Type 2 Diabetes MellitusPhase 4NCT00612144
Study Comparing Efficacy and Safety of Amaryl M and Metformin Uptitraion to Type 2 DM
A Phase 4 study testing Glimepiride/metformin fixed combination and Metformin HCl in people with Type 2 Diabetes Mellitus, run by Handok Inc. at 1 site in South Korea.
Trial summary
The aim of this study is to compare the efficacy and safety of early combination therapy with Amaryl M with that of uptitration of metformin monotherapy in patients with type 2 DM inadequately controlled by prior monotherapy with metformin. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Glimepiride/metformin fixed combination and Metformin HCl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2007to May 2009
- 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
- Ages 30 to 75 at the time of screening visit
- Subjects with type 2 DM diagnosed for at least 3 months before screening
- Subjects with type 2 DM treated with monotherapy of 500mg ≤ metformin ≤ 1000mg for at lest 4 weeks prior to screening
- HbA1c ≥ 7.0% but ≤ 10.0% at the time of screening visit
- 21 kg/m2 ≤ BMI ≤ 40 kg/m2
- A negative pregnancy test for all females of childbearing potential
- Provision of signed and dated informed consent prior to any study procedures
- Ability and willingness to perform SMBG and record the data on the subject's diary
Who cannot join
- A history of acute metabolic complications such as diabetic ketoacidosis or hyperosmolar nonketotic coma within 3 months before screening
- Current therapy with anti-hyperglycemic agents (except metformin) use in the 4 weeks (8 weeks in case of thiazolidinedione) before screening
- Concomitant treatment prohibited during the study period
- Any oral hypoglycemic agent other than glimepiride, metformin HCl, and fixed-dose combination of glimepiride and metformin HCl
- Any insulin therapy over 7 days consecutively or intermittently in order to treat acute metabolic decompensation or systemic infection during the study
- Intermittent use of systemic corticosteroids or large dose of inhaled steroids
Show all 15Show fewer
- Subjects with clinically significant renal (serum creatinine level > 1.5 mg/dL in male and > 1.4 mg/dL in female) or hepatic disease (ALT and AST > 2x ULN)
- Clinically significant laboratory abnormality on screening labs or any medical condition that would affect the completion or outcome of the study in the opinion of the investigator and/or sponsor;
- Pregnant or lactating females
- History of drug or alcohol abuse
- Subjects who have a history of noncompliance with regards to follow-up medical care
- Subjects with known hypersensitivity to glimepiride, metformin HCL
- Night-shift workers
- Treatment with any investigational product in the last 3 months before study entry
- Others; subjects who have participated in this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Parallel-group, Open Study to Compare the Efficacy and Safety of Early Combination Therapy With Amaryl M to Metformin Uptitration in Type 2 DM Patients Inadequately Controlled on Metformin HCL
The aim of this study is to compare the efficacy and safety of early combination therapy with Amaryl M with that of uptitration of metformin monotherapy in patients with type 2 DM inadequately controlled by prior monotherapy with metformin.
Read the detailed description
Treatment algorithms for type 2 DM generally employ monotherapy as a first-line pharmacologic treatment option. Disease progression renders monotherapy less effective in controlling blood glucose over time, with approximately half of the patients requiring additional therapy by 3 years after diagnosis. As a result, the use of multiple pharmacologic agents to control blood glucose is well accepted.
In combination therapy, selection of suitable drug may be individualized depending on their health conditions. However, it is advisable to select drugs having different mechanism considering their complimentary action with each other. Therefore, sulfonylureas and metformin HCL is the best combination in which "insulin deficiency" and "insulin resistance", the basic two pathophysiologies in type 2 diabetes could be targeted. The efficacy and safety of the combination with sulfonylureas and metformin HCL have been proven in numerous clinical studies as combination is more effective than monotherapy using each drug in blood glucose control.
Also, new approaches are required in order to attain and maintain good glycaemic control over time and aggressive earlier introduction of combination therapy is being increasingly recommended over conventional stepwise strategies.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Glimepiride/metformin fixed combination, Metformin HCl
- Keywords
- Type 2 DM
- 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/metformin fixed combinationDrug
Also called Amaryl M
Amaryl M 1/250mg~4/1000mg bid for 12~26 weeks
- Maintenance dose for 10 weeks after 2~14 weeks of dose titration
- Dose titration according to titration algorithm based on daily mean SMBG
Metformin HClDrug
Also called Diabex
Metformin HCl 500mg~1250mg bid for 12~26 weeks
- Maintenance dose for 10 weeks after 2~14 weeks of dose titration
- Dose titration according to titration algorithm based on daily mean SMBG
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Amaryl M group Receives: Drug: Glimepiride/metformin fixed combination |
| 2 | Active comparator | Metformin group Receives: Drug: Metformin HCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adjusted mean changes in HbA1c from baseline to the last visit
Measured: 12~24 weeks
Secondary outcomes (5)
Adjusted mean changes in FPG from baseline to the last visit
Measured: 12~24 weeks
Response rate based on HbA1c and FPG levels measured at the last visit
Measured: 12~24 weeks
Frequency with hypoglycemic episode
Measured: 12~24 weeks
Adverse event
Measured: 12~24 weeks
Abnormal change from baseline in clinical laboratory
Measured: 12~24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2008 (estimated)
- Study startDec 2007
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Handok Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Dong Seob CHOI, Principal investigator, Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00612144
- Sponsor's protocol ID
- GLIME_L_02861
- Status last verified
- Mar 2013
- First submitted
- 7 Jan 2008
- Last updated
- 28 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Kim HS, Kim DM, Cha BS, Park TS, Kim KA, Kim DL, Chung CH, Park JH, Jang HC, Choi DS. Efficacy of glimepiride/metformin fixed-dose combination vs metformin uptitration in type 2 diabetic patients inadequately controlled on low-dose metformin monotherapy: A randomized, open label, parallel group, multicenter study in Korea. J Diabetes Investig. 2014 Nov;5(6):701-8. doi: 10.1111/jdi.12201. Epub 2014 Mar 16.
