Incretin Based Therapy for Poorly Controlled Type 2 Diabetic Patients

Completed

• Conditions: Type 2 Diabetes Mellitus

• Registration Number: NCT02026024
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

Type 2 diabetes patients have been proved to have decreased of glucagon-like peptide-1 (GLP-1) levels. Incretin based therapy is associated with improved glycemic control by boosting GLP-1 levels . Nevertheless, the clinical effects are in great diversity for poorly controlled Type 2 diabetes patients. This study is designed to understand the pharmacological effects and genetic variation of incretin based therapy on type 2 diabetes.

Detailed Description

Background:

Since GLP-1 receptor is encoded by GLP1R ( glucagon-like peptide-1 receptor) gene, individuals may veritably respond to incretion based treatment, depending on the presence or absence of minor alleles characterized by single nucleotide polymorphisms. The genotyping of patients will be performed to compare the genetic factors and the pharmacological effects.

Expected Results: How to select a anti-diabetic drug tailored to the individual becomes more and more important because the enormously increasing classes of treatment modality. This study could be of great help in recommending the best possible agent for an individual, improving the possibility of treatment success, and justifying if the need of expensive drugs in a given patient.

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-12-30
• Study First Submitted QC: 2013-12-30
• Study First Posted: 2014-01-01
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-31
• Last Update Posted: 2016-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• i) Age > 20 years old ii)DM (diabetes mellitus) diagnosed > 2 years iii)HbA1c level of 8% to 12% iv) Receiving incretin based therapy at least one month (including either GLP-1 agonist or DPP(dipeptidyl peptidase)-IV inhibitor

Exclusion Criteria

• Type 1 Diabetes Mellitus

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
mean amplitude of glycaemic excursions (MAGE)	3 months

Trial Locations

Locations (1)

Chang Gung Memorial Hospital; 🇨🇳 Taoyuan, Taiwan