Type 2 Diabetes MellitusPhase 4NCT00975065
Galvus on Met Phase 4 Study : Study to Evaluate the Efficacy and Safety of Early Combination of Vildagliptin and Metformin in Patients With Type 2 Diabetes Mellitus
A Phase 4 study testing vildagliptin 50 mg bid plus metformin 1500mg (Galvus+Diabex) and metformin 1500mg plus metformin 500mg or 1000mg (Diabex) 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 80 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- vildagliptin 50 mg bid plus metformin 1500mg (Galvus+Diabex) and metformin 1500mg plus metformin 500mg or 1000mg (Diabex)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 266 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2009to Apr 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Type 2 Diabetes Mellitus who were inadequately controlled (baseline A1c of 7.0~11.0%)on metformin monotherapy (1500mg metformin)for ≥ 2 months before baseline visit
- Age of 18-80 years
- Body Mass Index of 18-40 kg/m2
Who cannot join
- Type 1 of diabetes
- Myocardial Infarction, Unstable Angina, or Coronary Artery Bypass Graft within the previous 6 months
- Congestive Heart Failure (III or NYHA class IV)
- Liver disease such as cirrhosis or Chronic Active Hepatitis
- History of Lacticacidemia
- Use of any Oral Anti-diabetic Drug other than Metformin within the 2 months
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- Use of insulin before screening visit
- ALT or AST >3 times the upper limit of Normal range
- Creatinine >1.5 mg/dl
- Other situation (pregnant or lactating females, history of drug or alcohol abuse, night-shift workers, clinically significant laboratory abnormality on screening or any medical condition that would affect the completion or outcome of the study)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 24-week, Open-label, Randomized, Multi-center, Parallel-group Study to Evaluate the Efficacy and Safety of Early Combination of Vildagliptin and Metformin in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Prior Metformin Monotherapy in Comparison to up Titrating Metformin Dose.
The study design of this trial is open-label, randomized, multi-center, parallel-group study.
Read the detailed description
- The progressive nature of T2DM will require the use of combination therapy in many patients over time to achieve and maintain glycemic control. Early combination, compared with maximal dose of monotherapy, could be more effective in lowering glycemia with better tolerability.
- Vildagliptin is a new oral antidiabetic drug acting as a potent and selective inhibitor of dipeptidyl peptidase-4(DPP-4), the enzyme responsible for the rapid degradation of circulating glucagon-like peptide-1. Vildagliptin improves islet function by a mechanism of increasing plasma levels of the active forms of the incretin hormones, GLP-1 and GIP.
- Metformin improves hyperglycemia primarily through its suppression of hepatic gluconeogenesis as well as enhancement of peripheral glucose update. Metformin is the most commonly prescribed first-line antidiabetic drug worldwide, but due to the progressive worsening of blood glucose control during the natural history of type 2 diabetes, combination therapy usually becomes necessary.
- Thus their combination therapy with complimentary action mechanism could be as effective as up titration of monotherapy.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- vildagliptin 50 mg bid plus metformin 1500mg (Galvus+Diabex), metformin 1500mg plus metformin 500mg or 1000mg (Diabex)
- Keywords
- Galvus
- 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.
vildagliptin 50 mg bid plus metformin 1500mg (Galvus+Diabex)Drug
vildagliptin 50 mg bid plus metformin 1500mg
metformin 1500mg plus metformin 500mg or 1000mg (Diabex)Drug
metformin 1500mg plus metformin 500mg or 1000mg
| Study group | Role | What they receive |
|---|---|---|
| Galvus group | Experimental | the combination of metformin plus Vildagliptin:
* vildagliptin 50 mg bid plus metformin 1500mg
* Additional SU therapy(After 12th week only under the following conditions): If A1c is ≥ 7.0% or investigator determines that the patient have metabolic problems at 12th week of therapy, investigator can prescribe additional sulfonylurea(glimepiride) to the current therapy. Receives: Drug: vildagliptin 50 mg bid plus metformin 1500mg (Galvus+Diabex) |
| Diabex group | Active comparator | metformin alone arm:
* metformin 1500mg plus metformin 500mg or 1000mg
* Additional SU therapy(After 12th week only under the following conditions): If A1c is ≥ 7.0% or investigator determines that the patient have metabolic problems at 12th week of therapy, investigator can prescribe additional sulfonylurea(glimepiride) to the current therapy Receives: Drug: metformin 1500mg plus metformin 500mg or 1000mg (Diabex) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1c at 24 weeks
Measured: 32weeks
Secondary outcomes (6)
Hemoglobin A1c at 12 weeks
Measured: 32weeks
Fasting plasma glucose(Self Monitored Blood Glucose) at 24 week
Measured: 32weeks
2hours post-prandial plasma glucose(Self Monitored Blood Glucose) at 24 week
Measured: 32weeks
Fasting Lipid profiles at 24 week
Measured: 32weeks
Body weight at 24 week
Measured: 32weeks
Hypoglycemic events, Gastro-Intestinal events, other adverse events at each visit
Measured: 32weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2009 (estimated)
- Study startAug 2009
- Primary completionDec 2011
- Study completionApr 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
- 266 participants (actual)
Sponsor and investigators
- Lead sponsor
- Handok Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sei Hyun Baik, professor, Principal investigator, Korea University Guro Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00975065
- Sponsor's protocol ID
- CLAF237AKR03T
- Status last verified
- Aug 2012
- First submitted
- 9 Sep 2009
- 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 24-week, Open-label, Randomized, Multi-center, Parallel-group Study to Evaluate the Efficacy and Safety of Early Combination of Vildagliptin and Metformin in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Prior Metformin Monotherapy in Comparison to up Titrating Metformin Dose.
