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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00541437
• Other study ID #: GBL L-13
• Status: Completed
• Phase: N/A
• First received: October 8, 2007
• Last updated: October 9, 2007
• Start date: May 2006
• Est. completion date: February 2007

Study information

• Verified date: October 2007
• Source: Genovate Biotechnology Co., Ltd.,
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Locations

Country	Name	City	State
Taiwan	National Taiwan university hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Genovate Biotechnology Co., Ltd.,

Country where clinical trial is conducted

Taiwan,