PrediabetesPhase 4NCT01960205
Effect of Saxagliptin on Pre-Diabetes Mellitus and Obesity
A Phase 4 study testing Saxagliptin, metformin and lifestyle intervention in people with Prediabetes, run by Shandong Provincial Hospital at 1 site in China.
Trial summary
The purpose of the study is to examine the effect of Saxagliptin in the newly diagnosed people with pre-diabetes and obesity besides lifestyle intervention ,there to evaluate DPP 4 inhibitors of reversing pre-diabetes curative effect to normal blood sugar, and observe its influences on the targets of obesity related… Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Prediabetes
- What is being tested?
- Saxagliptin, metformin and lifestyle intervention
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Aug 2013to Dec 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.Newly diagnosed insulin resistance or glucose intolerance .
- 2.20 to 70 years of age.
- 3.BMI≥28kg/m2，or BMI>25kg/m2 beside waistline≥80cm（female)，≥90cm(male).
Who cannot join
- Under Diabetes Mellitus treatment.
- Allergy to dipeptidyl peptidase 4 (DPP-4) inhibitors .
- Active heart failure.
- Unwilling or unable to sign inform consents.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shandong Provincial Hospital
Jinan, Shandong, 250021
Xinli Zhou, MD, PhD, 15168889976, zhouxinli0301@163.com
Xinli Zhou, MD,PhD
About this study
Official title: Effect of Saxagliptin on Body Fat , Glucose and Beta Cell Function in Patients With Newly Diagnosed Pre-Diabetes Mellitus and Obesity
The purpose of the study is to examine the effect of Saxagliptin in the newly diagnosed people with pre-diabetes and obesity besides lifestyle intervention ,there to evaluate DPP 4 inhibitors of reversing pre-diabetes curative effect to normal blood sugar, and observe its influences on the targets of obesity related metabolic abnormalities, to explore new ways for intervention on populations with pre-diabetes and obesity .
Read the detailed description
Materials and Methods: This is a perspectiveness ,randomized, opening study, patients will be randomly assigned to the standarddose Saxagliptin group ,the lifestyle intervention group,the Metformin group and the low dose Saxagliptin group with a 6-month treatment period.
Oral glucose tolerance test will examined before and 6 months post-treatment during the trial.
- Conditions
- Prediabetes
- Being tested
- Saxagliptin, metformin, lifestyle intervention
- Keywords
- Saxagliptin, prediabetes, glucose intolerance,obesity
- Medical subject headings
- Prediabetic State, Glucose Intolerance, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SaxagliptinDrug
Also called Onglyza
5mg a day for 6 months
saxagliptinDrug
Also called Onglyza
2.5 mg a day for 6 months
metforminDrug
Also called melbine
500mg three times a day for 6 months
lifestyle interventionOther
Also called living way intervention
lifestyle intervention for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Standarddose Saxagliptin | Experimental | Saxagliptin 5 mg (tablet) ,5mg a day and lifestyle intervention for 6 months Receives: Drug: Saxagliptin |
| Lifestyle intervention | Active comparator | Lifestyle intervention for 6 months Receives: Other: lifestyle intervention |
| Metformin | Active comparator | Metformin 500 mg (tablet) ,500mg three times a day and lifestyle intervention for 6 months Receives: Drug: metformin |
| low dose Saxagliptin | Experimental | Saxagliptin 5 mg (tablet) ,2.5 mg a day and lifestyle intervention for 6 months Receives: Drug: saxagliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
oral glucose tolerance test
Measured: Change of Blood sugar from baseline at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2013 (estimated)
- Study startAug 2013
- Primary completionDec 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 PrediabetesStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Provincial Hospital
- Sponsor type
- Other government
- Collaborators
- Chinese Medical Association
- Responsible party
- Principal investigator, Xinli Zhou，MD，PHD, Shandong Provincial Hospital
- Investigators
- Xinli Zhou, MD, PhD, Principal investigator, Shandong Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01960205
- Sponsor's protocol ID
- ZXL-201308
- Status last verified
- Sep 2014
- First submitted
- 7 Oct 2013
- Last updated
- 25 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wang Z, Xu D, Huang L, Zhang T, Wang J, Chen Q, Kong L, Zhou X. Effects of saxagliptin on glucose homeostasis and body composition of obese patients with newly diagnosed pre-diabetes. Diabetes Res Clin Pract. 2017 Aug;130:77-85. doi: 10.1016/j.diabres.2017.05.012. Epub 2017 May 12.