- ClinicalTrials.gov ID
- NCT00975065
- Acronym / sponsor ID
- CLAF237AKR03T
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Galvus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 266 participants (actual)
- Lead sponsor
- Handok Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 11 Sep 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 study design of this trial is open-label, randomized, multi-center, parallel-group study.
Detailed description
- The progressive nature of T2DM will require the use of combination therapy in many patients over time to achieve and maintain glycemic control. Early combination, compared with maximal dose of monotherapy, could be more effective in lowering glycemia with better tolerability.
- Vildagliptin is a new oral antidiabetic drug acting as a potent and selective inhibitor of dipeptidyl peptidase-4(DPP-4), the enzyme responsible for the rapid degradation of circulating glucagon-like peptide-1. Vildagliptin improves islet function by a mechanism of increasing plasma levels of the active forms of the incretin hormones, GLP-1 and GIP.
- Metformin improves hyperglycemia primarily through its suppression of hepatic gluconeogenesis as well as enhancement of peripheral glucose update. Metformin is the most commonly prescribed first-line antidiabetic drug worldwide, but due to the progressive worsening of blood glucose control during the natural history of type 2 diabetes, combination therapy usually becomes necessary.
- Thus their combination therapy with complimentary action mechanism could be as effective as up titration of monotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Galvus group | Experimental | Drug: vildagliptin 50 mg bid plus metformin 1500mg (Galvus+Diabex)the combination of metformin plus Vildagliptin: * vildagliptin 50 mg bid plus metformin 1500mg * Additional SU therapy(After 12th week only under the following conditions): If A1c is ≥ 7.0% or investigator determines that the patient have metabolic problems at 12th week of therapy, investigator can prescribe additional sulfonylurea(glimepiride) to the current therapy. |
| Diabex group | Active comparator | Drug: metformin 1500mg plus metformin 500mg or 1000mg (Diabex)metformin alone arm: * metformin 1500mg plus metformin 500mg or 1000mg * Additional SU therapy(After 12th week only under the following conditions): If A1c is ≥ 7.0% or investigator determines that the patient have metabolic problems at 12th week of therapy, investigator can prescribe additional sulfonylurea(glimepiride) to the current therapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with Type 2 Diabetes Mellitus who were inadequately controlled (baseline A1c of 7.0~11.0%)on metformin monotherapy (1500mg metformin)for ≥ 2 months before baseline visit
- Age of 18-80 years
- Body Mass Index of 18-40 kg/m2
Key exclusion criteria (10 listed)
- Type 1 of diabetes
- Myocardial Infarction, Unstable Angina, or Coronary Artery Bypass Graft within the previous 6 months
- Congestive Heart Failure (III or NYHA class IV)
- Liver disease such as cirrhosis or Chronic Active Hepatitis
- History of Lacticacidemia
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 |
|---|---|---|
| vildagliptin 50 mg bid plus metformin 1500mg (Galvus+Diabex)vildagliptin 50 mg bid plus metformin 1500mg | Drug | Galvus group |
| metformin 1500mg plus metformin 500mg or 1000mg (Diabex)metformin 1500mg plus metformin 500mg or 1000mg | Drug | Diabex group |
Primary outcome
Hemoglobin A1c at 24 weeks
Time frame: 32weeks
6 secondary outcomes
Hemoglobin A1c at 12 weeks
Time frame: 32weeks
Fasting plasma glucose(Self Monitored Blood Glucose) at 24 week
Time frame: 32weeks
2hours post-prandial plasma glucose(Self Monitored Blood Glucose) at 24 week
Time frame: 32weeks
Fasting Lipid profiles at 24 week
Time frame: 32weeks
Body weight at 24 week
Time frame: 32weeks
Hypoglycemic events, Gastro-Intestinal events, other adverse events at each visit
Time frame: 32weeks
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.
Sei Hyun Baik, professor principal investigator
Korea University Guro 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 vildagliptin 50 mg bid plus metformin 1500mg (Galvus+Diabex) and metformin 1500mg plus metformin 500mg or 1000mg (Diabex) 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 3 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 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?
Hemoglobin A1c at 24 weeks (time frame: 32weeks). 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.