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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

This study is currently recruiting participants.
Verified by Taichung Veterans General Hospital, January 2007

Sponsors and Collaborators: Taichung Veterans General Hospital
Taipei Veterans General Hospital,Taiwan
Changhua Christian Hospital
Information provided by: Taichung Veterans General Hospital
ClinicalTrials.gov Identifier: NCT00417729
  Purpose

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


Condition Intervention Phase
Diabetes Mellitus
Drug: Acarbose, Glibenclamide, Metformin
Phase IV

MedlinePlus related topics:   Diabetes    Stress   

Drug Information available for:   Glyburide    Metformin    Metformin hydrochloride    Acarbose   

U.S. FDA Resources

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

Further study details as provided by Taichung Veterans General Hospital:

Primary Outcome Measures:
  • Mean Amplitude Glycemic Excursion
  • Oxidative stress

Secondary Outcome 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

Estimated Enrollment:   120
Study Start Date:   January 2007

  Eligibility
Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00417729

Contacts
Contact: Wayne H Sheu, MD, PhD     886-4-23592525 ext 3068     whhsheu@vghtc.gov.tw    

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

Sponsors and Collaborators
Taichung Veterans General Hospital
Taipei Veterans General Hospital,Taiwan
Changhua Christian Hospital

Investigators
Principal Investigator:     Wayne H Sheu, MD, PhD     Taichung Veterans General Hospital    
  More Information


Study ID Numbers:   IRB951004/C06211
First Received:   January 1, 2007
Last Updated:   January 1, 2007
ClinicalTrials.gov Identifier:   NCT00417729
Health Authority:   Taiwan: Department of Health

Keywords provided by Taichung Veterans General Hospital:
Diabetes  
Acarobse  
Metformin  
oxidative stress
Mean amplitude Glycemic Excursion
Meal test

Study placed in the following topic categories:
Glyburide
Acarbose
Metabolic Diseases
Metformin
Diabetes Mellitus
Endocrine System Diseases
Stress
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

Additional relevant MeSH terms:
Hypoglycemic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 22, 2008




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