Type 2 DiabetesPhase 4NCT02285205
A 24 Week, Multicenter, Prospective, Open-labeled, Single-arm, Exploratory Phase 4 Clinical Trial to Evaluate the Safety and Efficacy of Lobeglitazone in Decreasing Intrahepatic Fat Contents in Type 2 Diabetes With NAFLD
A Phase 4 study testing Oral administration of Lobeglitazone in people with Type 2 Diabetes and Non-alcoholic Fatty Liver Disease, run by Yonsei University at 1 site in South Korea.
Trial summary
Lobeglitazone is highly selective peroxisome proliferator-activated receptor-gamma agonist that decreases insulin resistance in the periphery and liver resulting in increased insulin-dependent glucose disposal and decreased hepatic glucose output. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Type 2 Diabetes, Non-alcoholic Fatty Liver Disease
- What is being tested?
- Oral administration of Lobeglitazone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2014to Nov 2015
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type Ⅱ diabetes mellitus
- Non-alcoholic fatty liver disease: subjects who have CAP(Controlled Attenuation Parameter) ≥ 250dB/m measured by transient elastography (fibroscan) at screening test
- Age ≥ 20 years
- Patients who have not been taking any oral hypoglycemic agent for more than 12 weeks with HbA1c 7.0 to 8.5% at screening test or who have been taking metformin monotherapy for at least 8 weeks with HbA1c 7 to 9% at screening test
- Agreement with written informed consent
Who cannot join
- Patients whose alcohol consumption >210g/week for males and 140g/week for females
- chronic B viral hepatitis, chronic C viral hepatitis, Type I diabetes, or secondary diabetes
- having a history of acute or chronic metabolic acidosis including diabetic ketoacidosis
- patients who have been taking other oral hypoglycemic agents except metformin or insulin within recent 8 weeks
- who experienced hypersensitivity reaction against metformin or glitazone drugs
- who has been treated with corticosteroids for at least 14 days within 2 month prior to Screening
Show all 19Show fewer
- having a history of lactic acidosis
- having genetic predispositions such as galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
- who are in condition of malnutrition, starvation, cachexia, severe infection, major trauma, hypopituitarism, or adrenal insufficiency
- diagnosed with cancer within 2 years or having chemo or radiotherapy for cancer treatment
- a history of drug abuse or chronic alcoholism
- a history of heart failure (NYHA class III and IV) or uncontrolled arrhythmia
- a history of acute cardiovascular or cerebrovascular disease within 12 weeks prior to Screening (unstable angina, myocardial infarction, transient ischemic attack, cerebral infarct, cerebral hemorrhage, coronary bypass, percutaneous coronary intervention)
- Renal dysfunction: Serum creatinine greater than 1.5mg/dl for males and 1.4mg/dl for females.
- Anemia less than 10.5g/dl for any reason
- Pregnant women or nursing mothers
- Fertile women who not practice contraception with appropriate methods
- in treatment concomitant drug from other clinical trials within 4 weeks from enrollment
- who did not agree with written informed consent
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Severance Hospital, Department of Internal Medicine, Yonsei University College of Medicine
Seoul, Seoul, 120-752
About this study
Lobeglitazone is highly selective peroxisome proliferator-activated receptor-gamma agonist that decreases insulin resistance in the periphery and liver resulting in increased insulin-dependent glucose disposal and decreased hepatic glucose output. In vivo, It demonstrates that Lobeglitazone improves even more glycemic and lipid control in comparison to rosiglitazone and pioglitazone. Currently, thiazolidinediones such as pioglitazone is the only drug which is considered as an effective therapeutic agent for improving non-alcoholic fatty liver disease (NALFD) in type 2 diabetes (T2D).
The aim of this multicenter, prospective, open-labeled, single-arm, exploratory phase 4 study is to evaluate the efficacy and safety of Lobeglitazone once daily for 24 weeks on intrahepatic fat contents assessed by transient elastography (fibroscan) in T2D with NAFLD.
Read more
Fifty subjects with T2D and NAFLD will take Lobeglitazone (0.5mg/tablet, orally, 1 tablet once daily) for 24 weeks.
Primary endpoint is changes from baseline in controlled attenuation parameters (CAP) measured by transient elastography (fibroscan) after treatment with Lobeglitazone.
Secondary endpoints are changes from baseline in glycemic profiles (HbA1c, Glycated albumin), Lipid parameters (Total Cholesterol, Triglycerides, HDL-C, LDL-C), Liver function parameters (AST, ALT, r-GT), and adverse events during the trial.
