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Completed

NCT Number: NCT02026024

Incretin Based Therapy for Poorly Controlled Type 2 Diabetic Patients

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chang Gung Memorial Hospital

Taoyuan, Taiwan, 333

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. mean amplitude of glycaemic excursions (MAGE)

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

Clinical and Genetic Variations Study of Incretin Based Therapy for Poorly Controlled Type 2 Diabetic Patients

Acronym: IBCT2

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jan 1, 2014
Registry last updated
Feb 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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