Diabetes Mellitus, Type 2Phase 2NCT01030679
Evaluate the Glycemic Control of CKD-501 in Type 2 Diabetes Mellitus
A Phase 2 study testing CKD-501 0.5mg, CKD-501 1mg and CKD-501 2mg in people with Diabetes Mellitus, Type 2, run by Chong Kun Dang Pharmaceutical at 8 sites in South Korea.
Trial summary
The purpose of this study is to assess the safety and effectiveness of three doses of CKD-501 compared to placebo in lowering fasting plasma glucose levels in people with type 2 diabetes for 8 weeks. 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?
- CKD-501 0.5mg, CKD-501 1mg and CKD-501 2mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 214 participants
- Where
- 8 sitesSouth Korea
- Study dates
- Jul 2007to Oct 2008
- Phase
- Phase 2
- 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
- Type Ⅱ diabetes mellitus
- Fasting Plasma Glucose(FPG)≥ 126 and ≤ 270
- HbA1c between 7 and 11%
- Body mass index (BMI) in the range 21-40
- The patients who has been taking oral hypoglycemic agent or diet therapy before minimum 1 month
- Agreement with written informed consent
Who cannot join
- Type I diabetes, gestational diabetes or secondary diabetes
- Treatment with insulin(over 1month) within 3 months
- Fasting Plasma Glucose level is over 270 mg/dl
- Triglyceride level is 500 mg/dl and over
- Uncontrollable hypertension
- History of myocardial infarction, heart failure, cerebral infarction, hematencephalon or unstable angina within 6 months
Show all 19Show fewer
- Severe hepatic dysfunction: AST, ALT, Total bilirubin, ALP level over or equal to 3 times as high as upper normal limit(UNL)
- Severe renal dysfunction: Renal failure or serum creatinine greater than 30% normal limit
- Needs treatment for acute disease, uncontrolled other diseae or diabetic complications
- In treatment concomitant drug having severe risk drug interaction with investigational drug
- History of cancer within 5 years
- History of drug abuse or alcoholism
- Hepatitis B Antigen(HBsAg) test is positive
- Treatment systemic or inhalant corticosteroids within 1 month prior to Screening
- Patient who have experience such as hypersensitivity reaction, serious adverse event or no effect by treatment with glitazones
- Fertile women who not practice contraception with appropriate methods Pregnant women or nursing mothers
- Has a contraindication to treatment investigational drug from the medical and psychogenic side
- Participated in other trial within 4 weeks Participating in other trial at present
- An impossible one who participates in clinical trial by legal or investigator's decision
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
South Korea8 sites
The Inje University Medical Center
Busan
The Yeungnam University Hospital
Daegu
The Chtholic University of Korea Uijeongbu St. Mary's Hospital
Gyeonggi-do
The Seoul National Univertisy Bundang Hospital
Gyeonggi-do
The Wonju Christian Hospital
Kangwon-Do
The Inje University Sanggye-Paik Hospital
Seoul
The Korea University Anam Hospital
Seoul
The Samsung Medical Center
Seoul
About this study
Official title: To Investigate the Glycemic Control and Lipid Profile of CKD-501 Monotherapy in Patients With Type 2 Diabetes Mellitus:a Eight-week, Multicenter, Randomized, Double-blind, Parallel-Group, Placebo-controlled, Dose-ranging Study.
