Trial Outcomes & Findings for SNP Study of DPP-4 and GLP-1R in Chinese People (Including Diabetes Patients) (NCT NCT03108521)

Last Updated: 2020-07-30

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

119 participants

Primary outcome timeframe

12 weeks later

Results posted on

2020-07-30

Participant Flow

All subjects ware recruited in medical clinic of Sichuan Provincial People's Hospital during July 26th 2016 to October 12th 2017.

Participant milestones

Participant milestones
Measure	Sitagliptin Group 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. Sitagliptin: 100mg.QD for 3 months	Non-T2D Group Aims to study correlationship between SNP and T2DM onset.
Overall Study STARTED	83	36
Overall Study COMPLETED	71	36
Overall Study NOT COMPLETED	12	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Sitagliptin Group 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. Sitagliptin: 100mg.QD for 3 months	Non-T2D Group Aims to study correlationship between SNP and T2DM onset.
Overall Study Lost to Follow-up	3	0
Overall Study Lack of Efficacy	2	0
Overall Study Physician Decision	4	0
Overall Study Adverse Event	3	0

Baseline Characteristics

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sitagliptin Group n=83 Participants 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. Sitagliptin: 100mg.QD for 3 months	Non-T2DM Group n=36 Participants Subjects in this group are T2D free. We use their gene information to study SNP differences between T2D patients and non-T2DM people.	Total n=119 Participants Total of all reporting groups
Age, Continuous	54.0 years STANDARD_DEVIATION 9.7 • n=83 Participants	60.6 years STANDARD_DEVIATION 7.26 • n=36 Participants	57.1 years STANDARD_DEVIATION 7.9 • n=119 Participants
Sex: Female, Male Female	28 Participants n=83 Participants	16 Participants n=36 Participants	44 Participants n=119 Participants
Sex: Female, Male Male	55 Participants n=83 Participants	20 Participants n=36 Participants	75 Participants n=119 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=83 Participants	0 Participants n=36 Participants	0 Participants n=119 Participants
Race (NIH/OMB) Asian	83 Participants n=83 Participants	36 Participants n=36 Participants	119 Participants n=119 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=83 Participants	0 Participants n=36 Participants	0 Participants n=119 Participants
Race (NIH/OMB) Black or African American	0 Participants n=83 Participants	0 Participants n=36 Participants	0 Participants n=119 Participants
Race (NIH/OMB) White	0 Participants n=83 Participants	0 Participants n=36 Participants	0 Participants n=119 Participants
Race (NIH/OMB) More than one race	0 Participants n=83 Participants	0 Participants n=36 Participants	0 Participants n=119 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=83 Participants	0 Participants n=36 Participants	0 Participants n=119 Participants
HbA1c	8.26 percentage of HbA1c STANDARD_DEVIATION 0.88 • n=69 Participants • 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.	5.01 percentage of HbA1c STANDARD_DEVIATION 0.67 • n=36 Participants • 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.	7.24 percentage of HbA1c STANDARD_DEVIATION 1.75 • n=105 Participants • 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.

PRIMARY outcome

Timeframe: 12 weeks later

Population: 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.

Outcome measures

Outcome measures
Measure	Sitagliptin Group n=69 Participants 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. Sitagliptin: 100mg.QD for 3 months	Non-T2DM Group Patients in this group also will detect the 24 SNPs genetic points of DPP-4, GLP-1 and GLP-1R.
Glycosylated Hemoglobin A1c (HbA1c)	6.78 percentage of <HbA1c> Standard Deviation 0.82	—

