Diabetes MellitusPhase 4NCT03108521

SNP Study of DPP-4 and GLP-1R in Chinese People (Including Diabetes Patients)

A Phase 4 study testing Sitagliptin in people with Diabetes Mellitus, run by Sichuan Provincial People's Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Diabetes Mellitus
What is being tested?: Sitagliptin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 119 participants
Where: 1 siteChina
Study dates: 21 Apr 2016to 8 Oct 2018
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

According to diagnostic criteria from Chinese type 2 diabetes prevention and treatment guidelines in diabetes, that published in the Chinese Medical Association Diabetes credits in 2010: Symptoms of diabetes (polydipsia, polyphagia, polyuria, weight loss, itchy skin, blurred vision and other acute metabolic disorders performance caused by hyperglycemia) and RBG≥11.1mmol/L, or fasting plasma glucose (FPG)≥7.0mmol/L, or plasma glucose of 2 hours post glucose-load≥11.1 and patients diagnosed with type 2 diabetes; HbA1c in the range of 7%-10%;
Age 40-70 years;
Body Mass Index(BMI) 18-40;
Did not accepted any antihyperglycemic therapies during the past 4 weeks, or did not change their antihyperglycemic treatment plan in the past 3 months;
Did not participate in clinical trials within three months;
No serious heart, brain, liver and kidney disease;
Signed informed consent.

Who cannot join

Have taken any incretin drugs within recent 1 month;
Patients with a weakened immune system;
C-peptide < 0.3ng/ml;
GLP-1 and DPP4-i drugs allergies;
Pregnancy and breast-feeding patients;
Patients taking drugs that may affect the metabolism of GLP-1 and DPP4;

Show all 10Show fewer

Patients have serious heart, liver, kidney and respiratory dysfunction; Patients have medullary thyroid carcinoma (MTC) with past history or family history, as well as multiple endocrine neoplasia type 2 syndrome (MEN2);
Drug abusing and alcoholism within a year.
For non-T2D group--
No major diseases such as tumors, no dyslipidemia, chronic diseases such as hypertension, and non-diabetic patients whose blood sugar and glycated hemoglobin values cannot meet the criteria for diagnosis of T2DM, and the age is over 50 years old.

Trial locations and contacts

1 site in 1 country.

China1 site

Sichuan provincial people's hospital
Chengdu, Sichuan, 610000

Other trials in China

About this study

Official title: Study on Polymorphism of DPP-4 and GLP-1R Genes in Chinese Population and Its Empirical Study on Treatment of Diabetes

Incretin-based therapy is currently one of the most popular diabetes treatment approaches. However, differences of response ware found in previous studies. We hypothesis that SNPs of DPP-4, GLP-1 and GLP-1R genes may play crucial roles in the response differences. Therefore, this study aims to investigate the correlation of incretin-related gene polymorphism and individual differences in the response of DPP-4 inhibators (take Sitagliptin as an example). In addition, The distribution differences of the SNPs in diabetics and non-diabetics are evaluated to study the relationships between the SNPs and diabetes onsets.

Read the detailed description

Single Nucleotide Polymorphism (SNP) plays an important role in the differences of clinical manifestations and drug responses of diseases. The vast majority of SNP sites are located in the non-coding region of the gene (about 95%), which is called SNP(non-coding SNP (ncSNP), while the other part of SNP is located in the coding region of the gene, which is called coding SNP (cSNP). Furthermore, cSNP can be divided into two categories: SNP that does not change the encoded amino acid sequence is called synonymous SNP(synonymous SNP, SSNP); SNP that changes amino acid sequence is called SNP(non-synonymous SNP (NSNP). Although not involved in coding amino acid, some ncSNPs may also affect the regulation of protein expression. Therefore, it is of great significance to study the effects of NC SNP and cSNP on the occurrence and development of diseases and drugs.

