Type 2 Diabetes MellitusPhase 4NCT01444248
Compare the Compliance of Patients Treated With Once-daily (od) or Twice-daily (Bid) Glimepiride and Metformin Fixed Combination Therapy
A Phase 4 study testing Glimepiride/ Metformin in people with Type 2 Diabetes Mellitus, run by Handok Inc. at 1 site in South Korea.
Trial summary
The study design of this trial is open-label, randomized, multi-center, parallel-group study. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Glimepiride/ Metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2010to May 2012
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged between 18 ~ 75 years at screening
- Patients who have been diagnosed with type 2 DM for at least 3 months
- Patients who were treated with a stable dose with combination therapy of glimepiride 4mg or more and metformin 1000mg or more which can switch to Amaryl M 2/500mg bid or Amaryl Mex 2/500mg 2T od regimen.
- HbA1c ≤ 9 % at randomization
- BMI ≤ 40 kg/m2 at randomization
- Patients who would give the informed consent
- Patients who can perform SMBG and record the data on the patient's diary
- Patients who can understand and use MEMS properly
Who cannot join
- Patients with the medical history of acute metabolic complications such as diabetic ketoacidosis, hyperosmolar nonketotic coma within 3 months prior to the study participation
- Patients who are under insulin therapy at randomization
- Patients who received systemic corticosteroid agent within 4 weeks prior to the study participation
- Patients with acute, severe cardiovascular disease (e.g., heart failure, myocardial infarction, stroke, etc).
- Pregnant or lactating females
- history of drug or alcohol abuse
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- Patients with known hypersensitivity to the ingredient of the study drug or drugs in sulfonylurea, sulfonamide, biguanide class
- Night-shift workers
- Patients with an experience of participating in other clinical trial within 3 months prior to the study participation
- Clinically significant laboratory abnormality on screening labs or any medical condition that would affect the completion or outcome of the study based on investigator's decision
- Patients with serum creatinine level > 1.5 mg/dl in male and > 1.4 mg/dl in female
- Patients with ALT or AST > 3x ULN
- Any conditions requiring help of others with drug administration (e.g. manual disability, serious visual defect, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-center, Open, Randomized, Parallel-group Study to Compare the Compliance of Patients Treated With Once-daily (od) or Twice-daily (Bid) Glimepiride and Metformin Fixed Combination Therapy
The study design of this trial is open-label, randomized, multi-center, parallel-group study.
Read the detailed description
The effectiveness of treatment of a disease depends mainly on two factors: the efficacy of the treatment and the compliance of the patient with this treatment. Polymedication is one of the predisposing factors to low compliance in type 2 DM. It can be expected that a simple regimen may improve compliance. Amaryl Mex phase III trial was not designed to compare the compliance of patients with different dosing regimens of oral antidiabetic drugs. However, it was found that patients' compliance in the morning was better than in the evening, suggesting that Amaryl Mex once daily regimen may improve compliance. Pill count is the gold standard for measuring compliance, but this method provides incomplete and unreliable results. Advanced electronic monitoring device obtains details of patients' behavior during the day and over long periods.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Glimepiride/ Metformin
- Keywords
- Amaryl MEX
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glimepiride/ MetforminDrug
4/1000mg once daily
Glimepiride/ MetforminDrug
4/1000mg bid
| Study group | Role | What they receive |
|---|---|---|
| Amaryl MEX | Experimental | Not described Receives: Drug: Glimepiride/ Metformin |
| Amaryl M | Active comparator | Not described Receives: Drug: Glimepiride/ Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
compliance of patients treated with once-daily or twice-daily
Measured: 24 weeks
Secondary outcomes (3)
Blood glucose lowering effect
Measured: 24 weeks
Episodes of hypoglycaemia
Measured: 24 weeks
other adverse events
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2011 (estimated)
- Study startAug 2010
- Primary completionDec 2011
- Study completionMay 2012
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Handok Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sungwoo Park, professor, Principal investigator, Kangbuk Samsung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01444248
- Sponsor's protocol ID
- HANDOK2009.02
- Status last verified
- Aug 2012
- First submitted
- 21 Sep 2011
- Last updated
- 23 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Open, Randomized, Parallel-group Study to Compare the Compliance of Patients Treated With Once-daily (od) or Twice-daily (Bid) Glimepiride and Metformin Fixed Combination Therapy
- ClinicalTrials.gov ID
- NCT01444248
- Acronym / sponsor ID
- HANDOK2009.02
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Amaryl MEX
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Handok Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 30 Sep 2011 (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 study design of this trial is open-label, randomized, multi-center, parallel-group study.
Detailed description
The effectiveness of treatment of a disease depends mainly on two factors: the efficacy of the treatment and the compliance of the patient with this treatment. Polymedication is one of the predisposing factors to low compliance in type 2 DM. It can be expected that a simple regimen may improve compliance. Amaryl Mex phase III trial was not designed to compare the compliance of patients with different dosing regimens of oral antidiabetic drugs. However, it was found that patients' compliance in the morning was better than in the evening, suggesting that Amaryl Mex once daily regimen may improve compliance. Pill count is the gold standard for measuring compliance, but this method provides incomplete and unreliable results. Advanced electronic monitoring device obtains details of patients' behavior during the day and over long periods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amaryl MEX | Experimental | Drug: Glimepiride/ Metformin |
| Amaryl M | Active comparator | Drug: Glimepiride/ Metformin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients aged between 18 ~ 75 years at screening
- Patients who have been diagnosed with type 2 DM for at least 3 months
- Patients who were treated with a stable dose with combination therapy of glimepiride 4mg or more and metformin 1000mg or more which can switch to Amaryl M 2/500mg bid or Amaryl Mex 2/500mg 2T od regimen.
- HbA1c ≤ 9 % at randomization
- BMI ≤ 40 kg/m2 at randomization
Key exclusion criteria (13 listed)
- Patients with the medical history of acute metabolic complications such as diabetic ketoacidosis, hyperosmolar nonketotic coma within 3 months prior to the study participation
- Patients who are under insulin therapy at randomization
- Patients who received systemic corticosteroid agent within 4 weeks prior to the study participation
- Patients with acute, severe cardiovascular disease (e.g., heart failure, myocardial infarction, stroke, etc).
- Pregnant or lactating females
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 |
|---|---|---|
| Glimepiride/ Metformin4/1000mg once daily | Drug | Amaryl MEX |
| Glimepiride/ Metformin4/1000mg bid | Drug | Amaryl M |
Primary outcome
compliance of patients treated with once-daily or twice-daily
Time frame: 24 weeks
3 secondary outcomes
Blood glucose lowering effect
Time frame: 24 weeks
Episodes of hypoglycaemia
Time frame: 24 weeks
other adverse events
Time frame: 24 weeks
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 23 Aug 2012.
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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.
Sungwoo Park, professor principal investigator
Kangbuk Samsung Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Glimepiride/ Metformin in people with Type 2 Diabetes Mellitus, run by Handok Inc. at 1 site in South Korea.
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 8 inclusion and 13 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 23 Aug 2012. 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 South Korea. 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?
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.
What does the primary outcome measure?
compliance of patients treated with once-daily or twice-daily (time frame: 24 weeks). 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 23 Aug 2012.