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

This study has been completed.
Sponsor:
Information provided by:
Genovate Biotechnology Co., Ltd.,
ClinicalTrials.gov Identifier:
NCT00541437
First received: October 8, 2007
Last updated: October 9, 2007
Last verified: October 2007
  Purpose

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
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
  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00541437

Locations
Taiwan
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00541437     History of Changes
Other Study ID Numbers: GBL L-13
Study First Received: October 8, 2007
Last Updated: October 9, 2007
Health Authority: Taiwan: Institutional Review Board

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
Glyburide
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 19, 2014