To evaluate the efficacy and safety of type 2 diabetes patients switched from sulfonylurea
co-administered with metformin to glyburide/metformin combination tablet. It is expected that
safety and efficacy of GlucoMet® is not inferior to co-administration of sulfonylurea and
metformin.
Inclusion Criteria:
- Male or female age between 20 to 75 years and were diagnosed with type-2 DM for a
minimum of 4 months before baseline.
- Maintain stable dose of sulfonylurea and metformin co-administered 4 months before
baseline.
- Consider suitable to switch from current therapeutic dose to one of the eight testing
regimens.
- FPG of 80-200mg/dl at screening visit
- 6. 5% ≦ HbA1c ≦ 9% at screening visit, and change of HbA1c ≦ 1% within 12 weeks before
screening visit.
- The body index must be between 18. 5 and 35 Kg/m2 at screening visit.
- Sign and date the Informed Consent Form
Exclusion Criteria:
- Renal disease or renal dysfunction (e. g. serum creatinine > 1. 5mg/dl)
- Currently significant GI disorder (such as peptic ulcer or diarrhea requiring chronic
medical treatment) or which may interfere with absorption of the study drugs.
- History or concurrent liver disease or hepatic impairment (total bilirubin above upper
normal limit, ALT or AST above 2. 5 times of upper normal limit at screening visit.)
- Acute or chronic metabolic acidosis, including lactic acidosis, diabetic ketoacidosis,
with or without coma.
- History of cardiovascular collapse (shock) or congestive heart failure (function class
III to IV).
- History of stroke, myocardial infarction, coronary revascularization, or arrhythmia
that requires medical treatment, within past 6 months.
- Having proliferative retinopathy.
- Current acute infection, including systemic infection with fever and/or sepsis, or
pulmonary infection, cellulitis, etc.
- Having been treated with insulin during past 6 months, or treated with acarbose or
glitazones with change of daily dose past 4 months.
- Seriously dehydrated.
- History of alcoholism (all the time or short-term heavy drinking) or drug abuse, or
taking other investigational drug.
- Pregnant or breast feeding women or planning a pregnancy.
- Having a surgery within 4 weeks prior to entering the study or a history of cancer
within five years.
- Known hypersensitive to glyburide or metformin hydrochloride.
- Any clinical condition or significant concurrent disease judged by the investigator to
complicate the evaluation of the study treatment.