PubMed 25422771
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Parallel-group, Open Study to Compare the Efficacy and Safety of Early Combination Therapy With Amaryl M to Metformin Uptitration in Type 2 DM Patients Inadequately Controlled on Metformin HCL
- ClinicalTrials.gov ID
- NCT00612144
- Acronym / sponsor ID
- GLIME_L_02861
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Type 2 DM
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- Handok Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 11 Feb 2008 (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 aim of this study is to compare the efficacy and safety of early combination therapy with Amaryl M with that of uptitration of metformin monotherapy in patients with type 2 DM inadequately controlled by prior monotherapy with metformin.
Detailed description
Treatment algorithms for type 2 DM generally employ monotherapy as a first-line pharmacologic treatment option. Disease progression renders monotherapy less effective in controlling blood glucose over time, with approximately half of the patients requiring additional therapy by 3 years after diagnosis. As a result, the use of multiple pharmacologic agents to control blood glucose is well accepted.
In combination therapy, selection of suitable drug may be individualized depending on their health conditions. However, it is advisable to select drugs having different mechanism considering their complimentary action with each other. Therefore, sulfonylureas and metformin HCL is the best combination in which "insulin deficiency" and "insulin resistance", the basic two pathophysiologies in type 2 diabetes could be targeted. The efficacy and safety of the combination with sulfonylureas and metformin HCL have been proven in numerous clinical studies as combination is more effective than monotherapy using each drug in blood glucose control.
Also, new approaches are required in order to attain and maintain good glycaemic control over time and aggressive earlier introduction of combination therapy is being increasingly recommended over conventional stepwise strategies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Glimepiride/metformin fixed combinationAmaryl M group |
| 2 | Active comparator | Drug: Metformin HClMetformin group |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Ages 30 to 75 at the time of screening visit
- Subjects with type 2 DM diagnosed for at least 3 months before screening
- Subjects with type 2 DM treated with monotherapy of 500mg ≤ metformin ≤ 1000mg for at lest 4 weeks prior to screening
- HbA1c ≥ 7.0% but ≤ 10.0% at the time of screening visit
- 21 kg/m2 ≤ BMI ≤ 40 kg/m2
Key exclusion criteria (15 listed)
- A history of acute metabolic complications such as diabetic ketoacidosis or hyperosmolar nonketotic coma within 3 months before screening
- Current therapy with anti-hyperglycemic agents (except metformin) use in the 4 weeks (8 weeks in case of thiazolidinedione) before screening
- Concomitant treatment prohibited during the study period
- Subjects with clinically significant renal (serum creatinine level > 1.5 mg/dL in male and > 1.4 mg/dL in female) or hepatic disease (ALT and AST > 2x ULN)
- Clinically significant laboratory abnormality on screening labs or any medical condition that would affect the completion or outcome of the study in the opinion of the investigator and/or sponsor;
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/metformin fixed combinationAlso: Amaryl MAmaryl M 1/250mg~4/1000mg bid for 12~26 weeks * Maintenance dose for 10 weeks after 2~14 weeks of dose titration * Dose titration according to titration algorithm based on daily mean SMBG | Drug | 1 |
| Metformin HClAlso: DiabexMetformin HCl 500mg~1250mg bid for 12~26 weeks * Maintenance dose for 10 weeks after 2~14 weeks of dose titration * Dose titration according to titration algorithm based on daily mean SMBG | Drug | 2 |
Primary outcome
Adjusted mean changes in HbA1c from baseline to the last visit
Time frame: 12~24 weeks
5 secondary outcomes
Adjusted mean changes in FPG from baseline to the last visit
Time frame: 12~24 weeks
Response rate based on HbA1c and FPG levels measured at the last visit
Time frame: 12~24 weeks
Frequency with hypoglycemic episode
Time frame: 12~24 weeks
Adverse event
Time frame: 12~24 weeks
Abnormal change from baseline in clinical laboratory
Time frame: 12~24 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 28 Mar 2013.
- Derived from this study: PubMed 25422771Kim HS, Kim DM, Cha BS, Park TS, Kim KA, Kim DL, Chung CH, Park JH, Jang HC, Choi DS. Efficacy of glimepiride/metformin fixed-dose combination vs metformin uptitration in type 2 diabetic patients inadequately controlled on low-dose metformin monotherapy: A randomized, open label, parallel group, multicenter study in Korea. J Diabetes Investig. 2014 Nov;5(6):701-8. doi: 10.1111/jdi.12201. Epub 2014 Mar 16.
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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.
Dong Seob CHOI principal investigator
Korea University Anam 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 fixed combination and Metformin HCl 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 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 28 Mar 2013. 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?
Adjusted mean changes in HbA1c from baseline to the last visit (time frame: 12~24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00612144, which also lists 1 linked publication.
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 28 Mar 2013.