A Phase 4 interventional study of Acarbose in Diabetes Mellitus, sponsored by Taichung Veterans General Hospital. Completed at 1 site in Taiwan. Open to participants aged 30 Years to 70 Years. Per ClinicalTrials.gov, last updated 2010-05-12.
Sponsored by Taichung Veterans General Hospital · Phase 4, Interventional, and Treatment
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
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 7.0% and 11.0%. Patients who were treated with insulin or drugs that promote weight loss, had impaired renal (serum creatinine concentration greater than 132.6 μmol/l) or liver (AST or ALT 2.5 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 t.i.d.), all patients were randomised to add on either acarbose or glibenclamide. The doses of acarbose and glibenclamide were 50 mg t.i.d. and 2.5 mg t.i.d., respectively, for 4 weeks and force-titrated to 100 mg t.i.d. and 5 mg t.i.d., 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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 51 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
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Patients may be included in the clinical trial only if they meet all of the following criteria:
Exclusion Criteria:
Patients will be excluded from the clinical trial for any of the following reasons:
acarbose vs. glibenclamide (background metformin therapy)
Drug: Acarbose
After an 8-week period of metformin monotherapy (500 mg t.i.d.), all patients were randomised to add on either acarbose or glibenclamide. The doses of acarbose and glibenclamide were 50 mg t.i.d. and 2.5 mg t.i.d., respectively, for 4 weeks and force-titrated to 100 mg t.i.d. and 5 mg t.i.d., respectively, for the last 12 weeks.
Also known as: glibenclamide
Mean Amplitude Glycemic Excursion
A Medtronic MiniMed Continuous Glucose Monitoring System (Northridge, CA) was used for continuous glucose measurements on an ambulatory basis for 72 consecutive hours and MAGE calculated from the dataset.
Time frame: before randomisation and end of study
Oxidative stress
Spot urine was collected for measurement of 8-iso PGF2 alpha excretion rate.
Time frame: before randomisation and end of study
HbA1c
Glycated hemoglobin for evaluation of efficacy of glycemic control.
Time frame: before randomisation and end of study
fasting glucose
after an overnight fasting
Time frame: before randomisation and end of study
Insulin response
Evaluation by meal tolerance test. Patients were asked to consume 1.5 cans of Ensure Liquid (266 kcal/can, caloric contribution: 64% carbohydrate, 14% fat, and 22% protein) after a 10-h overnight fasting. Blood samples were drawn at 0, 10, 20, 30, 60, 90, 120, and 180 minute relative to the meal ingestion for the measurements of glucose and insulin.
Time frame: before randomisation and end of study
Fasting lipids
after an overnight fasting
Time frame: before randomisation and end of study
hsCRP
high-sensitivity C-reactive protein
Time frame: before randomisation and end of study
oxLDL
oxidized low-density lipoprotein
Time frame: before randomisation and end of study
Adiponectin
Total and high-molecular weight adiponectin
Time frame: before randomisation and end of study
This study is completed, as verified in May 2010. You cannot join it, but the record below documents what was studied.
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Taichung Veterans General Hospital