Type 2 Diabetes MellitusPhase 4NCT00913367
Efficacy/Safety Study of Amaryl®M 1/500 mg Twice Daily Versus Amaryl® 4 mg Both in Combination With Lantus® in Type 2 Diabetes Mellitus
A Phase 4 study testing glimepiride + insulin glargine (Amaryl + Lantus) and glimepiride/metformin fixed combination+insulin glargine (AmarylM + Lantus) in people with Type 2 Diabetes Mellitus, run by Handok Inc. at 1 site in South Korea.
Trial summary
The purpose of this study is to compare the efficacy of Amaryl®M 1/500 mg twice daily versus Amaryl® 4 mg both in combination with Lantus® once-daily regimen in type 2 Diabetes Mellitus patients with inadequate glycemic control. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- glimepiride + insulin glargine (Amaryl + Lantus) and glimepiride/metformin fixed combination+insulin glargine (AmarylM + Lantus)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2009to Nov 2010
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 20 years old with type 2 DM
- Patients with inadequate glycemic control despite continuous use of tolerable or maximal doses of one or more OADs for 3months or more.
- 7%<HbA1c<11 % at screening
- 21 kg/m2 ≤ BMI ≤ 30 kg/m2
- Patents who need insulin add-on therapy based on investigator's discretion
- Patients who would give the informed consent
- Patients who can perform SMBG and record the data on the patient's diary
Who cannot join
- History of acute metabolic complications such as diabetic ketoacidosis or hyperosmolar nonketotic coma within 3 months before screening
- Pregnant or lactating females
- History of drug or alcohol abuse
- Patients with known hypersensitivity to glimepiride, metformin HCL or insulin
- Night-shift workers
- Patients who are under insulin therapy at screening
Show all 10Show fewer
- Treatment with any investigational products in the last 3 months before screening
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-center, Open, Randomized, Parallel-group, 2 Arm Study to Compare the Efficacy and Safety of Amaryl®M 1/500mg Twice Daily Versus Amaryl® 4mg Both in Combination With Lantus® Once-daily Regimen in Type 2 Diabetes Mellitus Patients With Inadequate Glycemic Control
The purpose of this study is to compare the efficacy of Amaryl®M 1/500 mg twice daily versus Amaryl® 4 mg both in combination with Lantus® once-daily regimen in type 2 Diabetes Mellitus patients with inadequate glycemic control.
Read the detailed description
There are several kinds of oral antidiabetic drugs (OADs) that are used in the treatment of patients with type 2 DM. Among them, sulfonylurea and metformin are well-established first-line OADs. However, as the beta cell dysfunction progresses over time, patients fail to achieve good glycemic control with OADs alone and need further treatment intensification, usually involving the introduction of insulin either alone or in combination with OADs. Now, an OAD combined with bedtime insulin is one of the recommended treatment options for patients with type 2 DM and OAD failure. But, it still remains unclear which OADs are the most effective in combination with insulin for the treatment of type 2 DM.
so, this study we will be able to verify which OADs are the most effective in combination with insulin for the treatment of type 2 DM.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- glimepiride + insulin glargine (Amaryl + Lantus), glimepiride/metformin fixed combination+insulin glargine (AmarylM + Lantus)
- Keywords
- Type 2 Diabetes Mellitus
- 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 + insulin glargine (Amaryl + Lantus)Drug
Also called Amaryl, Lantus injection solostar
- Amaryl® 4 mg at breakfast + Lantus® at dinner
- The initial dose of Lantus® is 0.2IU/kg at baseline. Lantus® titration will be made by patients every 3 days based on the mean value of previous 3 fasting SMBG level before breakfast
glimepiride/metformin fixed combination+insulin glargine (AmarylM + Lantus)Drug
Also called Amaryl M, Lantus injection solostar
- Amaryl® M 1/500 mg at breakfast + Amaryl® M 1/500 mg at dinner + Lantus® at dinner
- The initial dose of Lantus® is 0.2IU/kg at baseline. Lantus® titration will be made by patients every 3 days based on the mean value of previous 3 fasting SMBG level before breakfast
| Study group | Role | What they receive |
|---|---|---|
| Amaryl group | Active comparator | Not described Receives: Drug: glimepiride + insulin glargine (Amaryl + Lantus) |
| Amaryl M group | Experimental | Not described Receives: Drug: glimepiride/metformin fixed combination+insulin glargine (AmarylM + Lantus) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in HbA1c from baseline to the last visit
Measured: 16 weeks
Secondary outcomes (6)
Mean change in FPG, insulin, c-peptide from baseline to the last visit Safety; Episodes of hypoglycemia & other adverse events
Measured: 16 weeks
Response rate based on HbA1c and FPG levels measured at the last visit
Measured: 16 weeks
Mean change in Lantus® dose from baseline to the last visit
Measured: 16 weeks
Compliance
Measured: 16 weeks
Frequency with hypoglycemic episode
Measured: 16weeks
Adverse events
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2009 (estimated)
- Study startMay 2009
- Primary completionNov 2010
- Study completionNov 2010
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
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Handok Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Kang S Park, Principal investigator, Eulji University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00913367
- Sponsor's protocol ID
- HANDOK2008.10
- Status last verified
- Mar 2013
- First submitted
- 26 May 2009
- Last updated
- 28 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
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 Multi-center, Open, Randomized, Parallel-group, 2 Arm Study to Compare the Efficacy and Safety of Amaryl®M 1/500mg Twice Daily Versus Amaryl® 4mg Both in Combination With Lantus® Once-daily Regimen in Type 2 Diabetes Mellitus Patients With Inadequate Glycemic Control
- ClinicalTrials.gov ID
- NCT00913367
- Acronym / sponsor ID
- HANDOK2008.10
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Type 2 Diabetes Mellitus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Handok Inc.Industry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 4 Jun 2009 (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 compare the efficacy of Amaryl®M 1/500 mg twice daily versus Amaryl® 4 mg both in combination with Lantus® once-daily regimen in type 2 Diabetes Mellitus patients with inadequate glycemic control.
