Type 2 Diabetes Patients Switched From Sulfonylurea With Metformin to Glyburide/Metformin Combination Tablet
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female age between 20 to 75 years and were diagnosed with type-2 DM for a minimum of 4 months before baseline.
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Maintain stable dose of sulfonylurea and metformin co-administered 4 months before baseline.
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Consider suitable to switch from current therapeutic dose to one of the eight testing regimens.
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FPG of 80-200mg/dl at screening visit
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6.5% ≦ HbA1c ≦ 9% at screening visit, and change of HbA1c ≦ 1% within 12 weeks before screening visit.
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The body index must be between 18.5 and 35 Kg/m2 at screening visit.
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Sign and date the Informed Consent Form
Exclusion Criteria:
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Renal disease or renal dysfunction (e.g. serum creatinine > 1.5mg/dl)
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Currently significant GI disorder (such as peptic ulcer or diarrhea requiring chronic medical treatment) or which may interfere with absorption of the study drugs.
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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.)
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Acute or chronic metabolic acidosis, including lactic acidosis, diabetic ketoacidosis, with or without coma.
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History of cardiovascular collapse (shock) or congestive heart failure (function class III to IV).
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History of stroke, myocardial infarction, coronary revascularization, or arrhythmia that requires medical treatment, within past 6 months.
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Having proliferative retinopathy.
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Current acute infection, including systemic infection with fever and/or sepsis, or pulmonary infection, cellulitis, etc.
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Having been treated with insulin during past 6 months, or treated with acarbose or glitazones with change of daily dose past 4 months.
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Seriously dehydrated.
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History of alcoholism (all the time or short-term heavy drinking) or drug abuse, or taking other investigational drug.
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Pregnant or breast feeding women or planning a pregnancy.
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Having a surgery within 4 weeks prior to entering the study or a history of cancer within five years.
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Known hypersensitive to glyburide or metformin hydrochloride.
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Any clinical condition or significant concurrent disease judged by the investigator to complicate the evaluation of the study treatment.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | National Taiwan university hospital | Taipei | Taiwan |
Sponsors and Collaborators
- Genovate Biotechnology Co., Ltd.,
Investigators
- Principal Investigator: Tien-Shang Huang, M.D, National Taiwan University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GBL L-13