Type2 DiabetesPhase 3NCT03627182
Efficacy and Safety of CKD-501 Added to D150 Plus D745 25mg Therapy in Patients With Type 2 Diabetes
A Phase 3 study testing CKD-501 0.5mg in people with Type2 Diabetes, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
The purpose of this study is to prove that the group treated with CKD-501 in combination added that the reduction of glycated hemoglobin superior to placebo treated group added in combination. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Type2 Diabetes
- What is being tested?
- CKD-501 0.5mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 Apr 2018to 10 Feb 2023
- 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 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between 19 years and 75 years old(male or female)
- Type Ⅱ diabetes mellitus
- The patient who has been taking oral hypoglycemic agent at least 8weeks with HbA1c 7 to 10% at screening test
- Body Mass Index between 21kg/㎡ and 40kg/㎡
- C-peptide > 1.0 ng/ml
- Agreement with written informed consent
- HbA1c 7 to 10% after Run-in period
Who cannot join
- Type I diabetes or secondary diabetes
- Continuous or non continuous treatment(over 7 days) insulin within 3 months prior to screening
- Treatment with Thiazolidinedione within 3months or patient who has experience such as hypersensitivity reaction, serious adverse event with Thiazolidinedione(TZD), sodium glucose cotransporter 2(SGLT2) inhibitor, Biguanide.
- Chronic(continuous over 7 days) oral or non oral corticosteroids treatment within 1 month prior to screening
- Treatment with anti-obesity drugs within 3months
- Past history: lactic acidosis, genetic problem such as galactose intolerance, etc.
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- Acute or chronic metabolic acidosis including diabetic ketoacidosis
- History of proliferative diabetic retinopathy
- Patient with severe infection, severe injury
- Patients with urinary tract infection including urinary tract sepsis and pyelonephritis
- Malnutrition, weakness, starvation, hyposthenia, pituitary insufficiency or adrenal insufficiency
- History of malignant tumor within 5years
- Drug abuse or history of alcoholism
- Severe pulmonary dysfunction
- Severe GI disorder
- History of myocardial infarction, heart failure, cerebral infarction, cerebral hemorrhage or unstable angina within 6 months
- Abnormal lab result: ① Fasting Plasma Glucose > 270 mg/dl ② Triglyceride ≥ 500 mg/dl ③ Significant liver dysfunction or AST(Aspartate transaminase)/ALT(Alanine transaminase) ≥ normal range*3 or Total bilirubin ≥ normal range*2 ④ Hemoglobin<10.5g/dL ⑤ Abnormality of thyroid function(significantly out of normal TSH(Thyroid Stimulating Hormone) range)
- eGFR(Estimated glomerular filtration rate) is less than 60ml/min/1.73m^2
- Pregnant women or nursing mothers
- Fertile women who not practice contraception with appropriate methods
- Participated in other trial within 4 weeks or participating in other trial at present
- In investigator's judgment
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Severance Hospital, Yonsei University Health System
Seoul
BongSoo Cha, Ph.D, 82-2-2228-1962, bscha@yuhs.ac
About this study
Official title: Efficacy and Safety of CKD-501 Added to D150 Plus D745 25mg Therapy in Patients With Type 2 Diabetes Inadequately Controlled With D150 Plus D745 25mg: Multi-center, Randomized, Double-blind, Parallel-group, Placebo Control, Therapeutic Confirmatory Study.
The purpose of this study is to prove that the group treated with CKD-501 in combination added that the reduction of glycated hemoglobin superior to placebo treated group added in combination.
Read the detailed description
The aim of this phase III study was to evaluate the efficacy and safety of additional combined CKD-501 administration for 24 weeks in patients with type 2 diabetes who were not adequately controlled for blood glucose by the combination of D150 and D745 25mg .
Furthermore, the extension study for additional 28 weeks is designed to confirm long term safety of actual drug as an oral hypoglycemic agent.
