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CompletedNCT00541437Updated Oct 10, 2007

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

An observational study in Type 2 Diabetes Mellitus, sponsored by Genovate Biotechnology Co., Ltd.,. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2007-10-10.

Sponsored by Genovate Biotechnology Co., Ltd., · Observational

Study type
Observational
Time perspective
Prospective
Enrollment
12
Ages
20 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Type 2 Diabetes Mellitus

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
03

In context

Diabetes Mellitus, Type 2

9,589 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.

This study's enrollment of 12 is below the median of 300 across 1,622 observational studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Genovate Biotechnology Co., Ltd., is the lead sponsor of 13 studies on the registry; none are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Time perspective
Prospective
Enrollment
12 participants (actual)
06

Study locations

1 site
  • National Taiwan university hospital
    Taipei, Taiwan
07

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2006 and a completion of Feb 2007. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 8, 2007
First posted
Oct 10, 2007
Start
May 2006
CompletionActual
Feb 2007
Last update
Oct 10, 2007
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 10, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00541437
Lead sponsor
Genovate Biotechnology Co., Ltd.,
First posted
Oct 10, 2007
Start date
May 2006
Completion
Feb 2007
Last update
Oct 10, 2007

Study contacts

Tien-Shang Huang, M.D
principal investigator · National Taiwan University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2007. You cannot join it, but the record below documents what was studied.

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