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

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 Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus

• Study Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Genovate Biotechnology Co., Ltd.,
• Investigators: Principal Investigator: Tien-Shang Huang, M.D, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2006
• Study Completion (Actual): February 1, 2007

Study Registration Dates

• First Submitted: October 8, 2007
• First Submitted That Met QC Criteria: October 9, 2007
• First Posted (Estimate): October 10, 2007

Study Record Updates

• Last Update Posted (Estimate): October 10, 2007
• Last Update Submitted That Met QC Criteria: October 9, 2007
• Last Verified: October 1, 2007

More Information

Terms related to this study

• Keywords: 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: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: GBL L-13