Type2 DiabetesPhase 3NCT03641352
The Efficacy and Safety of CKD-501 Added to D150 Plus D759 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 80 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
- 2 May 2018to 30 Nov 2022
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- between 19 years and 80 years old(male or female)
- Type 2 diabetes mellitus
- The patient who has been taking oral hypoglycemic agent at least 8weeks with HbA1c 7 to 10% at screening test
- BMI between 21kg/m2 and 40kg/m2
- C-peptide ≥ 1.0 ng/ml
- Agreement with written informed consent
- HbA1c 7 to 10% after Run-in period
Who cannot join
- Type 1 diabetes mellitus or secondary diabetes mellitus
- Continuous or non continuous treatment(over 7 days) insulin within 3 months prior to screening
- Treatment with Thiazolidinedione(TZD) within 3 months or patient who has experience such as hypersensitivity reaction, serious adverse event with TZD, Biguanide
- Chronic(continuous over 7 days) oral or non oral corticosteroids treatment within 1 month prior to screening
- Treatment with anti-obesity drugs within 3 months
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
The Catholic University of Korea, Seoul ST. Mary's Hospital
Seoul
kun ho yoon, Ph.D, 82-2-2258-6007
About this study
Official title: The Efficacy and Safety of CKD-501 Added to D150 Plus D759 Therapy in Patients With Type 2 Diabetes Inadequately Controlled With D150 Plus D759, Randomized, Double-blind, Multi-center, 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 3 study was to evaluate the efficacy and safety of additional combined CKD-501 administration for 24 weeks in patient with type 2 diabetes who were nao adequately controlled for blood glucose by the combination of D150 and D759
- 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
CKD-501 0.5mg, orally, 1 tablet once a dqy for 24weeks or 52weeks (if extension study) with D150 and D759
PlaceboDrug
Placebo, orally, 1 tablet once a dqy for 24weeks or 52weeks (if extension study) with D150 and D759. CKD-501 placebo will be changed to CKD-501 from extension study 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
Measured: Baseline, 24weeks
Secondary outcomes (17)
Change from baseline in in Glycosylated Hemoglobin
Measured: Baseline, 52weekes
Change from baseline in Fasting plasma glucose
Measured: Baseline, 24weeks, 52weeks
HbA1c target achievement rate at 24weekes(HbA1c < 6.5%, 7%)
Measured: Baseline, 24weeks
Change from baseline in Total Cholesterol
Measured: Baseline, 24weeks, 52weeks
Evaluate safety of CKD-501 from number of participants with adverse events
Measured: Baseline, 24weeks, 52weeks
Change from baseline in HOMA-IR(Homeostasis Model Assessment of Insulin Resistance)
Measured: Baseline, 24weeks, 52weeks
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
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-B
Measured: Baseline, 24 weeks, 52 weeks
Change from baseline in Apo-CⅢ
Measured: Baseline, 24 weeks, 52 weeks
Change from baseline in Apo-AⅠ
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 posted22 Aug 2018
- Study start2 May 2018
- Primary completion30 Apr 2021 (estimated)
- Study completion30 Nov 2022 (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
- Kun ho Yoon, Ph.D, Principal investigator, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03641352
- Sponsor's protocol ID
- 19DM17012
- Status last verified
- Aug 2018
- First submitted
- 20 Jul 2018
- Last updated
- 22 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 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of CKD-501 Added to D150 Plus D759 Therapy in Patients With Type 2 Diabetes Inadequately Controlled With D150 Plus D759, Randomized, Double-blind, Multi-center, Parallel-group, Placebo Control, Therapeutic Confirmatory Study
- ClinicalTrials.gov ID
- NCT03641352
- Acronym / sponsor ID
- 19DM17012
- 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
- 2 May 2018 (actual)
- Primary completion
- 30 Apr 2021 (estimated)
- Study completion
- 30 Nov 2022 (estimated)
- First posted
- 22 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 3 study was to evaluate the efficacy and safety of additional combined CKD-501 administration for 24 weeks in patient with type 2 diabetes who were nao adequately controlled for blood glucose by the combination of D150 and D759
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 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- between 19 years and 80 years old(male or female)
- Type 2 diabetes mellitus
- The patient who has been taking oral hypoglycemic agent at least 8weeks with HbA1c 7 to 10% at screening test
- BMI between 21kg/m2 and 40kg/m2
- C-peptide ≥ 1.0 ng/ml
Key exclusion criteria (5 listed)
- Type 1 diabetes mellitus or secondary diabetes mellitus
- Continuous or non continuous treatment(over 7 days) insulin within 3 months prior to screening
- Treatment with Thiazolidinedione(TZD) within 3 months or patient who has experience such as hypersensitivity reaction, serious adverse event with TZD, Biguanide
- Chronic(continuous over 7 days) oral or non oral corticosteroids treatment within 1 month prior to screening
- Treatment with anti-obesity drugs within 3 months
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: LobeglitazoneCKD-501 0.5mg, orally, 1 tablet once a dqy for 24weeks or 52weeks (if extension study) with D150 and D759 | Drug | CKD-501 0.5mg |
| PlaceboPlacebo, orally, 1 tablet once a dqy for 24weeks or 52weeks (if extension study) with D150 and D759. CKD-501 placebo will be changed to CKD-501 from extension study to EOS(end of study). | Drug | Placebo |
Primary outcome
Change from baseline in Glycosylated Hemoglobin
Time frame: Baseline, 24weeks
17 secondary outcomes
Change from baseline in in Glycosylated Hemoglobin
Time frame: Baseline, 52weekes
Change from baseline in Fasting plasma glucose
Time frame: Baseline, 24weeks, 52weeks
HbA1c target achievement rate at 24weekes(HbA1c < 6.5%, 7%)
Time frame: Baseline, 24weeks
Change from baseline in Total Cholesterol
Time frame: Baseline, 24weeks, 52weeks
Evaluate safety of CKD-501 from number of participants with adverse events
Time frame: Baseline, 24weeks, 52weeks
Change from baseline in HOMA-IR(Homeostasis Model Assessment of Insulin Resistance)
Time frame: Baseline, 24weeks, 52weeks
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
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-B
Time frame: Baseline, 24 weeks, 52 weeks
Change from baseline in Apo-CⅢ
Time frame: Baseline, 24 weeks, 52 weeks
Change from baseline in Apo-AⅠ
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 22 Aug 2018.
- Individual participant dataSharing planned: No
Related trials for Type2 Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
Kun ho Yoon, Ph.D principal investigator
The Catholic University of Korea
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 5 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 22 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 Kun ho Yoon, Ph.D (82-2-2258-6007, yoonk@catholic.ac.kr), 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 (time frame: Baseline, 24weeks). 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 22 Aug 2018.