Type 2 Diabetes MellitusPhase 3NCT01106131
Efficacy and Safety of CKD-501 Versus Pioglitazone When Added to Metformin
A Phase 3 study testing CKD-501 0.5mg and Pioglitazone 15mg in people with Type 2 Diabetes Mellitus, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
The purpose of this study is to prove effect of glucose reduction that CKD-501 and metformin combination treatment group is non inferiority compare to pioglitazone and metformin combination. 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?
- CKD-501 0.5mg and Pioglitazone 15mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 253 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2010to Nov 2012
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between 18 years and 80 years old(male or female)
- Type Ⅱ diabetes mellitus
- The patient who has been taking oral hypoglycemic agent since 2 months with HbA1c 7 to 10% at screening test
- BMI between 21kg/㎡ and 40kg/㎡
- C-peptide level is over 1.0 ng/ml
- Agreement with written informed consent
Who cannot join
- Type I diabetes or secondary diabetes
- Continuous or non continuous treatment(over 7 days) insulin within 3 month prior to screening
- Treatment with thiazolidinediones within 60 days or patient who have experience such as hypersensitivity reaction, serious adverse event or no effect by treatment with glitazones
- Chronic(continuous over 7 days) oral or non oral corticosteroids treatment within 1 month prior to screening
- Past history: lactic acidosis or metformin contraindication
- Acute or chronic metabolic acidosis including diabetic ketoacidosis
Show all 24Show fewer
- History of proliferative diabetic retinopathy
- Severe infection, severe injury patients (pre and post operation)
- Oligotrophy,starvation, hyposthenia, pituitary insufficiency or capsular insufficiency
- Drug abuse or history of alcoholism
- History of myocardial infarction, heart failure, cerebral infarction, hematencephalon or unstable angina within 6 months
- Fasting Plasma Glucose level is over 270 mg/dl
- Triglyceride level is 500 mg/dl and over
- Significant abnormal liver dysfunction: AST, ALT level over or equal to 2.5 times, Total bilirubin level over or equal 2 times as high as upper normal limit(UNL)
- Significant abnormal renal dysfunction
- Anemia
- Abnormality of thyroid function(out of significant normal TSH range )
- Hepatitis B or C test is positive
- Pregnant women or nursing mothers
- Has a contraindication to treatment
- Fertile women who not practice contraception with appropriate methods
- Participated in other trial within 4 weeks
- Participating in other trial at present
- In investigator's judgment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of CKD-501 or Pioglitazone Added to Ongoing Metformin Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Alone: Multi Center, Randomized, Double Blind, Therapeutic Confirmatory Study
The purpose of this study is to prove effect of glucose reduction that CKD-501 and metformin combination treatment group is non inferiority compare to pioglitazone and metformin combination.
Read the detailed description
The aim of this phase 3 study was to evaluate the efficacy and safety of CKD-501 and metformin combination for 24 weeks in type 2 diabetes mellitus. Furthermore, the extension study for additional 28weeks is designed to confirm long term safety of CKD-501 as an oral hypoglycemic agent.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- CKD-501 0.5mg, Pioglitazone 15mg
- 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.
CKD-501 0.5mgDrug
Also called Lobeglitazone
CKD-501 0.5mg, orally, 1 tablet once a day for 24weeks or 52weeks(if extension study) with metformin.
Pioglitazone 15mgDrug
Pioglitazone 15mg, orally, 1 tablet or 2 tablet(if confirmed case) once a day for 24weeks with metformin.
