Diabetes Mellitus, Type 2Phase 4NCT02480465
Efficacy and Safety of Lobeglitazone Versus Sitagliptin
A Phase 4 study testing Lobelitazone 0.5mg and Sitagliptin 100mg in people with Diabetes Mellitus, Type 2, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
Efficacy and Safety of Lobeglitazone versus Sitagliptin in inadequately controlled by Metformin alone Type 2 Diabetes mellitus Patients with Metabolic syndrome. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Lobelitazone 0.5mg and Sitagliptin 100mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2015to Mar 2017
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥19 years old
- Waist line: male ≥ 90cm, female ≥ 85cm
- Applied to 1 or more categories listed below (NCEP-ATP III)
- SBP ≥ 130mmHg and/or DBP ≥ 85mmHg and/or taking drug for BP control
- HDL-C: male < 40mg/dl, female < 50mg/dl and/or taking drug for HDL-C increase
- TG ≥ 150mg/dl and/or taking drug for TG control
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- At visit 1: Applied to 1 or more categories listed below
- Type 2 DM Patients who does not need stabilization period : 7% ≤ HbA1c ≤ 10%, if treated with Metformin ≥ 1000mg monotherapy at least 12 weeks prior to this study → Visit 3(Randomization)
- Type 2 DM Patients who need stabilization period : 7% ≤ HbA1c ≤ 10%, if not treated with Metformin ≥ 1000mg monotherapy at least 12 weeks prior to this study (Applied to 1 or more categories listed below) ① Drug Naïve ② Taking Metformin < 1000mg monotherapy and/or Taking Metformin < 12 weeks prior to this study ③ Taking OHA
- At visit 2(After 12 weeks of stabilization period): 7% ≤ HbA1c ≤ 10%
- Patients who signed informed consent form
Who cannot join
- Type 1 DM Patients or secondary DM
- Patients with ketoacidosis
- Patients with taking insulin > 7 days within 12 weeks
- Hypersensitive to biguanide and/or glitazone and/or DPP4-inhibitor
- Patients with taking corticosteroid > 7 days within 4 weeks
- Patients with lactic acidosis
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- Patients with galactose intolerance and/or Lapp lactase deficiency and/or glucose-galactose malabsorption
- Patients with innutrition and/or starvation and/or weakness and/or pituitary insufficiency and/or addisons disease
- History of malignant tumor within 5 years
- History of drug or alcohol abuse within 12 weeks
- Patients with congestive heart failure(NYHA class III~IV) or uncontrolled arrythmia within 6 months
- Patients with acute cardiovasvular disaese with 12 weeks
- Applied to 1 or more categories listed below
- AST and/or ALT ≥ 3*ULN
- Serum creatinine: male ≥ 1.5mg/dl, female ≥ 1.4mg/dl
- Hb < 10.5g/dl
- Women with pregnant, breast-feeding
- Childbearing age who don't use adequate contraception
- Patients who have participated in other clinical trials
- Not eligible to participate for the study at the discretion of investigator
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Korea University Anam Hospital
Seoul
Dong-sub Choi
About this study
Official title: Efficacy and Safety of Lobeglitazone Versus Sitagliptin in Inadequately Controlled by Metformin Alone Type 2 Diabetes Mellitus Patients With Metabolic Syndrome: 24-week, Multi-center, Randomized, Double-blind, Phase 4 Study
Efficacy and Safety of Lobeglitazone versus Sitagliptin in inadequately controlled by Metformin alone Type 2 Diabetes mellitus Patients with Metabolic syndrome.
Read the detailed description
Efficacy and Safety of Lobeglitazone versus Sitagliptin in inadequately controlled by Metformin alone Type 2 Diabetes mellitus Patients with Metabolic syndrome: 24-week, Multi-center, Randomized, Double-blind, Phase 4 Study.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Lobelitazone 0.5mg, Sitagliptin 100mg
- 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.
