Type 2 Diabetes MellitusNCT00541437
Type 2 Diabetes Patients Switched From Sulfonylurea With Metformin to Glyburide/Metformin Combination Tablet
An observational study of Type 2 Diabetes Mellitus, run by Genovate Biotechnology Co., Ltd., at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- How many people
- 12 participants
- Where
- 1 siteTaiwan
- Study dates
- May 2006to Feb 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- 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
- Medical subject headings
- Diabetes Mellitus, Type 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2007 (estimated)
- Study startMay 2006
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genovate Biotechnology Co., Ltd.,
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Tien-Shang Huang, M.D, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00541437
- Sponsor's protocol ID
- GBL L-13
- Status last verified
- Oct 2007
- First submitted
- 8 Oct 2007
- Last updated
- 10 Oct 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00541437
- Acronym / sponsor ID
- GBL L-13
- Conditions
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Genovate Biotechnology Co., Ltd.,Industry (pharma, biotech, devices)
- Study start
- May 2006
- Study completion
- Feb 2007 (actual)
- First posted
- 10 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (15 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tien-Shang Huang, M.D principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes Mellitus, run by Genovate Biotechnology Co., Ltd., at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2007.