Detailed description
There are several kinds of oral antidiabetic drugs (OADs) that are used in the treatment of patients with type 2 DM. Among them, sulfonylurea and metformin are well-established first-line OADs. However, as the beta cell dysfunction progresses over time, patients fail to achieve good glycemic control with OADs alone and need further treatment intensification, usually involving the introduction of insulin either alone or in combination with OADs. Now, an OAD combined with bedtime insulin is one of the recommended treatment options for patients with type 2 DM and OAD failure. But, it still remains unclear which OADs are the most effective in combination with insulin for the treatment of type 2 DM.
so, this study we will be able to verify which OADs are the most effective in combination with insulin for the treatment of type 2 DM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amaryl group | Active comparator | Drug: glimepiride + insulin glargine (Amaryl + Lantus) |
| Amaryl M group | Experimental | Drug: glimepiride/metformin fixed combination+insulin glargine (AmarylM + Lantus) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients over 20 years old with type 2 DM
- Patients with inadequate glycemic control despite continuous use of tolerable or maximal doses of one or more OADs for 3months or more.
- 7%<HbA1c<11 % at screening
- 21 kg/m2 ≤ BMI ≤ 30 kg/m2
- Patents who need insulin add-on therapy based on investigator's discretion
Key exclusion criteria (10 listed)
- History of acute metabolic complications such as diabetic ketoacidosis or hyperosmolar nonketotic coma within 3 months before screening
- Pregnant or lactating females
- History of drug or alcohol abuse
- Patients with known hypersensitivity to glimepiride, metformin HCL or insulin
- Night-shift workers
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 + insulin glargine (Amaryl + Lantus)Also: Amaryl, Lantus injection solostar* Amaryl® 4 mg at breakfast + Lantus® at dinner * The initial dose of Lantus® is 0.2IU/kg at baseline. Lantus® titration will be made by patients every 3 days based on the mean value of previous 3 fasting SMBG level before breakfast | Drug | Amaryl group |
| glimepiride/metformin fixed combination+insulin glargine (AmarylM + Lantus)Also: Amaryl M, Lantus injection solostar* Amaryl® M 1/500 mg at breakfast + Amaryl® M 1/500 mg at dinner + Lantus® at dinner * The initial dose of Lantus® is 0.2IU/kg at baseline. Lantus® titration will be made by patients every 3 days based on the mean value of previous 3 fasting SMBG level before breakfast | Drug | Amaryl M group |
Primary outcome
Mean change in HbA1c from baseline to the last visit
Time frame: 16 weeks
6 secondary outcomes
Mean change in FPG, insulin, c-peptide from baseline to the last visit Safety; Episodes of hypoglycemia & other adverse events
Time frame: 16 weeks
Response rate based on HbA1c and FPG levels measured at the last visit
Time frame: 16 weeks
Mean change in Lantus® dose from baseline to the last visit
Time frame: 16 weeks
Compliance
Time frame: 16 weeks
Frequency with hypoglycemic episode
Time frame: 16weeks
Adverse events
Time frame: 16 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.
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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.
Kang S Park principal investigator
Eulji University 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 + insulin glargine (Amaryl + Lantus) and glimepiride/metformin fixed combination+insulin glargine (AmarylM + Lantus) 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 7 inclusion and 10 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?
Mean change in HbA1c from baseline to the last visit (time frame: 16 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 28 Mar 2013.