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.,
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.
||Time Perspective: Prospective
||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
| Study Start Date:
| Study Completion Date:
|Ages Eligible for Study:
||20 Years to 75 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00541437
|National Taiwan university hospital
|Taipei, Taiwan |
Genovate Biotechnology Co., Ltd.,
||Tien-Shang Huang, M.D
||National Taiwan University Hospital
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 8, 2007
||October 9, 2007
||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:
ClinicalTrials.gov processed this record on April 17, 2014
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Endocrine System Diseases
Physiological Effects of Drugs