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Report for Clinical Trial NCT03108521

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Sichuan Provincial People's Hospital

With the development of pharmacogenomics and pharmacogenetics, personalized medicine based on genetic are increasingly required clinically. Incretin-based therapy is currently the most popular diabetes treatment. This study mainly research the correlation of incretin-related gene polymorphism and individual differences in the response of these drugs from the following four aspects. 1. . To study Chinese human gene polymorphism's mutation frequency and allele frequency, by screening Chinese people gene polymorphisms which affecting DPP-4 enzymatic activity. 2. . To study the mutation frequency of DPP-4 mutation site(rs12469968, rs3788979, rs2284872, rs7565794) and GLP1R mutation site(rs3765467) in Chinese population. 3. . By collecting clinical parameters and efficacy indicators to reveal the relationship between Chinese DPP-4 gene and GLP1R gene polymorphism on the clinical manifestations and drug response. This study will be improved based on actual experimental research methods, and design intervening measures for Chinese people, to explore the dose-effect relationship of DPP-4 and GLP1R gene polymorphism in the treatment of diabetes in Chinese population. 4. . Incretins is a new generation hypoglycemic agent. By studying gene polymorphism and drug response, to research how to plan treatment for clinical diabetes with DPP-4 and GLP1R gene polymorphism. Provide the basis for individualized treatment of these drugs.

NCT03108521 Diabetes Mellitus

2 Interventions

Name: Sitagliptin

Description: Januvia

Type: Drug

Sitagliptin group

Name: Liraglutide

Type: Drug

Liraglutide group


Primary Outcomes

Measure: Glycated albumin

Time: Change from Baseline Glycated albumin at 4 weeks (Liraglutide group)

Description: 28 SNP genetic points of DPP-4 and GLP1R

Measure: SNP mutation type

Time: Baseline

Measure: Glycosylated hemoglobin (HbA1c)

Time: Change from Baseline HbA1c at 12 weeks (Sitagliptin group)

Measure: Blood glucose

Time: Change from fasting, 0.5h, 2h,3h after take 75g glucose orally of Baseline Blood Glucose at 12weeks (Sitagliptin group) or 4 weeks (Liraglutide group)

Measure: Insulin

Time: Change from fasting and after take 75g glucose orally 0.5h, 2h,3h of Baseline Blood Insulin at 12weeks (Sitagliptin group) or 4 weeks (Liraglutide group)

Measure: C-peptide

Time: Change from fasting and 2h after take 75g glucose orally of Baseline C-peptide at 12weeks (Sitagliptin group) or 4 weeks (Liraglutide group)

Secondary Outcomes

Measure: Total cholesterol

Time: Change from Baseline Total cholesterol at 12 weeks (Sitagliptin group) or 4 weeks (Liraglutide group)

Measure: Triglyceride

Time: Change from Baseline Triglyceride at 12 weeks (Sitagliptin group) or 4 weeks (Liraglutide group)

Measure: Low density lipoprotein

Time: Change from Baseline Low density lipoprotein at 12 weeks (Sitagliptin group) or 4 weeks (Liraglutide group)

Purpose: Treatment

Allocation: Randomized

Single Group Assignment


There are 5 SNPs

SNPs


1 rs12469968

To study the mutation frequency of DPP-4 mutation site(rs12469968, rs3788979, rs2284872, rs7565794) and GLP1R mutation site(rs3765467) in Chinese population.


2 rs2284872

To study the mutation frequency of DPP-4 mutation site(rs12469968, rs3788979, rs2284872, rs7565794) and GLP1R mutation site(rs3765467) in Chinese population.


3 rs3765467

To study the mutation frequency of DPP-4 mutation site(rs12469968, rs3788979, rs2284872, rs7565794) and GLP1R mutation site(rs3765467) in Chinese population.


4 rs3788979

To study the mutation frequency of DPP-4 mutation site(rs12469968, rs3788979, rs2284872, rs7565794) and GLP1R mutation site(rs3765467) in Chinese population.


5 rs7565794

To study the mutation frequency of DPP-4 mutation site(rs12469968, rs3788979, rs2284872, rs7565794) and GLP1R mutation site(rs3765467) in Chinese population.



HPO Nodes