Official Title: “An Open-Label Study to Investigate the Efficacy and Safety of Type 2 Diabetes Patients Switched From Sulfonylurea With Metformin to Glyburide/Metformin Combination Tablet”

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.

Study Type: Observational

Study Design: Prospective

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Genovate Biotechnology Co., Ltd.,

Overall Clinical Trial Officials and Contacts

Tien-Shang Huang, M.D Principal Investigator National Taiwan University Hospital  

Information obtained from ClinicalTrials.gov on October 07, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00541437

Study ID Number: GBL L-13

ClinicalTrials.gov Identifier: NCT00541437

Health Authority: Taiwan: Institutional Review Board