| Study group | Role | What they receive |
|---|---|---|
| CKD-501 0.5mg | Experimental | Not described Receives: Drug: CKD-501 0.5mg |
| Pioglitazone 15mg | Active comparator | Not described Receives: Drug: Pioglitazone 15mg |
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 (4)
Change from baseline in glycemic parameters
Measured: Baseline, 24 weeks
Change from baseline in HbA1c target achievement rate (HbA1c < 7%)
Measured: Baseline, 24 weeks
Change from baseline in lipid parameters
Measured: Baseline, 24 weeks
Evaluate safety of CKD-501 from physical exam, vital sign, laboratory test, adverse events
Measured: Baseline, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2010 (estimated)
- Study startMay 2010
- Primary completionApr 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies 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
- 253 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- SungWoo Park, M.D., Ph.D., Study chair, Kangbuk Samsung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01106131
- Sponsor's protocol ID
- 19DM09F
- Status last verified
- Feb 2013
- First submitted
- 16 Apr 2010
- Last updated
- 15 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kim KS, Hong S, Ahn HY, Park CY. Comparative Efficacy of Lobeglitazone Versus Pioglitazone on Albuminuria in Patients with Type 2 Diabetes Mellitus. Diabetes Ther. 2021 Jan;12(1):171-181. doi: 10.1007/s13300-020-00948-1. Epub 2020 Oct 24.
PubMed 33099742
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of CKD-501 or Pioglitazone Added to Ongoing Metformin Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Alone: Multi Center, Randomized, Double Blind, Therapeutic Confirmatory Study
- ClinicalTrials.gov ID
- NCT01106131
- Acronym / sponsor ID
- 19DM09F
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 253 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 19 Apr 2010 (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 purpose of this study is to prove effect of glucose reduction that CKD-501 and metformin combination treatment group is non inferiority compare to pioglitazone and metformin combination.
Detailed description
The aim of this phase 3 study was to evaluate the efficacy and safety of CKD-501 and metformin combination for 24 weeks in type 2 diabetes mellitus. Furthermore, the extension study for additional 28weeks is designed to confirm long term safety of CKD-501 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 0.5mg |
| Pioglitazone 15mg | Active comparator | Drug: Pioglitazone 15mg |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Between 18 years and 80 years old(male or female)
- Type Ⅱ diabetes mellitus
- The patient who has been taking oral hypoglycemic agent since 2 months with HbA1c 7 to 10% at screening test
- BMI between 21kg/㎡ and 40kg/㎡
- C-peptide level is over 1.0 ng/ml
Key exclusion criteria (24 listed)
- Type I diabetes or secondary diabetes
- Continuous or non continuous treatment(over 7 days) insulin within 3 month prior to screening
- Treatment with thiazolidinediones within 60 days or patient who have experience such as hypersensitivity reaction, serious adverse event or no effect by treatment with glitazones
- Chronic(continuous over 7 days) oral or non oral corticosteroids treatment within 1 month prior to screening
- Past history: lactic acidosis or metformin contraindication
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 day for 24weeks or 52weeks(if extension study) with metformin. | Drug | CKD-501 0.5mg |
| Pioglitazone 15mgPioglitazone 15mg, orally, 1 tablet or 2 tablet(if confirmed case) once a day for 24weeks with metformin. | Drug | Pioglitazone 15mg |
Primary outcome
Change from baseline in Glycosylated Hemoglobin (HbA1c)
Time frame: Baseline, 24 weeks
4 secondary outcomes
Change from baseline in glycemic parameters
Time frame: Baseline, 24 weeks
Change from baseline in HbA1c target achievement rate (HbA1c < 7%)
Time frame: Baseline, 24 weeks
Change from baseline in lipid parameters
Time frame: Baseline, 24 weeks
Evaluate safety of CKD-501 from physical exam, vital sign, laboratory test, adverse events
Time frame: Baseline, 24 weeks
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 15 Feb 2013.
- Derived from this study: PubMed 33099742Kim KS, Hong S, Ahn HY, Park CY. Comparative Efficacy of Lobeglitazone Versus Pioglitazone on Albuminuria in Patients with Type 2 Diabetes Mellitus. Diabetes Ther. 2021 Jan;12(1):171-181. doi: 10.1007/s13300-020-00948-1. Epub 2020 Oct 24.
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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.
SungWoo Park, M.D., Ph.D. study chair
Kangbuk Samsung 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 CKD-501 0.5mg and Pioglitazone 15mg in people with Type 2 Diabetes Mellitus, 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 6 inclusion and 24 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 15 Feb 2013. 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 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 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?
On the ClinicalTrials.gov record for NCT01106131, which also lists 1 linked publication.
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 15 Feb 2013.