PubMed 28575729
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Saxagliptin on Body Fat , Glucose and Beta Cell Function in Patients With Newly Diagnosed Pre-Diabetes Mellitus and Obesity
- ClinicalTrials.gov ID
- NCT01960205
- Acronym / sponsor ID
- ZXL-201308
- Conditions
- Prediabetes
- Keywords
- Saxagliptin, prediabetes, glucose intolerance,obesity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Shandong Provincial HospitalOther government
- Collaborators
- Chinese Medical Association
- Study start
- Aug 2013
- Primary completion
- Dec 2014 (estimated)
- First posted
- 10 Oct 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.
The purpose of the study is to examine the effect of Saxagliptin in the newly diagnosed people with pre-diabetes and obesity besides lifestyle intervention ,there to evaluate DPP 4 inhibitors of reversing pre-diabetes curative effect to normal blood sugar, and observe its influences on the targets of obesity related metabolic abnormalities, to explore new ways for intervention on populations with pre-diabetes and obesity .
Detailed description
Materials and Methods: This is a perspectiveness ,randomized, opening study, patients will be randomly assigned to the standarddose Saxagliptin group ,the lifestyle intervention group,the Metformin group and the low dose Saxagliptin group with a 6-month treatment period.
Oral glucose tolerance test will examined before and 6 months post-treatment during the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Standarddose Saxagliptin | Experimental | Drug: SaxagliptinSaxagliptin 5 mg (tablet) ,5mg a day and lifestyle intervention for 6 months |
| Lifestyle intervention | Active comparator | Other: lifestyle interventionLifestyle intervention for 6 months |
| Metformin | Active comparator | Drug: metforminMetformin 500 mg (tablet) ,500mg three times a day and lifestyle intervention for 6 months |
| low dose Saxagliptin | Experimental | Drug: saxagliptinSaxagliptin 5 mg (tablet) ,2.5 mg a day and lifestyle intervention for 6 months |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1.Newly diagnosed insulin resistance or glucose intolerance .
- 2.20 to 70 years of age.
- 3.BMI≥28kg/m2，or BMI>25kg/m2 beside waistline≥80cm（female)，≥90cm(male).
Key exclusion criteria (4 listed)
- Under Diabetes Mellitus treatment.
- Allergy to dipeptidyl peptidase 4 (DPP-4) inhibitors .
- Active heart failure.
- Unwilling or unable to sign inform consents.
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 |
|---|---|---|
| SaxagliptinAlso: Onglyza5mg a day for 6 months | Drug | Standarddose Saxagliptin |
| saxagliptinAlso: Onglyza2.5 mg a day for 6 months | Drug | low dose Saxagliptin |
| metforminAlso: melbine500mg three times a day for 6 months | Drug | Metformin |
| lifestyle interventionAlso: living way interventionlifestyle intervention for 6 months | Other | Lifestyle intervention |
Primary outcome
oral glucose tolerance test
Time frame: Change of Blood sugar from baseline at 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2014.
- Derived from this study: PubMed 28575729Wang Z, Xu D, Huang L, Zhang T, Wang J, Chen Q, Kong L, Zhou X. Effects of saxagliptin on glucose homeostasis and body composition of obese patients with newly diagnosed pre-diabetes. Diabetes Res Clin Pract. 2017 Aug;130:77-85. doi: 10.1016/j.diabres.2017.05.012. Epub 2017 May 12.
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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.
Xinli Zhou, MD, PhD principal investigator
Shandong Provincial Hospital
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 Saxagliptin, metformin and lifestyle intervention in people with Prediabetes, run by Shandong Provincial 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 3 inclusion and 4 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 25 Sep 2014. 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 Xinli Zhou, MD,PhD (15168889976, zhouxinli0301@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oral glucose tolerance test (time frame: Change of Blood sugar from baseline at 6 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 NCT01960205, 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 25 Sep 2014.