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Phase 4 Completed N=119 Treatment

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

Source: ClinicalTrials.gov NCT03108521 ↗
Enrolled (actual)
119
Serious AEs
0.0%
Results posted
Jul 2020
Primary outcomePrimary: Glycosylated Hemoglobin A1c (HbA1c) — 6.78 percentage of <HbA1c>
◆ Published Evidence
No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Glycosylated Hemoglobin A1c (HbA1c)
6.78
SECONDARY
Types of Gene Polymorphism
40.0; 29.2; 40.5; 24.3; 39.2; 25.0
SECONDARY
Change in Blood Glucose
-1.60; -2.18; -3.49; -3.45
SECONDARY
Change in Insulin
0.66; 4.00; 8.43; 2.99
SECONDARY
Change in C-peptide
0.03; 1.11

Eligibility Criteria

For Sitagliptin group--

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03108521). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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