DPP-4 enzyme inhibitor is combined with DPP-4 enzyme in human body to reduce hydrolysis of active GLP-1, thus increasing the level of endogenous active GLP-1. Active GLP-1 combines with its receptor GLP-1R to promote insulin release and inhibit glucagon release in hyperglycemia state, and produces opposite effect in hypoglycemia state.

Based on the above principles, we speculate that SNP of genes that may affect the hypoglycemic effect of DPP-4 enzyme inhibitor are:

SNP of DPP-4 enzyme gene. SNP of DPP-4 enzyme gene may affect the enzyme activity and/or protein expression level of DPP-4. Assuming that the effect of DPP-4 enzyme inhibitor is sufficient, patients with higher DPP-4 enzyme activity are more sensitive to DPP-4 enzyme inhibitor drugs; However, for patients with low DPP-4 enzyme activity, DPP-4 enzyme inhibitor drugs cannot play a stronger role in lowering blood sugar.
SNP of GLP-1 gene. SNP of GLP-1 gene may affect activity or expression level of GLP-1. Patients with high GLP-1 level are more sensitive to DPP-4 enzyme inhibitor drugs.
SNP of GLP-1R gene. SNP of GLP-1R gene may affect activity or expression level of GLP-1R. Patients with high GLP-1R level are also more susceptible to DPP-4 enzyme inhibitor drugs.

However, studies on the hypoglycemic effect of DPP-4, GLP-1 and their receptors on DPP-4 enzyme inhibitors in the treatment of T2DM are rare, which is not conducive to the evaluation of individualized treatment of such drugs. Therefore, this chapter intends to select SNP sites with high mutation frequencies of DPP-4, GLP-1 and GLP-1R genes to study the mutation frequencies of these SNPs in diabetic patients and non-diabetic patients and their effects on DPP-4 enzyme inhibitor sitagliptin's hypoglycemic effect on T2DM patients.

Conditions: Diabetes Mellitus
Being tested: Sitagliptin
Keywords: DPP-4; GLP1R ; gene polymorphism research; diabetes
Medical subject headings: Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SitagliptinDrug
Also called Januvia
100mg.QD for 3 months

Study groups in NCT03108521
Study group	Role	What they receive
Sitagliptin group	Experimental	Patients in this group will accept Sitagliptin phosphate tablets as their intervention. Specifications: Each tablet 100mg (with sitagliptin dollars). Regimen: The recommended dose is 100mg.QD for 3 months. Receives: Drug: Sitagliptin
non-T2DM group	No intervention	Subjects in this group are T2D free. We use their gene information to study SNP differences between T2D patients and non-T2DM people.

What is being measured

The primary outcome is the main question the study is designed to answer.

Glycosylated Hemoglobin A1c (HbA1c)
non-T2D subjects only tested HbA1c at baseline. Of the 71 patients who completed the study, 69 collected HbA1c at both baseline and study endpoint, and 2 subjects did not carry out HbA1c measurement for personal reasons.
Measured: 12 weeks later

Secondary outcomes (4)

Types of Gene Polymorphism
24 SNPs genetic points of DPP-4, GLP-1 and GLP-1R.
Measured: Baseline
Change in Blood Glucose
Fasting Blood glucose, the postprandial 0.5-hour,2-hour,3-hour blood glucose were measured at baseline and at study end points, and the difference between baseline and study end points were compared.Participants in "Non-T2DM Group" were not taking Sitagliptin, so their blood glucose were not measured.
Measured: Basline and 12 weeks later. Fasting, 0.5h, 2h,3h after take 75g glucose orally.
Change in Insulin
Fasting insulin, the postprandial 0.5-hour,2-hour,3-hour insulin were measured at baseline and at study end points, and the difference between baseline and study end points were compared.The changes in fasting insulin, the postprandial 0.5-hour,2-hour,3-hour insulin were compared among patients with different genotypes at baseline and at study end points.Participants in "Non-T2DM Group" were not taking Sitagliptin, so their insulin were not measured.
Measured: Basline and 12 weeks later. Fasting and 0.5h, 2h,3h after take 75g glucose orally.
Change in C-peptide
Fasting C-peptide, the postprandial 2-hour C-peptide were measured at baseline and at study end points, and the difference between baseline and study end points were compared.The changes in fasting C-peptide, the postprandial 2-hour C-peptide were compared among patients with different genotypes at baseline and at study end points.Participants in "Non-T2DM Group" were not taking Sitagliptin, so their C-peptide were not measured.
Measured: Basline and 12 weeks later. Fasting and 2h after take 75g glucose orally.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Apr 20168 Oct 2018

