Type 2 DiabetesPhase 3NCT02827903
Metformin/Rosuvastatin Combination Therapy With in Patients With Type 2 Diabetes and Dyslipidemia
A Phase 3 study testing Metformin + Rosuvastatin in people with Type 2 Diabetes and Dyslipidemia, run by Jeil Pharmaceutical Co., Ltd. at 33 sites in South Korea.
Trial summary
Compare the Efficacy and Safety of Metformin/Rosuvastatin Combination Therapy With Metformin or Rosuvastatin Monotherapy in Patients With Type 2 Diabetes and Dyslipidemia Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Type 2 Diabetes, Dyslipidemia
- What is being tested?
- Metformin + Rosuvastatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 237 participants
- Where
- 33 sitesSouth Korea
- Study dates
- 15 Jan 2016to 16 Mar 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 19 years
- Type II DM with Dyslipidemia
- 6.5% ≤ HbA1c < 11%
- Triglyceride < 350mg/dL
- 100mg/dL ≤ LDL-C ≤ 250mg/dL
- FPG ≤ 270mg/dL
Who cannot join
- Type I DM
- Unstable angina, MI, Stroke, CABG with 6 month from screening
- SBP ≥ 180mmHg, DBP ≥ 110mmHg
- TSH > UNL
- Heart failure (NYHA class III/IV)
- Serum Creatinine > UNL or CLCr < 60 mL/min
Show all 9Show fewer
- CK ≥ 2x UNL
- HIV positive
- BMI > 40 kg/m^2
Trial locations and contacts
33 sites in 1 country.
33 sites in 1 country
South Korea33 sites
Buchoen St. mary's Hospital
Bucheon-si
SeJong Hostpital
Bucheon-si
SoonChunHyang University Bucheon Hospital
Bucheon-si
InJe University Busan paik Hospital
Busan
Inje University Haeundae paik hospital
Busan
Daegu Catholic University Medical Center
Daegu
Youngnam University Hostpital
Daegu
Daeheon Eulji Medical Center
Daejeon
KonYang University Hostpital
Daejeon
Chosun University Hospital
Gwangju
BunDang Jesang Hospital(DMC)
Gyeonggi-do
Hallym University Sacred Heart hospital
Gyeonggi-do
HanYang University Guri Hospital
Gyeonggi-do
Inje University Ilsan paik hospital
Gyeonggi-do
Myoung Ji Hospital
Gyeonggi-do
Gachon Gil Hospital
Incheon
Inchoen St. mary's Hospital
Incheon
Eulji Hospital Nowon
Seoul
Hallym University Kangnam Sacred Heart hospital
Seoul
KangBuk SamSung Hospital
Seoul
Kangdong Sacred Heart Hospital
Seoul
KonKuk University Medical Center
Seoul
Korea University Anam Hospital
Seoul
KyungHee University Hospital at Gangdong
Seoul
Samsung Medical Center
Seoul
Seoul National University Hospital(Famlily medicine)
Seoul
Seoul National University Hospital
Seoul
Severance hospital
Seoul
SoonChunHayng University Hospital Seoul
Seoul
The catholic University of Korea YEOUIDO St mary's Hospital
Seoul
Korea University Guro hospital
Soeul
Ajou University hospital
Suwon
Wonju Severance Christian hospital
Wŏnju
About this study
Official title: A Multi-center, Randomized, Double-blind, Phase III Clinical Trial to Compare the Efficacy and Safety of Metformin/Rosuvastatin Combination Therapy With Metformin or Rosuvastatin Monotherapy in Patients With Type 2 Diabetes and Dyslipidemia
Compare the Efficacy and Safety of Metformin/Rosuvastatin Combination Therapy With Metformin or Rosuvastatin Monotherapy in Patients With Type 2 Diabetes and Dyslipidemia
Read the detailed description
Multi-center, Randomized, Double-blind, Phase III clinical trial
- Conditions
- Type 2 Diabetes, Dyslipidemia
- Being tested
- Metformin + Rosuvastatin, Metformin + placebo, placebo + Rosuvastatin
- Keywords
- Metformin, Rosuvastatin, type 2 diabetes, dyslipidemia
- Medical subject headings
- Diabetes Mellitus, Type 2, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metformin + RosuvastatinDrug
Group I: Metformin + Rosuvastatin,
