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

NCT03108521 | Completed Phase 4 Results DMC

• 1 other identifier: 2015SZ0182
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus

Keywords

DPP-4; GLP1R ; gene polymorphism research; diabetes

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks later

Secondary Outcomes (4)

• Types of Gene Polymorphism

  Baseline

• Change in Blood Glucose

  Basline and 12 weeks later. Fasting, 0.5h, 2h,3h after take 75g glucose orally.

• Change in Insulin

  Basline and 12 weeks later. Fasting and 0.5h, 2h,3h after take 75g glucose orally.

• Change in C-peptide

  Basline and 12 weeks later. Fasting and 2h after take 75g glucose orally.

Study Arms (2)

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.

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.

Interventions

Sitagliptin DRUG

100mg.QD for 3 months

Also known as: Januvia

Sitagliptin group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Sichuan Provincial People's Hospital: lead

Study Sites (1)

Sichuan provincial people's hospital

Chengdu, Sichuan, 610000, China

Location

Related Publications (3)

• 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.

  PMID: 25962518 BACKGROUND

• 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.

  PMID: 24353270 BACKGROUND

• 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.

  PMID: 24140094 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

Results Point of Contact

• Title: Dr. Xingwei Wu and Professor Enwu Long
• Organization: Department of Pharmacy, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital

wuxw1988@126.com

+8615928017367

Study Officials

• Enwu Long, Master

  Director of Pharmacy department

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Pharmacist

Study Record Dates

• First Submitted: January 4, 2017
• First Posted: April 11, 2017
• Study Start: April 21, 2016
• Primary Completion: January 4, 2018
• Study Completion: October 8, 2018
• Last Updated: July 30, 2020
• Results First Posted: July 30, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)