliptin (Bristol-Myers Squibb Company)6-month treatment of Saxagliptin 5mg Qd | Drug | Lifestyle intervention |
Primary outcome
gut microbiota
Time frame: Change from Baseline Bacteroidetes abundances and composition of gut microbiota at 6 months
2 secondary outcomes
The improvement of intestinal microflora imbalance
Time frame: Bacteroidetes abundances and composition of gut microbiota (baseline, 4 weeks, 8 weeks and 12 weeks)
The change of inflammatory markers
Time frame: The change of inflammatory markers (baseline, 12 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Saxagliptin (Bristol-Myers Squibb Company) in people with Type 2 Diabetes and Obesity, run by Beijing Chao Yang Hospital.
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 3 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: status not confirmed, as of the sponsor's last update on 22 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
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 (time frame: Change from Baseline Bacteroidetes abundances and composition of gut microbiota at 6 months). 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 Oct 2015.