Type 2 Diabetes MellitusPhase 4NCT03770052
Glucose-Lowering Effects and Safety of Adding 0.25 or 0.5 mg Duvie
A Phase 4 study testing duvie in people with Type 2 Diabetes Mellitus and Inadequate Glucose Control, run by Pusan National University Hospital at 1 site in South Korea.
Trial summary
Glucose-Lowering Effects and Safety of Adding 0.25 or 0.5 mg Duvie Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Inadequate Glucose Control
- What is being tested?
- duvie
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Oct 2018to 13 Sep 2021
- 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type Ⅱ diabetes mellitus
- Between 19 years and 80 years old
- BMI between 20kg/㎡ to 45kg/㎡
- Among those using Metformin and DPP-4 inhibitor merging therapy for more than 3 months, A person who has not changed the dosage of Metformin 500 mg and DPP-4 inhibitor for more than 8 weeks at the time of screening
- HbA1c 7.0 to 9.0
- Agreement with written informed consent
Who cannot join
- Historical history of severe heart failure or heart failure (NYHA Class III\&IV)
- Rapid coronary syndrome, cardiovascular interventions within 6 months
- History of cerebral vascular diseases within six months
- High blood pressure uncontrolled (>160/100 mmHg)
- In case weight loss drug is used within 3 months
- In case of systemic corticosteroids treatment within 3 months
Show all 27Show fewer
- If there is an allergy or overreaction to the study drug or its components
- In case of acute metabolic complications (ketonicemia or high osmotic pressure) within 6 months
- Anemia Hb < 12g/dL(male), 10g/dL(female)
- Kidney function GFR < 45mL/min/1.73m2 (GFR test results are calculated by the Cockcroft-Gault Calculator).
- impaired hepatic function (AST/ALT 2.5-fold the upper limit of the normal range [ULN])
- TG>500 mg/dL
- LDL cholesterol >160 mg/dL
- If a lipid-lowering agent is being taken, the existing dose should be taken during the study period.
- The thyroid hormone is within its normal range
- however, thyroid hormone may be registered at the discretion of the investigator even if it is outside the normal range.
- Laser treatment for proliferative retinopathy within 6 months
- history of alcohol or drug abuse in the previous 3 months
- history of most cancers not in remission for 5 years
- Past history of bladder cancer
- Women nursing or pregnant Persons who are not using effective contraceptive methods, or who refuse to use contraceptives as specified below (permitted contraceptives: condoms, castings, or implantation contraceptives, etc.) are installed with contraceptives in the uterus
- external injury, acute infections, a history/presence of any other severe disease, or severe trauma
- Patients who use basins - however, they can be registered by stopping 8 weeks before the start of administration of medicines for clinical trials
- A person who has used endemic insulin for more than 7 days in the last 8 weeks
- A person with the drug usage in the TZD series over the last eight weeks.
- When experiencing allergies, hypersensitivity, or side effects associated with drug use in the TZD series;
- The researcher determines that other participants may experience difficulties in participating in the test through to the end, or that participation in the test may result in additional risks or confusion in the test results.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double Blind, Randomized, Investigator Initiated Study on Glucose-Lowering Effects and Safety of Adding 0.25 or 0.5 mg Duvie (Lobeglitazone) in Patients With Type 2 Diabetes With Inadequate Control on Metformin and DPP-4 Inhibitor Therapy
Glucose-Lowering Effects and Safety of Adding 0.25 or 0.5 mg Duvie
Read the detailed description
This study is a double blind, randomized, investigator initiated study on glucose-lowering effects and Safety of Adding 0.25 or 0.5 mg Duvie (Lobeglitazone) in Patients With Type 2 Diabetes With Inadequate Control on Metformin and DPP-4 Inhibitor Therapy. The primary aim of the study is to compared changes of HbA1c between 0.25mg robeblitazone add-on group and 0.5mg robeglitazone add-on group.
- Being tested
- duvie
- 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.
