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

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Acarbose, Glibenclamide, Metformin

Primary Measures

• Mean Amplitude Glycemic Excursion
• Oxidative stress

Secondary Measures

• HbA1c
• fasting glucose,
• Insulin response,
• Fasting lipids,
• Inflammatory molecules (ICAM, V-CAM, hsCRP),
• oxLDL,
• adiponectin,
• urinary albumin excretion rate,
• urinary 8-iso PGF2 alpha

Inclusion Criteria:

• Patients may be included in the clinical trial only if they meet all of the following criteria:
• 1. Male or female outpatients;
• 2. Age 30 - 70 years;
• 3. Patients have failed to achieve glycemic control with diet, exercise and max. 2
• OHA; Hemoglobin A1c level between 7.0 to 11.0 % at V1 and 7-11.5 % at V4.
• 4. Diagnosis of diabetes mellitus is over a minimum 3-month period;
• 5. All patients give written informed consent;
• 6. For female patients of childbearing potential, the following criteria will be applied:
• Using adequate contraception since last menses and will continue to use adequate contraception during the clinical trial.
• Not lactating.
• Negative pregnancy test (urine) within 7 days prior to the first dose of study medication. (Note: the inclusion criterion 6 does not apply to menopausal female).

Exclusion Criteria:

• Patients will be excluded from the clinical trial for any of the following reasons:
• 1. Patients with a serum creatinine concentration greater than 132.6 mmol/L (1.5 mg/dL) or liver function impairment (AST and ALT 2.5 times upper limit of normal range);
• 2. Patients have laboratory test abnormality (biochemistry, hematology, or urinalysis), which in the investigator’s opinion might confound the clinical trial. However, patients with hyperlipemia, elevated cholesterol or triglyceride levels, or lipid metabolism disorders are eligible;
• 3. Use of chronic insulin therapy;
• 4. Patients with medical conditions that could promote lactic acidosis, such as renal or hepatic disease, unstable angina, congestive heart failure (New York
• Heart Association Functional Classification III and IV), or chronic obstructive pulmonary disease, e.g. respiratory insufficiency, hypoxemic condition;
• 5. Patients with a history of hypersensitivity to metformin hydrochloride, glibenclamide or acarbose;
• 6. Patients receive an investigational drug within 30 days prior to admission to the clinical trial;
• 7. Patients with significant alcohol, drug or medication abuse as judged by the investigator.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 30 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Taichung Veterans General Hospital

Overall Clinical Trial Officials and Contacts

Wayne H Sheu, MD, PhD Principal Investigator Taichung Veterans General Hospital  

Overall Contact: Wayne H Sheu, MD, PhD 886-4-23592525 whhsheu@vghtc.gov.tw

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00417729

Study ID Number: IRB951004/C06211

ClinicalTrials.gov Identifier: NCT00417729

Health Authority: Taiwan: Department of Health