Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00417729
Status:
COMPLETED
Last Update Posted:
2010-05-12
First Post:
2007-01-01
Brief Title:
Effects of Acarbose Versus Glibenclamide on MAGE and Oxidative Stress in Patients With Type 2 DM
Sponsor:
Taichung Veterans General Hospital
Organization:
Taichung Veterans General Hospital
Study Overview
Official Title:
Phase 4 Study Evaluation of the Effects of Acarbose Versus Glibenclamide on Mean Amplitude of Glycemic Excursions and Oxidative Stress in Patients With Type 2 Diabetes Insufficiently Controlled by Metformin
Status:
COMPLETED
Status Verified Date:
2010-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To compare effect of acarbose versus glibenclamide treatment on mean amplitude of glyclemic excursion and oxidative stress in diabetes individuals who failed to control their glucose by metformin therapy alone
Detailed Description:
This is a randomised and open-label study conducted in 2 medical centers in central part of Taiwan Type 2 diabetic outpatients were eligible if they were aged 30-70 years were on mono- or dual oral antidiabetic drugs for at least 3 months and had a glycated hemoglobin HbA1c value between 70 and 110 Patients who were treated with insulin or drugs that promote weight loss had impaired renal serum creatinine concentration greater than 1326 μmoll or liver AST or ALT 25 times upper limit of normal range function had a history of hemoglobinopathy or chronic anemia or women of child-bearing potential without adequate contraception were excluded All patients provided their informed consent before they were enrolled in this study
After an 8-week period of metformin monotherapy 500 mg tid all patients were randomised to add on either acarbose or glibenclamide The doses of acarbose and glibenclamide were 50 mg tid and 25 mg tid respectively for 4 weeks and force-titrated to 100 mg tid and 5 mg tid respectively for the last 12 weeks A complete 72 hours of glucose monitoring using a continuous glucose monitoring CGM system and meal tolerance test MTT after a 10-h overnight fasting were performed before randomisation and in the end of study Morning urine samples were collected for measurement of 8-iso prostaglandin F2α 8-iso PGF2α a commonly used parameter of oxidative stress 13-14 The primary objectives are the changes of MAGE obtained from CGM and urinary excretion rate of 8-iso PGF2α The secondary objectives include changes of HbA1c lipid profiles including total cholesterol low-density lipoprotein cholesterol LDL-C high-density lipoprotein cholesterol HDL-C and triglycerides oxidized low-density lipoprotein ox-LDL high-sensitivity C-reactive protein hs-CRP total adiponectin and high-molecular weight HMW adiponectin
After an 8-week period of metformin monotherapy 500 mg tid all patients were randomised to add on either acarbose or glibenclamide The doses of acarbose and glibenclamide were 50 mg tid and 25 mg tid respectively for 4 weeks and force-titrated to 100 mg tid and 5 mg tid respectively for the last 12 weeks A complete 72 hours of glucose monitoring using a continuous glucose monitoring CGM system and meal tolerance test MTT after a 10-h overnight fasting were performed before randomisation and in the end of study Morning urine samples were collected for measurement of 8-iso prostaglandin F2α 8-iso PGF2α a commonly used parameter of oxidative stress 13-14 The primary objectives are the changes of MAGE obtained from CGM and urinary excretion rate of 8-iso PGF2α The secondary objectives include changes of HbA1c lipid profiles including total cholesterol low-density lipoprotein cholesterol LDL-C high-density lipoprotein cholesterol HDL-C and triglycerides oxidized low-density lipoprotein ox-LDL high-sensitivity C-reactive protein hs-CRP total adiponectin and high-molecular weight HMW adiponectin
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None