Lobelitazone 0.5mgDrug
Lobelitazone 0.5mg, placebo of Sitagliptin 100mg, orally, 2 tablet once a day for 24 weeks with metformin
Sitagliptin 100mgDrug
placebo of Lobelitazone 0.5mg, Sitagliptin 100mg, orally, 2 tablet once a day for 24 weeks with metformin
| Study group | Role | What they receive |
|---|---|---|
| Lobelitazone 0.5mg | Experimental | Lobelitazone 0.5mg Receives: Drug: Lobelitazone 0.5mg |
| Sitagliptin 100mg | Active comparator | Sitagliptin 100mg Receives: Drug: Sitagliptin 100mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean percent change of HbA1c
Measured: from baseline at 24 weeks
Secondary outcomes (8)
The rate of Metabolic Syndrome
Measured: from baseline at 24 weeks
The mean percent change of Metabolic Syndrome Components(HDL-C, TG, BP, waist line)
Measured: from baseline at 24 weeks
The mean percent change of Glycemic parameters(FPG, HOMA-IR, HOMA- β, QUICKI)
Measured: from baseline at 24 weeks
The mean percent change of Lipid parameters(Total Cholesterol, LDL-C, HDL-C, Small Dense LDL-C, FFA, Apo-B)
Measured: from baseline at 24 weeks
The achivement rate of HbA1c(HbA1c < 6.5%, HbA1c < 7%)
Measured: from baseline at 24 weeks
The mean percent change of Adiponectin
Measured: from baseline at 24 weeks
The mean percent change of hs-CRP
Measured: from baseline at 24 weeks
Safety evaluation - physical examination, vital sign, laboratory, adverse event
Measured: from baseline at 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2016 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Chong Kun Dang PharmaceuticalThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 248 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dong-Sub Choi, Principal investigator, Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02480465
- Sponsor's protocol ID
- 39DM14010
- Status last verified
- May 2015
- First submitted
- 22 Jun 2015
- Last updated
- 8 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Lobeglitazone Versus Sitagliptin in Inadequately Controlled by Metformin Alone Type 2 Diabetes Mellitus Patients With Metabolic Syndrome: 24-week, Multi-center, Randomized, Double-blind, Phase 4 Study
- ClinicalTrials.gov ID
- NCT02480465
- Acronym / sponsor ID
- 39DM14010
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 248 participants (estimated)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 24 Jun 2015 (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.
Efficacy and Safety of Lobeglitazone versus Sitagliptin in inadequately controlled by Metformin alone Type 2 Diabetes mellitus Patients with Metabolic syndrome.
Detailed description
Efficacy and Safety of Lobeglitazone versus Sitagliptin in inadequately controlled by Metformin alone Type 2 Diabetes mellitus Patients with Metabolic syndrome: 24-week, Multi-center, Randomized, Double-blind, Phase 4 Study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lobelitazone 0.5mg | Experimental | Drug: Lobelitazone 0.5mgLobelitazone 0.5mg |
| Sitagliptin 100mg | Active comparator | Drug: Sitagliptin 100mgSitagliptin 100mg |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- ≥19 years old
- Waist line: male ≥ 90cm, female ≥ 85cm
- Applied to 1 or more categories listed below (NCEP-ATP III)
- At visit 1: Applied to 1 or more categories listed below
- At visit 2(After 12 weeks of stabilization period): 7% ≤ HbA1c ≤ 10%
Key exclusion criteria (20 listed)
- Type 1 DM Patients or secondary DM
- Patients with ketoacidosis
- Patients with taking insulin > 7 days within 12 weeks
- Hypersensitive to biguanide and/or glitazone and/or DPP4-inhibitor
- Patients with taking corticosteroid > 7 days within 4 weeks
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 |
|---|---|---|
| Lobelitazone 0.5mgLobelitazone 0.5mg, placebo of Sitagliptin 100mg, orally, 2 tablet once a day for 24 weeks with metformin | Drug | Lobelitazone 0.5mg |
| Sitagliptin 100mgplacebo of Lobelitazone 0.5mg, Sitagliptin 100mg, orally, 2 tablet once a day for 24 weeks with metformin | Drug | Sitagliptin 100mg |
Primary outcome
The mean percent change of HbA1c
Time frame: from baseline at 24 weeks
8 secondary outcomes
The rate of Metabolic Syndrome
Time frame: from baseline at 24 weeks
The mean percent change of Metabolic Syndrome Components(HDL-C, TG, BP, waist line)
Time frame: from baseline at 24 weeks
The mean percent change of Glycemic parameters(FPG, HOMA-IR, HOMA- β, QUICKI)
Time frame: from baseline at 24 weeks
The mean percent change of Lipid parameters(Total Cholesterol, LDL-C, HDL-C, Small Dense LDL-C, FFA, Apo-B)
Time frame: from baseline at 24 weeks
The achivement rate of HbA1c(HbA1c < 6.5%, HbA1c < 7%)
Time frame: from baseline at 24 weeks
The mean percent change of Adiponectin
Time frame: from baseline at 24 weeks
The mean percent change of hs-CRP
Time frame: from baseline at 24 weeks
Safety evaluation - physical examination, vital sign, laboratory, adverse event
Time frame: from baseline at 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2015.
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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-Sub 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 Lobelitazone 0.5mg and Sitagliptin 100mg in people with Diabetes Mellitus, Type 2, run by Chong Kun Dang Pharmaceutical 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 11 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 8 Jul 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hyun-Kyung Oh (82-2-2194-0469, hkoh@ckdpharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mean percent change of HbA1c (time frame: from baseline at 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 8 Jul 2015.