R230C and C230C Variants of ABCA1 and Glyburide Response

Type 2 Diabetes Clinical Trial

Official title: Effect of the R230C Variant of the ATP-binding Cassette Transporter A1 (ABCA1) Gene on the Response to Treatment With Glibenclamide in Patients With Type 2 Diabetes Mellitus

Status Completed

Clinical Trial Summary

The objective of the study is to know if the R230C and C230C variants of the ATP-binding cassette transporter A1 (ABCA1) gene are associated with a smaller glucose lowering effect compared to the wild type allele (R230R) in patients with type 2 diabetes.

Clinical Trial Description

Specific objectives:

1. In patients with type 2 diabetes stratified by the existence of the risk alleles (R230C/C230C) or the wild variant (R230R) of ABC-A1, compare the changes resulting from the treatment with glibenclamide on following continuous variables:

• Fasting glucose

• Percentage reduction

• Hemoglobin A1c,

• Cholesterol, triglycerides, HDL cholesterol, LDL cholesterol

• Weight

2. In patients with type 2 diabetes stratified by the existence of the risk alleles (R230C/C230C) or the wild variant (R230R) of ABC-A1, compare the changes resulting from the treatment with glibenclamide on following binomial variables:

• Number of cases that reach fasting plasma glucose lower than 110 mg/dl

• Number of cases that reach an HbA1c less than 7% ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

• NCT number: NCT01456650
• Study type: Interventional
• Source: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Status: Completed
• Phase: Phase 4
• Start date: March 2011
• Completion date: December 2012