- Conditions
- Type 2 Diabetes, Non-alcoholic Fatty Liver Disease
- Being tested
- Oral administration of Lobeglitazone
- Medical subject headings
- Diabetes Mellitus, Type 2, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral administration of LobeglitazoneDrug
Lobeglitazone 0.5mg/tablet, orally, 1 tablet once daily for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Lobeglitazone | Experimental | Not described Receives: Drug: Oral administration of Lobeglitazone |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes from baseline in controlled attenuation parameters (CAP)
Changes from baseline in controlled attenuation parameters (CAP) measured by transient elastography (fibroscan) after treatment with Lobeglitazone
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionNov 2015
- Study completionNov 2015
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 DiabetesStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02285205
- Sponsor's protocol ID
- 4-2014-0778
- Status last verified
- Jan 2016
- First submitted
- 4 Nov 2014
- Last updated
- 2 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Lee YH, Kim JH, Kim SR, Jin HY, Rhee EJ, Cho YM, Lee BW. Lobeglitazone, a Novel Thiazolidinedione, Improves Non-Alcoholic Fatty Liver Disease in Type 2 Diabetes: Its Efficacy and Predictive Factors Related to Responsiveness. J Korean Med Sci. 2017 Jan;32(1):60-69. doi: 10.3346/jkms.2017.32.1.60.
PubMed 27914133
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 24 Week, Multicenter, Prospective, Open-labeled, Single-arm, Exploratory Phase 4 Clinical Trial to Evaluate the Safety and Efficacy of Lobeglitazone in Decreasing Intrahepatic Fat Contents in Type 2 Diabetes With NAFLD
- ClinicalTrials.gov ID
- NCT02285205
- Acronym / sponsor ID
- 4-2014-0778
- Conditions
- Type 2 Diabetes, Non-alcoholic Fatty Liver Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 6 Nov 2014 (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.
Lobeglitazone is highly selective peroxisome proliferator-activated receptor-gamma agonist that decreases insulin resistance in the periphery and liver resulting in increased insulin-dependent glucose disposal and decreased hepatic glucose output. In vivo, It demonstrates that Lobeglitazone improves even more glycemic and lipid control in comparison to rosiglitazone and pioglitazone. Currently, thiazolidinediones such as pioglitazone is the only drug which is considered as an effective therapeutic agent for improving non-alcoholic fatty liver disease (NALFD) in type 2 diabetes (T2D).
The aim of this multicenter, prospective, open-labeled, single-arm, exploratory phase 4 study is to evaluate the efficacy and safety of Lobeglitazone once daily for 24 weeks on intrahepatic fat contents assessed by transient elastography (fibroscan) in T2D with NAFLD.
Fifty subjects with T2D and NAFLD will take Lobeglitazone (0.5mg/tablet, orally, 1 tablet once daily) for 24 weeks.
Primary endpoint is changes from baseline in controlled attenuation parameters (CAP) measured by transient elastography (fibroscan) after treatment with Lobeglitazone.
Secondary endpoints are changes from baseline in glycemic profiles (HbA1c, Glycated albumin), Lipid parameters (Total Cholesterol, Triglycerides, HDL-C, LDL-C), Liver function parameters (AST, ALT, r-GT), and adverse events during the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lobeglitazone | Experimental | Drug: Oral administration of Lobeglitazone |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Type Ⅱ diabetes mellitus
- Non-alcoholic fatty liver disease: subjects who have CAP(Controlled Attenuation Parameter) ≥ 250dB/m measured by transient elastography (fibroscan) at screening test
- Age ≥ 20 years
- Patients who have not been taking any oral hypoglycemic agent for more than 12 weeks with HbA1c 7.0 to 8.5% at screening test or who have been taking metformin monotherapy for at least 8 weeks with HbA1c 7 to 9% at screening test
- Agreement with written informed consent
Key exclusion criteria (19 listed)
- Patients whose alcohol consumption >210g/week for males and 140g/week for females
- chronic B viral hepatitis, chronic C viral hepatitis, Type I diabetes, or secondary diabetes
- having a history of acute or chronic metabolic acidosis including diabetic ketoacidosis
- patients who have been taking other oral hypoglycemic agents except metformin or insulin within recent 8 weeks
- who experienced hypersensitivity reaction against metformin or glitazone drugs
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 |
|---|---|---|
| Oral administration of LobeglitazoneLobeglitazone 0.5mg/tablet, orally, 1 tablet once daily for 24 weeks | Drug | Lobeglitazone |
Primary outcome
changes from baseline in controlled attenuation parameters (CAP)
Time frame: 24 weeks
Changes from baseline in controlled attenuation parameters (CAP) measured by transient elastography (fibroscan) after treatment with Lobeglitazone
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 2 Feb 2016.
- Derived from this study: PubMed 27914133Lee YH, Kim JH, Kim SR, Jin HY, Rhee EJ, Cho YM, Lee BW. Lobeglitazone, a Novel Thiazolidinedione, Improves Non-Alcoholic Fatty Liver Disease in Type 2 Diabetes: Its Efficacy and Predictive Factors Related to Responsiveness. J Korean Med Sci. 2017 Jan;32(1):60-69. doi: 10.3346/jkms.2017.32.1.60.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Oral administration of Lobeglitazone in people with Type 2 Diabetes and Non-alcoholic Fatty Liver Disease, run by Yonsei University 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 5 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 2 Feb 2016. 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?
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?
changes from baseline in controlled attenuation parameters (CAP) (time frame: 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 NCT02285205, 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 2 Feb 2016.