Diabetes Mellitus, Type 2Phase 4NCT00336310
A Double-Blind, Randomized, Parallel, Comparative Study to Evaluate the Efficacy and Safety of an Antidiabetic Agent Repaglinide for the Treatment of Type 2 Diabetes Mellitus Patients
A Phase 4 study testing Repaglinide in people with Diabetes Mellitus, Type 2, run by National Cheng-Kung University Hospital at 2 sites in Taiwan.
Trial summary
The purpose of this study is to determine whether a new-brand of repaglinide is effective in the treatment of type 2 diabetes patients. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Repaglinide
- How many people
- 50 participants
- Where
- 2 sitesTaiwan
- Study dates
- Jul 2006to not given
- Phase
- Phase 4
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mentally competent adults of either sex with age 30-75 years old
- Patients have type 2 diabetes mellitus diagnosed after 25 years of age
- Patients have been in poor glycemic control by diet or exercise for at least 1 month or by a stable dose of metformin for at least 3 months before study; poor glycemic control is defined as: Glycosylated hemoglobin A1c (HbA1c) 7.1-11.0%
- Patients have signed the written informed consent form
Who cannot join
- Patients with type 1 diabetes mellitus (insulin¬dependent)
- Patients taking medications possibly to affect significantly the intestinal motility or the absorption of nutrients.
- Female patients who are pregnant or trying to become pregnant or lactating during the study
- Patients with alcohol, drugs or medications abuse considered by the investigator
- Patients with impaired liver function (AST, ALT>2.5× upper limit of normal)
- Patients with impaired kidney function (serum creatinine>3.0 mg/dl)
Show all 19Show fewer
- Patients with unstable cardiovascular conditions (e.g., New York Heart Association functional class III or IV congestive heart failure or a history of myocardial infarction or stroke)
- Patients with emphysema or chronic bronchitis
- Patients with diabetic ketoacidosis
- Patients with hepatic cirrhosis
- Patients with on-going inflammatory bowel disease, colonic ulceration, partial intestinal obstruction
- Patients are predisposed to intestinal obstruction
- Patients with chronic intestinal diseases related to marked disorders of digestion or absorption
- Patients with clinically significant medical conditions that may deteriorate clinically due to gastrointestinal gas increase
- Patients with a history of lactic acidosis
- Patients with a history of allergic to repaglinide
- Patients took any hypoglycemic agent except for metformin within 3 months before study
- Patients participated investigational drug trial within 1 month before entering this study
- Patients with any other serious diseases considered by the investigator not in the condition to enter the trial
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
National Cheng-Kung University Hospital
Tainan, 704
H-Y Ou, MD
National Cheng-Kung University Hospital
Tainan, 704
About this study
The purpose of this study is to determine whether a new-brand of repaglinide is effective in the treatment of type 2 diabetes patients.
Read the detailed description
This study is designed to evaluate the efficacy and safety of a new-brand of repaglinide X® in comparison to Novonorm® for the treatment of type 2 diabetes mellitus patients. Mentally competent patients with age of 30 to 75 years old in Taiwan of either sex with type 2 diabetes mellitus will be included. All eligible subjects will be randomized into treatment groups in 1:1 ratio. The treatment will consist of either X® or Novonorm® tid before meal for 12 weeks of treatment. The primary endpoints include the net change of HbA!c, fasting plasma glucose(FPG)and postprandial plasma glucose(PPG)at the end of 12th week evaluation compared to the baseline visit. Also, safety profiles including adverse event (such as hypoglycemia) incidences, blood pressure, liver, kidney function test will be monitored.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Repaglinide
- Keywords
- Diabetes Mellitus, Treatment, Repaglinide
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RepaglinideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
change of HbA1c at 12 weeks
Change of fasting plasma glucose (FPG) at 12 weeks
Change of postprandial plasma glucose (PPG) at 12 weeks
Secondary outcomes (2)
Safety parameters including adverse events such as hypoglycemia
change of liver and renal function test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2006 (estimated)
- Study startJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- T-J Wu, MD, Principal investigator, National Cheng-Kung University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00336310
- Sponsor's protocol ID
- YSRE0001
- Status last verified
- Jun 2006
- First submitted
- 12 Jun 2006
- Last updated
- 13 Jun 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Parallel, Comparative Study to Evaluate the Efficacy and Safety of an Antidiabetic Agent Repaglinide for the Treatment of Type 2 Diabetes Mellitus Patients
- ClinicalTrials.gov ID
- NCT00336310
- Acronym / sponsor ID
- YSRE0001
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes Mellitus, Treatment, Repaglinide
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- Jul 2006
- First posted
- 13 Jun 2006 (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.
