Type 2 Diabetes Patients Switched From Sulfonylurea With Metformin to Glyburide/Metformin Combination Tablet
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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.
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Ages Eligible for Study:
20 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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.
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.
Keywords provided by Genovate Biotechnology Co., Ltd.,:
Change from baseline of HbA1c after 16 weeks of treatment
Change from baseline of FPG after 16 weeks of treatment
Change from baseline of diabetes self-care scale by patient on drug administration after 16 weeks of treatment
Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Endocrine System Diseases
Physiological Effects of Drugs