duvieDrug
take the intervention drug once daily according to the randomized groups
| Study group | Role | What they receive |
|---|---|---|
| 0.25mg robeglitazone add-on group | Experimental | 0.25mg robeglitazone once daily in patients with type 2 diabetes with inadequate control on metformin and DPP-4 inhibitor therapy Receives: Drug: duvie |
| 0.5mg robeglitazone add-on group | Active comparator | 0.5mg robeglitazone once daily in patients with type 2 diabetes with inadequate control on metformin and DPP-4 inhibitor therapy Receives: Drug: duvie |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c at 24 week
changes of HbA1c between baseline and 24 week
Measured: 24 week
Secondary outcomes (9)
HOMA-IR
changes of HOMA-IR between baseline and 24 week
Measured: 24 week
lipid levels
changes of lipid levels between baseline and 24 week
Measured: 24 week
hs-CRP
changes of hs-CRP between baseline and 24 week
Measured: 24 week
AST
changes of AST between baseline and 24 week
Measured: 24 week
adiponectin
changes of adiponectin between baseline and 24 week
Measured: 24 week
adverse event (weight gain,edema)
changes of adverse event (weight gain,edema) between baseline and 24 week
Measured: 24 week
ALT
changes of ALT between baseline and 24 week
Measured: 24 week
ALP
changes of ALP between baseline and 24 week
Measured: 24 week
total bilirubin
changes of total bilirubin between baseline and 24 week
Measured: 24 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2018
- Study start24 Oct 2018
- Primary completion19 Aug 2021
- Study completion13 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pusan National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chong Kun Dang Pharmaceutical Corp.
- Responsible party
- Principal investigator, In Ju Kim, Pusan National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03770052
- Sponsor's protocol ID
- Duvie2.5
- Status last verified
- Jan 2022
- First submitted
- 6 Dec 2018
- Last updated
- 20 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 20 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Randomized, Investigator Initiated Study on Glucose-Lowering Effects and Safety of Adding 0.25 or 0.5 mg Duvie (Lobeglitazone) in Patients With Type 2 Diabetes With Inadequate Control on Metformin and DPP-4 Inhibitor Therapy
- ClinicalTrials.gov ID
- NCT03770052
- Acronym / sponsor ID
- Duvie2.5
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Pusan National University HospitalUniversity, hospital or other
- Collaborators
- Chong Kun Dang Pharmaceutical Corp.
- Study start
- 24 Oct 2018 (actual)
- Primary completion
- 19 Aug 2021 (actual)
- Study completion
- 13 Sep 2021 (actual)
- First posted
- 10 Dec 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.
Glucose-Lowering Effects and Safety of Adding 0.25 or 0.5 mg Duvie
Detailed description
This study is a double blind, randomized, investigator initiated study on glucose-lowering effects and Safety of Adding 0.25 or 0.5 mg Duvie (Lobeglitazone) in Patients With Type 2 Diabetes With Inadequate Control on Metformin and DPP-4 Inhibitor Therapy. The primary aim of the study is to compared changes of HbA1c between 0.25mg robeblitazone add-on group and 0.5mg robeglitazone add-on group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0.25mg robeglitazone add-on group | Experimental | Drug: duvie0.25mg robeglitazone once daily in patients with type 2 diabetes with inadequate control on metformin and DPP-4 inhibitor therapy |
| 0.5mg robeglitazone add-on group | Active comparator | Drug: duvie0.5mg robeglitazone once daily in patients with type 2 diabetes with inadequate control on metformin and DPP-4 inhibitor therapy |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Type Ⅱ diabetes mellitus
- Between 19 years and 80 years old
- BMI between 20kg/㎡ to 45kg/㎡
- Among those using Metformin and DPP-4 inhibitor merging therapy for more than 3 months, A person who has not changed the dosage of Metformin 500 mg and DPP-4 inhibitor for more than 8 weeks at the time of screening
- HbA1c 7.0 to 9.0
Key exclusion criteria (27 listed)
- Historical history of severe heart failure or heart failure (NYHA Class III\&IV)
- Rapid coronary syndrome, cardiovascular interventions within 6 months
- History of cerebral vascular diseases within six months
- High blood pressure uncontrolled (>160/100 mmHg)
- In case weight loss drug is used 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 |
|---|---|---|
| duvietake the intervention drug once daily according to the randomized groups | Drug | 0.25mg robeglitazone add-on group, 0.5mg robeglitazone add-on group |
Primary outcome
HbA1c at 24 week
Time frame: 24 week
changes of HbA1c between baseline and 24 week
9 secondary outcomes
HOMA-IR
Time frame: 24 week
lipid levels
Time frame: 24 week
hs-CRP
Time frame: 24 week
AST
Time frame: 24 week
adiponectin
Time frame: 24 week
adverse event (weight gain,edema)
Time frame: 24 week
ALT
Time frame: 24 week
ALP
Time frame: 24 week
total bilirubin
Time frame: 24 week
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 20 Jan 2022.
- 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.
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 duvie in people with Type 2 Diabetes Mellitus and Inadequate Glucose Control, run by Pusan National University Hospital 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 27 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 20 Jan 2022. 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?
HbA1c at 24 week (time frame: 24 week). 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 20 Jan 2022.