SECONDARY outcome

Timeframe: Baseline

Population: All of the participants were detected the 24 SNPs genetic points

24 SNPs genetic points of DPP-4, GLP-1 and GLP-1R.

Outcome measures

Outcome measures
Measure	Sitagliptin Group n=83 Participants 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. Sitagliptin: 100mg.QD for 3 months	Non-T2DM Group n=36 Participants Patients in this group also will detect the 24 SNPs genetic points of DPP-4, GLP-1 and GLP-1R.
Types of Gene Polymorphism rs7565794	40.0 percentage of Allele frequency	29.2 percentage of Allele frequency
Types of Gene Polymorphism rs10166311	40.5 percentage of Allele frequency	24.3 percentage of Allele frequency
Types of Gene Polymorphism rs2300757	39.2 percentage of Allele frequency	25.0 percentage of Allele frequency
Types of Gene Polymorphism rs2302873	42.4 percentage of Allele frequency	25.0 percentage of Allele frequency
Types of Gene Polymorphism rs2284872	42.4 percentage of Allele frequency	25.0 percentage of Allele frequency
Types of Gene Polymorphism rs7608798	44.2 percentage of Allele frequency	24.3 percentage of Allele frequency
Types of Gene Polymorphism rs2111850	40.5 percentage of Allele frequency	25 percentage of Allele frequency
Types of Gene Polymorphism rs16822665	42.5 percentage of Allele frequency	25.0 percentage of Allele frequency

SECONDARY outcome

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

Population: 71 patients complete the study

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.

Outcome measures

Outcome measures
Measure	Sitagliptin Group n=71 Participants 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. Sitagliptin: 100mg.QD for 3 months	Non-T2DM Group Patients in this group also will detect the 24 SNPs genetic points of DPP-4, GLP-1 and GLP-1R.
Change in Blood Glucose ΔFasting blood glucose	-1.60 mmol/l Standard Deviation 2.29	—
Change in Blood Glucose Δ0.5h Glucose	-2.18 mmol/l Standard Deviation 3.11	—
Change in Blood Glucose Δ2h Glucose	-3.49 mmol/l Standard Deviation 4.45	—
Change in Blood Glucose Δ3h Glucose	-3.45 mmol/l Standard Deviation 4.36	—

SECONDARY outcome

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

Population: 71 patients complete the study

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.

Outcome measures

Outcome measures
Measure	Sitagliptin Group n=71 Participants 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. Sitagliptin: 100mg.QD for 3 months	Non-T2DM Group Patients in this group also will detect the 24 SNPs genetic points of DPP-4, GLP-1 and GLP-1R.
Change in Insulin ΔFasting insulin	0.66 μU/ml Standard Deviation 4.36	—
Change in Insulin Δ0.5h insulin	4.00 μU/ml Standard Deviation 8.62	—
Change in Insulin Δ2h insulin	8.43 μU/ml Standard Deviation 13.00	—
Change in Insulin Δ3h insulin	2.99 μU/ml Standard Deviation 11.77	—

SECONDARY outcome

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

Population: 71 patients complete the study

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.

Outcome measures

Outcome measures
Measure	Sitagliptin Group n=71 Participants 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. Sitagliptin: 100mg.QD for 3 months	Non-T2DM Group Patients in this group also will detect the 24 SNPs genetic points of DPP-4, GLP-1 and GLP-1R.
Change in C-peptide ΔFasting C peptide	0.03 ng/ml Standard Deviation 0.41	—
Change in C-peptide Δ2h C peptide	1.11 ng/ml Standard Deviation 1.38	—

Adverse Events

Sitagliptin Group

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Non-T2DM Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Sitagliptin Group n=71 participants at risk 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. Sitagliptin: 100mg.QD for 3 months	Non-T2DM Group n=36 participants at risk Subjects in this group are T2D free. We use their gene information to study SNP differences between T2D patients and non-T2DM people.
Gastrointestinal disorders abdominal distension and abdominal pain 8 cases, dizziness 2 cases, constipation 2 cases	16.9% 12/71 • Number of events 12 • 3 months All-Cause Mortality, Serious, or Other (non-serious) Adverse Events were monitored/assessed, but no All-Cause Mortality or Serious Adverse Events observed during the study period.The dosage and administration of the drugs were not adjusted, and all adverse reactions improved after 3 days.	0.00% 0/36 • 3 months All-Cause Mortality, Serious, or Other (non-serious) Adverse Events were monitored/assessed, but no All-Cause Mortality or Serious Adverse Events observed during the study period.The dosage and administration of the drugs were not adjusted, and all adverse reactions improved after 3 days.

Additional Information

Dr. Xingwei Wu and Professor Enwu Long

Department of Pharmacy, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital

Phone: +8615928017367

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place