- Conditions
- Type2 Diabetes
- Being tested
- CKD-501 0.5mg, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CKD-501 0.5mgDrug
Also called Lobeglitazone 0.5mg
CKD-501 0.5mg, orally, 1 tablet once a day for 24weeks or 52weeks(if extension study) with D150 and D745
PlaceboDrug
Placebo, orally, 1 tablet once a day for 24weeks with D150 and D745.
CKD-501 placebo will be changed to CKD-501 from extension stydy to EOS(end of study).
| Study group | Role | What they receive |
|---|---|---|
| CKD-501 0.5mg | Experimental | CKD-501 0.5mg Receives: Drug: CKD-501 0.5mg |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Glycosylated Hemoglobin (HbA1c)
Measured: Baseline, 24 weeks
Secondary outcomes (17)
Change from baseline in Glycosylated Hemoglobin (HbA1c)
Measured: Baseline, 52 weeks
Change from baseline in Fasting plasma glucose
Measured: Baseline, 24 weeks, 52 weeks
Change from baseline in HOMA-IR(Homeostasis Model Assessment of Insulin Resistance)
Measured: Baseline, 24 weeks, 52 weeks
Change from baseline in HOMA-β(Homeostasis Model Assessment of β-cell function)
Measured: Baseline, 24 weeks, 52 weeks
Change from baseline in QUICKI(Quantitative Insulin Check Index)
Measured: Baseline, 24 weeks, 52 weeks
HbA1c target achievement rate at 24 weeks(HbA1c < 6.5%, 7%)
Measured: Baseline, 24 weeks, 52 weeks
Change from baseline in Total Cholesterol
Measured: Baseline, 24 weeks, 52 weeks
Change from baseline in Triglycerides
Measured: Baseline, 24 weeks, 52 weeks
Change from baseline in LDL-Cholesterol
Measured: Baseline, 24 weeks, 52 weeks
Change from baseline in HDL-Cholesterol
Measured: Baseline, 24 weeks, 52 weeks
Change from baseline in non-HDL-Cholesterol
Measured: Baseline, 24 weeks, 52 weeks
Change from baseline in Small Dense LDL-Cholesterol
Measured: Baseline, 24 weeks, 52 weeks
Change from baseline in FFA(Free Fatty Acid)
Measured: Baseline, 24 weeks, 52 weeks
Change from baseline in Apo-AⅠ
Measured: Baseline, 24 weeks, 52 weeks
Change from baseline in Apo-B
Measured: Baseline, 24 weeks, 52 weeks
Change from baseline in Apo-CⅢ
Measured: Baseline, 24 weeks, 52 weeks
Evaluate safety of CKD-501 from number of participants with adverse events
Measured: Baseline, 24 weeks, 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2018
- Study start26 Apr 2018
- Primary completion29 Mar 2022 (estimated)
- Study completion10 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2 DiabetesStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- BongSoo Cha, Ph.D, Principal investigator, Severance Hospital, Yonsei University Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03627182
- Sponsor's protocol ID
- 19DM17015
- Status last verified
- Jun 2018
- First submitted
- 4 Jul 2018
- Last updated
- 13 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of CKD-501 Added to D150 Plus D745 25mg Therapy in Patients With Type 2 Diabetes Inadequately Controlled With D150 Plus D745 25mg: Multi-center, Randomized, Double-blind, Parallel-group, Placebo Control, Therapeutic Confirmatory Study.
- ClinicalTrials.gov ID
- NCT03627182
- Acronym / sponsor ID
- 19DM17015
- Conditions
- Type2 Diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 26 Apr 2018 (actual)
- Primary completion
- 29 Mar 2022 (estimated)
- Study completion
- 10 Feb 2023 (estimated)
- First posted
- 13 Aug 2018 (actual)
- 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 prove that the group treated with CKD-501 in combination added that the reduction of glycated hemoglobin superior to placebo treated group added in combination.
Detailed description
The aim of this phase III study was to evaluate the efficacy and safety of additional combined CKD-501 administration for 24 weeks in patients with type 2 diabetes who were not adequately controlled for blood glucose by the combination of D150 and D745 25mg .
