Effects of Acarbose Versus Glibenclamide on MAGE and Oxidative Stress in Patients With Type 2 DM
Information source: Taichung Veterans General Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes Mellitus
Intervention: Acarbose (Drug)
Phase: Phase 4
Status: Completed
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
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
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Mean Amplitude Glycemic ExcursionOxidative stress
Secondary outcome: HbA1cfasting glucose Insulin response Fasting lipids hsCRP oxLDL Adiponectin
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 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.
Eligibility
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.
Locations and Contacts
Taichung Veterans General Hospital, Taichung, Taiwan
Additional Information
Starting date: January 2007
Last updated: May 11, 2010
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