Compare Effect of Acarbose Versus Glibenclamide on Mean Amplitude of Glycemic Excursion and Oxidative Stress in Patients With Type 2 DM Failed to Metformin Monotherapy

Condition(s) targeted: Diabetes Mellitus

Intervention: Acarbose, Glibenclamide, Metformin (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Taichung Veterans General Hospital

Official(s) and/or principal investigator(s):
Wayne H Sheu, MD, PhD, Principal Investigator, Affiliation: Taichung Veterans General Hospital

Overall contact:
Wayne H Sheu, MD, PhD, Phone: 886-4-23592525, Ext: 3068, Email: whhsheu@vghtc.gov.tw

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

Primary outcome:

Mean Amplitude Glycemic Excursion

Oxidative stress

Secondary outcome:

HbA1c

fasting glucose,

Insulin response,

Fasting lipids,

Inflammatory molecules (ICAM, V-CAM, hsCRP),

oxLDL,

adiponectin,

urinary albumin excretion rate,

urinary 8-iso PGF2 alpha

Minimum age: 30 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

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.

Wayne H Sheu, MD, PhD, Phone: 886-4-23592525, Ext: 3068, Email: whhsheu@vghtc.gov.tw

Taichung Veterans General Hospital, Taichung, Taiwan; Recruiting
Wayne H Sheu, MD, PhD, Phone: 886-4-23592525, Ext: 3068, Email: whhsheu@vghtc.gov.tw
I Te Lee, MD, MS, Sub-Investigator

Starting date: January 2007
Last updated: January 1, 2007