Furthermore, the extension study for additional 28 weeks is designed to confirm long term safety of actual drug as an oral hypoglycemic agent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CKD-501 0.5mg | Experimental | Drug: CKD-501 0.5mgCKD-501 0.5mg |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Between 19 years and 75 years old(male or female)
- Type Ⅱ diabetes mellitus
- The patient who has been taking oral hypoglycemic agent at least 8weeks with HbA1c 7 to 10% at screening test
- Body Mass Index between 21kg/㎡ and 40kg/㎡
- C-peptide > 1.0 ng/ml
Key exclusion criteria (22 listed)
- Type I diabetes or secondary diabetes
- Continuous or non continuous treatment(over 7 days) insulin within 3 months prior to screening
- Treatment with Thiazolidinedione within 3months or patient who has experience such as hypersensitivity reaction, serious adverse event with Thiazolidinedione(TZD), sodium glucose cotransporter 2(SGLT2) inhibitor, Biguanide.
- Chronic(continuous over 7 days) oral or non oral corticosteroids treatment within 1 month prior to screening
- Treatment with anti-obesity drugs within 3months
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 |
|---|---|---|
| CKD-501 0.5mgAlso: Lobeglitazone 0.5mgCKD-501 0.5mg, orally, 1 tablet once a day for 24weeks or 52weeks(if extension study) with D150 and D745 | Drug | CKD-501 0.5mg |
| PlaceboPlacebo, orally, 1 tablet once a day for 24weeks with D150 and D745. CKD-501 placebo will be changed to CKD-501 from extension stydy to EOS(end of study). | Drug | Placebo |
Primary outcome
Change from baseline in Glycosylated Hemoglobin (HbA1c)
Time frame: Baseline, 24 weeks
17 secondary outcomes
Change from baseline in Glycosylated Hemoglobin (HbA1c)
Time frame: Baseline, 52 weeks
Change from baseline in Fasting plasma glucose
Time frame: Baseline, 24 weeks, 52 weeks
Change from baseline in HOMA-IR(Homeostasis Model Assessment of Insulin Resistance)
Time frame: Baseline, 24 weeks, 52 weeks
Change from baseline in HOMA-β(Homeostasis Model Assessment of β-cell function)
Time frame: Baseline, 24 weeks, 52 weeks
Change from baseline in QUICKI(Quantitative Insulin Check Index)
Time frame: Baseline, 24 weeks, 52 weeks
HbA1c target achievement rate at 24 weeks(HbA1c < 6.5%, 7%)
Time frame: Baseline, 24 weeks, 52 weeks
Change from baseline in Total Cholesterol
Time frame: Baseline, 24 weeks, 52 weeks
Change from baseline in Triglycerides
Time frame: Baseline, 24 weeks, 52 weeks
Change from baseline in LDL-Cholesterol
Time frame: Baseline, 24 weeks, 52 weeks
Change from baseline in HDL-Cholesterol
Time frame: Baseline, 24 weeks, 52 weeks
Change from baseline in non-HDL-Cholesterol
Time frame: Baseline, 24 weeks, 52 weeks
Change from baseline in Small Dense LDL-Cholesterol
Time frame: Baseline, 24 weeks, 52 weeks
Change from baseline in FFA(Free Fatty Acid)
Time frame: Baseline, 24 weeks, 52 weeks
Change from baseline in Apo-AⅠ
Time frame: Baseline, 24 weeks, 52 weeks
Change from baseline in Apo-B
Time frame: Baseline, 24 weeks, 52 weeks
Change from baseline in Apo-CⅢ
Time frame: Baseline, 24 weeks, 52 weeks
Evaluate safety of CKD-501 from number of participants with adverse events
Time frame: Baseline, 24 weeks, 52 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2018.
- Individual participant dataSharing planned: No
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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.
BongSoo Cha, Ph.D principal investigator
Severance Hospital, Yonsei University Health System
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 CKD-501 0.5mg in people with Type2 Diabetes, 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 7 inclusion and 22 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 13 Aug 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact BongSoo Cha, Ph.D (82-2-2228-1962, bscha@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Glycosylated Hemoglobin (HbA1c) (time frame: Baseline, 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 13 Aug 2018.