Type 2 Diabetes MellitusPhase 3NCT01601990
Phase 3 Trial to Evaluate the Efficacy and Safety of LC15-0444 in Patients With Type 2 Diabetes
A Phase 3 study testing LC15-0444 50mg qd in people with Type 2 Diabetes Mellitus, run by LG Life Sciences at 1 site in South Korea.
Trial summary
Double-blind, randomized, multicenter, multinational (South Korea and India), parallel group study The study was divided into three parts: part 1 was started with an initial 2 weeks of exercise/diet program followed by another 2 weeks of single-blind placebo run-in period; part 2 was a double-blind treatment period… 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?
- LC15-0444 50mg qd
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 189 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2009to Nov 2011
- Phase
- Phase 3
- 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 with Type 2 Diabetes Mellitus
- Adults between 18 and 75 of age
- Patients with HbA1c between 7 % and 11 %
- Patient who had not received any diabetic medications within 6 weeks from screening
- Patients who signed on the consent form after informed on the object, method, and risks of the clinical study
Who cannot join
- Patients with type 1 diabetes mellitus, gestational diabetes, or secondary diabetes
- Patients who were taking or needed to take any drugs which may affect the control of blood glucose significantly (ex. glucocorticoids)
- Patients who had experienced myocardial infarction, unstable angina or prior history of coronary artery bypass surgery within 6 months prior to screening, or patients with arrhythmia requiring treatment
- Patients with NYHA class II-IV congestive heart failure
- Patients with history of hepatic cirrhosis
- Patients with renal failure or whose creatinine clearance was less than 60mL/min
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- Patients with dysfunctional thyroid gland (with abnormal level of TSH)
- Patients with ALT, AST or CPK exceeding 2.5 times of the upper limit of the normal range
- Patients with BMI below 20 kg/m2 or exceeding 40 kg/m2
- Patients with history of asthma or major skin allergy
- Patients taking thyroid hormone, warfarin, dicoumarin or digoxin.
- Patients with history of hypersensitivity to metformin or biguanides.
- Patients who took sodium channel blockers in the last 6 weeks prior to Visit 1.
- Patients who were treated with insulin or glucagon-like peptide-1 (GLP-1) analogue or who took thiazolidinediones (Glitazone) in the last 6 months prior to Visit 1.
- Patients with other reasons who the investigator decided not to be eligible for the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Multinational, Randomized, Placebo-controlled, Parallel Group, Double-blind, Phase 3 Trial to Evaluate the Efficacy and Safety of LC15-0444 in Patients With Type 2 Diabetes
Double-blind, randomized, multicenter, multinational (South Korea and India), parallel group study The study was divided into three parts: part 1 was started with an initial 2 weeks of exercise/diet program followed by another 2 weeks of single-blind placebo run-in period; part 2 was a double-blind treatment period during which eligible patients were randomized to LC15-0444 50mg or placebo groups and received the assigned treatment for 24 weeks; part 3 was for those patients who completed part 1 \& 2 and consented to receive another 28 weeks of treatment with LC15-0444 50mg. Screening tests were performed on the patients who had given the written informed consent. After 2-week exercise/diet program according to the generally recognized guideline, patients took placebo for another 2 weeks while continuing exercise/diet program. When the 2-week placebo run-in period was completed, eligible patients were assigned either to placebo or 50 mg of LC15-0444 with 1:1 ratio. During the total of 24- week treatment period of part 2 after randomization, each patient visited the investigational site at Week 6, 12, 18, and 24. Completing treatment with placebo or LC15-0444 50mg for 24 weeks after randomization, each patient was asked to provide consent to participate in the part 3 of the study where all the patients were to receive LC15-0444 50mg regardless of the treatment received during the part 2 of the study. During 28-week treatment period of the part 3, each patient visited the investigational site at Week 30, 38, 46, and 52. Total study period from screening was 56 weeks per each patient.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Placebo group(once daily), LC15-0444 50mg qd
- 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.
Placebo group(once daily)Drug
eligible patients were randomized to LC15-0444 50mg or placebo groups and received the assigned treatment for 24 weeks.
