Evaluation of Glycemic Control after Sulfonylurea Withdrawal in Type 2 Diabetic Patients Treated with Combination of Oral Hypoglycemic Agents and Insuli

Phase 4

Completed

• Conditions: Type 2 diabetes; Insulin, sulfonylurea withdrawal, diabetic patients

• Registration Number: TCTR20130422001
• Lead Sponsor: Routine to Research Unit Siriraj Hospital (R2R)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2010-06-09
• Study Start: 2013-04-22
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Type 2 diabetic patients, 30 to 75 year-old, who were treated with insulin in combination with SU, were enrolled in the study. All the subjects have been treated with insulin for at least 3 years and SU at half of the maximum doses or higher. All subjects had hemoglobin A1C levels (HbA1c) of less than 8.5% and stable insulin dosage (less than 10% adjustment) for at least three months prior to the enrollment. Patients who received metformin were included in the study

Exclusion Criteria

Patients were excluded if they had other types of diabetes, received treatment with a combination of SU and once-daily insulin, or received thiazolidinediones or other medications which interfered with glucose or lipid metabolism. Other exclusion criteria included history of clinically significant heart disease (New York Heart Association Functional Classification greater than class II or abnormalities other than non-specific ST-T wave changes on the EKG), peripheral vascular disease, pulmonary disease, impaired renal function, poor blood pressure control, electrolyte abnormalities, and neuromuscular diseases.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Glycemic control 8 wk HbA1c/ Blood sugar

Secondary Outcome Measures

Name	Time	Method
Insulin secretion 2 week Oral glucose tolerance test