First posted11 Apr 2017
Study start21 Apr 2016
Primary completion4 Jan 2018
Study completion8 Oct 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Diabetes MellitusStudies 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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 119 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03108521
Sponsor's protocol ID: 2015SZ0182
Status last verified: Jul 2020
First submitted: 4 Jan 2017
Last updated: 30 Jul 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Holman N, Young B, Gadsby R. Current prevalence of Type 1 and Type 2 diabetes in adults and children in the UK. Diabet Med. 2015 Sep;32(9):1119-20. doi: 10.1111/dme.12791. No abstract available.
PubMed 25962518
Palermo A, Maggi D, Maurizi AR, Pozzilli P, Buzzetti R. Prevention of type 2 diabetes mellitus: is it feasible? Diabetes Metab Res Rev. 2014 Mar;30 Suppl 1:4-12. doi: 10.1002/dmrr.2513.
PubMed 24353270
Lee YS, Jun HS. Anti-diabetic actions of glucagon-like peptide-1 on pancreatic beta-cells. Metabolism. 2014 Jan;63(1):9-19. doi: 10.1016/j.metabol.2013.09.010. Epub 2013 Oct 17.
PubMed 24140094

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study on Polymorphism of DPP-4 and GLP-1R Genes in Chinese Population and Its Empirical Study on Treatment of Diabetes
ClinicalTrials.gov ID: NCT03108521
Acronym / sponsor ID: 2015SZ0182
Conditions: Diabetes Mellitus
Keywords: DPP-4; GLP1R ; gene polymorphism research; diabetes
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 119 participants (actual)
Lead sponsor: Sichuan Provincial People's HospitalUniversity, hospital or other
Study start: 21 Apr 2016 (actual)
Primary completion: 4 Jan 2018 (actual)
Study completion: 8 Oct 2018 (actual)
First posted: 11 Apr 2017 (actual)
Results: Posted 30 Jul 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Based on the above principles, we speculate that SNP of genes that may affect the hypoglycemic effect of DPP-4 enzyme inhibitor are:

SNP of DPP-4 enzyme gene. SNP of DPP-4 enzyme gene may affect the enzyme activity and/or protein expression level of DPP-4. Assuming that the effect of DPP-4 enzyme inhibitor is sufficient, patients with higher DPP-4 enzyme activity are more sensitive to DPP-4 enzyme inhibitor drugs; However, for patients with low DPP-4 enzyme activity, DPP-4 enzyme inhibitor drugs cannot play a stronger role in lowering blood sugar.
SNP of GLP-1 gene. SNP of GLP-1 gene may affect activity or expression level of GLP-1. Patients with high GLP-1 level are more sensitive to DPP-4 enzyme inhibitor drugs.
SNP of GLP-1R gene. SNP of GLP-1R gene may affect activity or expression level of GLP-1R. Patients with high GLP-1R level are also more susceptible to DPP-4 enzyme inhibitor drugs.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Sitagliptin group	Experimental	Drug: SitagliptinPatients in this group will accept Sitagliptin phosphate tablets as their intervention. Specifications: Each tablet 100mg (with sitagliptin dollars). Regimen: The recommended dose is 100mg.QD for 3 months.
non-T2DM group	No intervention	–Subjects in this group are T2D free. We use their gene information to study SNP differences between T2D patients and non-T2DM people.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