The purpose of this study is to assess the safety and effectiveness of three doses of CKD-501 compared to placebo in lowering fasting plasma glucose levels in people with type 2 diabetes for 8 weeks.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- CKD-501 0.5mg, CKD-501 1mg, CKD-501 2mg, Placebo
- Keywords
- Diabetes Mellitus, type 2, Glitazone
- 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
0.5 mg/tablet, orally, 1 tablet once daily for 8 weeks
CKD-501 1mgDrug
Also called Lobeglitazone
1 mg/tablet, orally, 1 tablet once daily for 8 weeks
CKD-501 2mgDrug
Also called Lobeglitazone
2 mg/tablet, orally, 1 tablet once daily for 8 weeks
PlaceboDrug
orally, 1 tablet once daily for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| CKD-501 0.5mg | Experimental | Not described Receives: Drug: CKD-501 0.5mg |
| CKD-501 1mg | Experimental | Not described Receives: Drug: CKD-501 1mg |
| CKD-501 2mg | Experimental | Not described Receives: Drug: CKD-501 2mg |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in fasting plasma glucose at 8 weeks
Measured: 8 weeks
Secondary outcomes (3)
Change from baseline in Glycemic parameters after 8 weeks
Measured: 8 weeks
Change from baseline in Lipid parameters after 8 weeks
Measured: 8 weeks
Adverse event profile after 8 weeks of treatment
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2009 (estimated)
- Study startJul 2007
- Primary completionOct 2008
- Study completionOct 2008
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Dongseop Choi, MD.,Ph.D., Study chair, The Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01030679
- Sponsor's protocol ID
- 19DM05L
- Status last verified
- Dec 2009
- First submitted
- 9 Dec 2009
- Last updated
- 16 Dec 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Investigate the Glycemic Control and Lipid Profile of CKD-501 Monotherapy in Patients With Type 2 Diabetes Mellitus:a Eight-week, Multicenter, Randomized, Double-blind, Parallel-Group, Placebo-controlled, Dose-ranging Study.
- ClinicalTrials.gov ID
- NCT01030679
- Acronym / sponsor ID
- 19DM05L
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes Mellitus, type 2, Glitazone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 11 Dec 2009 (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 assess the safety and effectiveness of three doses of CKD-501 compared to placebo in lowering fasting plasma glucose levels in people with type 2 diabetes for 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CKD-501 0.5mg | Experimental | Drug: CKD-501 0.5mg |
| CKD-501 1mg | Experimental | Drug: CKD-501 1mg |
| CKD-501 2mg | Experimental | Drug: CKD-501 2mg |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Type Ⅱ diabetes mellitus
- Fasting Plasma Glucose(FPG)≥ 126 and ≤ 270
- HbA1c between 7 and 11%
- Body mass index (BMI) in the range 21-40
- The patients who has been taking oral hypoglycemic agent or diet therapy before minimum 1 month
Key exclusion criteria (19 listed)
- Type I diabetes, gestational diabetes or secondary diabetes
- Treatment with insulin(over 1month) within 3 months
- Fasting Plasma Glucose level is over 270 mg/dl
- Triglyceride level is 500 mg/dl and over
- Uncontrollable hypertension
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: Lobeglitazone0.5 mg/tablet, orally, 1 tablet once daily for 8 weeks | Drug | CKD-501 0.5mg |
| CKD-501 1mgAlso: Lobeglitazone1 mg/tablet, orally, 1 tablet once daily for 8 weeks | Drug | CKD-501 1mg |
| CKD-501 2mgAlso: Lobeglitazone2 mg/tablet, orally, 1 tablet once daily for 8 weeks | Drug | CKD-501 2mg |
| Placeboorally, 1 tablet once daily for 8 weeks | Drug | Placebo |
Primary outcome
Change from baseline in fasting plasma glucose at 8 weeks
Time frame: 8 weeks
3 secondary outcomes
Change from baseline in Glycemic parameters after 8 weeks
Time frame: 8 weeks
Change from baseline in Lipid parameters after 8 weeks
Time frame: 8 weeks
Adverse event profile after 8 weeks of treatment
Time frame: 8 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 16 Dec 2009.
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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.
Dongseop Choi, MD.,Ph.D. study chair
The Korea University Anam Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CKD-501 0.5mg, CKD-501 1mg and CKD-501 2mg in people with Diabetes Mellitus, Type 2, run by Chong Kun Dang Pharmaceutical at 8 sites 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 19 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 16 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 fasting plasma glucose at 8 weeks (time frame: 8 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 16 Dec 2009.