The purpose of this study is to determine whether a new-brand of repaglinide is effective in the treatment of type 2 diabetes patients.
Detailed description
This study is designed to evaluate the efficacy and safety of a new-brand of repaglinide X® in comparison to Novonorm® for the treatment of type 2 diabetes mellitus patients. Mentally competent patients with age of 30 to 75 years old in Taiwan of either sex with type 2 diabetes mellitus will be included. All eligible subjects will be randomized into treatment groups in 1:1 ratio. The treatment will consist of either X® or Novonorm® tid before meal for 12 weeks of treatment. The primary endpoints include the net change of HbA!c, fasting plasma glucose(FPG)and postprandial plasma glucose(PPG)at the end of 12th week evaluation compared to the baseline visit. Also, safety profiles including adverse event (such as hypoglycemia) incidences, blood pressure, liver, kidney function test will be monitored.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Mentally competent adults of either sex with age 30-75 years old
- Patients have type 2 diabetes mellitus diagnosed after 25 years of age
- Patients have been in poor glycemic control by diet or exercise for at least 1 month or by a stable dose of metformin for at least 3 months before study; poor glycemic control is defined as: Glycosylated hemoglobin A1c (HbA1c) 7.1-11.0%
- Patients have signed the written informed consent form
Key exclusion criteria (19 listed)
- Patients with type 1 diabetes mellitus (insulin¬dependent)
- Patients taking medications possibly to affect significantly the intestinal motility or the absorption of nutrients.
- Female patients who are pregnant or trying to become pregnant or lactating during the study
- Patients with alcohol, drugs or medications abuse considered by the investigator
- Patients with impaired liver function (AST, ALT>2.5× upper limit of normal)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repaglinide | Drug | – |
Primary outcome
change of HbA1c at 12 weeks
Change of fasting plasma glucose (FPG) at 12 weeks
Change of postprandial plasma glucose (PPG) at 12 weeks
2 secondary outcomes
Safety parameters including adverse events such as hypoglycemia
change of liver and renal function test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2006.
Related trials for Diabetes Mellitus, Type 2
RecruitingObservational study
Phenotyping Patients With Type 2 Diabetes Mellitus and Cancer
Diabetes Mellitus, Type 2, Cancer
Recruiting
Starting Technology in At Risk Type 1 Diabetes Study
Diabetes Mellitus, Type 1
Active, not recruiting
Helping Adults With Type 2 Diabetes Use Their Health Data for Healthy Diabetes Self-Management
Type 2 Diabetes Mellitus (T2DM)
Active, not recruiting
Community-Empowerment and Environmental Enrichment-based Co-management (CEEEC) Model and Mechanisms for Improving Health of Older Stroke Patients With Multimorbidity
Hypertension, Type 2 Diabetes Mellitus (T2DM)
Enrolling by invitationObservational study
Personalizing A1c Using Hematologic Indices and CGM for Accurate Diabetes Diagnosis
Type 2 Diabetes
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.
T-J Wu, MD principal investigator
National Cheng-Kung University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Repaglinide in people with Diabetes Mellitus, Type 2, run by National Cheng-Kung University Hospital at 2 sites 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 4 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 13 Jun 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact H.Y. Ou, MD (886-6-2353535 ext. 2177, wahoryi@mail.ncku.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of HbA1c at 12 weeks. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 13 Jun 2006; AzTrials last refreshed its copy on 30 Oct 2026.