According to diagnostic criteria from Chinese type 2 diabetes prevention and treatment guidelines in diabetes, that published in the Chinese Medical Association Diabetes credits in 2010: Symptoms of diabetes (polydipsia, polyphagia, polyuria, weight loss, itchy skin, blurred vision and other acute metabolic disorders performance caused by hyperglycemia) and RBG≥11.1mmol/L, or fasting plasma glucose (FPG)≥7.0mmol/L, or plasma glucose of 2 hours post glucose-load≥11.1 and patients diagnosed with type 2 diabetes; HbA1c in the range of 7%-10%;
Age 40-70 years;
Body Mass Index(BMI) 18-40;
Did not accepted any antihyperglycemic therapies during the past 4 weeks, or did not change their antihyperglycemic treatment plan in the past 3 months;
Did not participate in clinical trials within three months;

Key exclusion criteria (10 listed)

Have taken any incretin drugs within recent 1 month;
Patients with a weakened immune system;
C-peptide < 0.3ng/ml;
GLP-1 and DPP4-i drugs allergies;
Pregnancy and breast-feeding patients;

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
SitagliptinAlso: Januvia100mg.QD for 3 months	Drug	Sitagliptin group

Primary outcome

Glycosylated Hemoglobin A1c (HbA1c)
Time frame: 12 weeks later
non-T2D subjects only tested HbA1c at baseline. Of the 71 patients who completed the study, 69 collected HbA1c at both baseline and study endpoint, and 2 subjects did not carry out HbA1c measurement for personal reasons.

4 secondary outcomes

Types of Gene Polymorphism
Time frame: Baseline
Change in Blood Glucose
Time frame: Basline and 12 weeks later. Fasting, 0.5h, 2h,3h after take 75g glucose orally.
Change in Insulin
Time frame: Basline and 12 weeks later. Fasting and 0.5h, 2h,3h after take 75g glucose orally.
Change in C-peptide
Time frame: Basline and 12 weeks later. Fasting and 2h after take 75g glucose orally.

Results and safety

Results posted to the registry on 30 Jul 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sitagliptin Group	83	71
Non-T2D Group	36	36

Primary outcome: Glycosylated Hemoglobin A1c (HbA1c)

Time frame: 12 weeks later. Mean (Standard Deviation). Unit: percentage of <HbA1c>

Measure	Sitagliptin Group n = 69
Value	6.78 (0.82)

Population analysed: non-T2D subjects only tested HbA1c at baseline. Of the 71 patients who completed the study, 69 collected HbA1c at both baseline and study endpoint, and 2 subjects did not carry out HbA1c measurement for personal reasons.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 3 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sitagliptin Group	0 of 71 (0%)	12 of 71 (16.9%)	0 of 71
Non-T2DM Group	0 of 36 (0%)	0 of 36 (0%)	0 of 36

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 25962518Holman N, Young B, Gadsby R. Current prevalence of Type 1 and Type 2 diabetes in adults and children in the UK. Diabet Med. 2015 Sep;32(9):1119-20. doi: 10.1111/dme.12791. No abstract available.
Background: PubMed 24353270Palermo A, Maggi D, Maurizi AR, Pozzilli P, Buzzetti R. Prevention of type 2 diabetes mellitus: is it feasible? Diabetes Metab Res Rev. 2014 Mar;30 Suppl 1:4-12. doi: 10.1002/dmrr.2513.
Background: PubMed 24140094Lee YS, Jun HS. Anti-diabetic actions of glucagon-like peptide-1 on pancreatic beta-cells. Metabolism. 2014 Jan;63(1):9-19. doi: 10.1016/j.metabol.2013.09.010. Epub 2013 Oct 17.
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.

Enwu Long, Master principal investigator

Director of Pharmacy department

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 Sitagliptin in people with Diabetes Mellitus, run by Sichuan Provincial People's 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 7 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: finished, as of the sponsor's last update on 30 Jul 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?

Yes. Results are posted in the registry (first posted 30 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Glycosylated Hemoglobin A1c (HbA1c) (time frame: 12 weeks later). 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 NCT03108521, which also lists 3 linked publications.

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 30 Jul 2020.