Effects of Acarbose Versus Glibenclamide on MAGE and Oxidative Stress in Patients With Type 2 DM
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 4

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
    

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.
    

Intervention name(s): Acarbose
Intervention type(s): Drug
Intervention description(s): 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.
Other intervention name(s): glibenclamide
Intervention MeSH terms: Acarbose; Glyburide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes; Acarobse; Metformin; oxidative stress; Mean amplitude Glycemic Excursion; Meal test