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Type 2 Diabetes Patients Switched From Sulfonylurea With Metformin to Glyburide/Metformin Combination Tablet

This study has been completed.
Information provided by:
Genovate Biotechnology Co., Ltd., Identifier:
First received: October 8, 2007
Last updated: October 9, 2007
Last verified: October 2007
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.

Type 2 Diabetes Mellitus

Study Type: Observational
Study Design: Time Perspective: Prospective
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

Resource links provided by NLM:

Further study details as provided by Genovate Biotechnology Co., Ltd.,:

Enrollment: 12
Study Start Date: May 2006
Study Completion Date: February 2007

Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00541437

National Taiwan university hospital
Taipei, Taiwan
Sponsors and Collaborators
Genovate Biotechnology Co., Ltd.,
Principal Investigator: Tien-Shang Huang, M.D National Taiwan University Hospital
  More Information Identifier: NCT00541437     History of Changes
Other Study ID Numbers: GBL L-13
Study First Received: October 8, 2007
Last Updated: October 9, 2007

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
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on June 23, 2017