LC15-0444 50mg qdDrug
eligible patients were randomized to LC15-0444 50mg or placebo groups and received the assigned treatment for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo group(once daily) |
| LC15-0444 | Experimental | Not described Receives: Drug: LC15-0444 50mg qd |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of HbAlc
Measured: from baseline to Week 24
Secondary outcomes (1)
HbA1c Responder Rate
HbA1c Responder Rate at Week 24: HbA1c <7 %, <6.5 %
Measured: at Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2012 (estimated)
- Study startDec 2009
- Primary completionMar 2011
- Study completionNov 2011
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- LG Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Se Hyun Baek, MD, PhD, Principal investigator, Korea University Guro Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01601990
- Sponsor's protocol ID
- LG-DPCL005
- Status last verified
- May 2012
- First submitted
- 15 May 2012
- Last updated
- 18 May 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Multinational, Randomized, Placebo-controlled, Parallel Group, Double-blind, Phase 3 Trial to Evaluate the Efficacy and Safety of LC15-0444 in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01601990
- Acronym / sponsor ID
- LG-DPCL005
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- LG Life SciencesIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 18 May 2012 (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.
Double-blind, randomized, multicenter, multinational (South Korea and India), parallel group study The study was divided into three parts: part 1 was started with an initial 2 weeks of exercise/diet program followed by another 2 weeks of single-blind placebo run-in period; part 2 was a double-blind treatment period during which eligible patients were randomized to LC15-0444 50mg or placebo groups and received the assigned treatment for 24 weeks; part 3 was for those patients who completed part 1 \& 2 and consented to receive another 28 weeks of treatment with LC15-0444 50mg. Screening tests were performed on the patients who had given the written informed consent. After 2-week exercise/diet program according to the generally recognized guideline, patients took placebo for another 2 weeks while continuing exercise/diet program. When the 2-week placebo run-in period was completed, eligible patients were assigned either to placebo or 50 mg of LC15-0444 with 1:1 ratio. During the total of 24- week treatment period of part 2 after randomization, each patient visited the investigational site at Week 6, 12, 18, and 24. Completing treatment with placebo or LC15-0444 50mg for 24 weeks after randomization, each patient was asked to provide consent to participate in the part 3 of the study where all the patients were to receive LC15-0444 50mg regardless of the treatment received during the part 2 of the study. During 28-week treatment period of the part 3, each patient visited the investigational site at Week 30, 38, 46, and 52. Total study period from screening was 56 weeks per each patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo group(once daily) |
| LC15-0444 | Experimental | Drug: LC15-0444 50mg qd |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with Type 2 Diabetes Mellitus
- Adults between 18 and 75 of age
- Patients with HbA1c between 7 % and 11 %
- Patient who had not received any diabetic medications within 6 weeks from screening
- Patients who signed on the consent form after informed on the object, method, and risks of the clinical study
Key exclusion criteria (15 listed)
- Patients with type 1 diabetes mellitus, gestational diabetes, or secondary diabetes
- Patients who were taking or needed to take any drugs which may affect the control of blood glucose significantly (ex. glucocorticoids)
- Patients who had experienced myocardial infarction, unstable angina or prior history of coronary artery bypass surgery within 6 months prior to screening, or patients with arrhythmia requiring treatment
- Patients with NYHA class II-IV congestive heart failure
- Patients with history of hepatic cirrhosis
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 |
|---|---|---|
| Placebo group(once daily)eligible patients were randomized to LC15-0444 50mg or placebo groups and received the assigned treatment for 24 weeks. | Drug | Placebo |
| LC15-0444 50mg qdeligible patients were randomized to LC15-0444 50mg or placebo groups and received the assigned treatment for 24 weeks | Drug | LC15-0444 |
Primary outcome
Change of HbAlc
Time frame: from baseline to Week 24
1 secondary outcome
HbA1c Responder Rate
Time frame: at Week 24
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 18 May 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.
Se Hyun Baek, MD, PhD 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 3 study testing LC15-0444 50mg qd in people with Type 2 Diabetes Mellitus, run by LG Life Sciences 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 5 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 18 May 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Change of HbAlc (time frame: from baseline to Week 24). 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 18 May 2012; AzTrials last refreshed its copy on 6 Nov 2026.