Metformin + placeboDrug
Group II: Metformin + placebo,
placebo + RosuvastatinDrug
Group III: placebo + Rosuvastatin
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | Metformin + Rosuvastatin, Dosing to Type II DM with Dyslipidemia Receives: Drug: Metformin + Rosuvastatin |
| Group II | Active comparator | Metformin + placebo, Dosing to Type II DM with Dyslipidemia Receives: Drug: Metformin + placebo |
| Group III | Active comparator | Placebo + Rosuvastatin, Dosing to Type II DM with Dyslipidemia Receives: Drug: placebo + Rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL-C (% change)
Measured: 16 weeks from baseline
change of HbA1c
Measured: 16 weeks from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study start15 Jan 2016
- Primary completion21 Nov 2017
- Study completion16 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 237 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jeil Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02827903
- Sponsor's protocol ID
- JLP-1310-P3-15
- Status last verified
- Mar 2018
- First submitted
- 23 Jun 2016
- Last updated
- 6 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind, Phase III Clinical Trial to Compare the Efficacy and Safety of Metformin/Rosuvastatin Combination Therapy With Metformin or Rosuvastatin Monotherapy in Patients With Type 2 Diabetes and Dyslipidemia
- ClinicalTrials.gov ID
- NCT02827903
- Acronym / sponsor ID
- JLP-1310-P3-15
- Conditions
- Type 2 Diabetes, Dyslipidemia
- Keywords
- Metformin, Rosuvastatin, type 2 diabetes, dyslipidemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 237 participants (actual)
- Lead sponsor
- Jeil Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Jan 2016 (actual)
- Primary completion
- 21 Nov 2017 (actual)
- Study completion
- 16 Mar 2018 (actual)
- First posted
- 11 Jul 2016 (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.
Compare the Efficacy and Safety of Metformin/Rosuvastatin Combination Therapy With Metformin or Rosuvastatin Monotherapy in Patients With Type 2 Diabetes and Dyslipidemia
Detailed description
Multi-center, Randomized, Double-blind, Phase III clinical trial
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Drug: Metformin + RosuvastatinMetformin + Rosuvastatin, Dosing to Type II DM with Dyslipidemia |
| Group II | Active comparator | Drug: Metformin + placeboMetformin + placebo, Dosing to Type II DM with Dyslipidemia |
| Group III | Active comparator | Drug: placebo + RosuvastatinPlacebo + Rosuvastatin, Dosing to Type II DM with Dyslipidemia |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Over 19 years
- Type II DM with Dyslipidemia
- 6.5% ≤ HbA1c < 11%
- Triglyceride < 350mg/dL
- 100mg/dL ≤ LDL-C ≤ 250mg/dL
Key exclusion criteria (9 listed)
- Type I DM
- Unstable angina, MI, Stroke, CABG with 6 month from screening
- SBP ≥ 180mmHg, DBP ≥ 110mmHg
- TSH > UNL
- Heart failure (NYHA class III/IV)
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 |
|---|---|---|
| Metformin + RosuvastatinGroup I: Metformin + Rosuvastatin, | Drug | Group I |
| Metformin + placeboGroup II: Metformin + placebo, | Drug | Group II |
| placebo + RosuvastatinGroup III: placebo + Rosuvastatin | Drug | Group III |
Primary outcome
LDL-C (% change)
Time frame: 16 weeks from baseline
change of HbA1c
Time frame: 16 weeks from baseline
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 6 Jul 2018.
- 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.
33 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Metformin + Rosuvastatin in people with Type 2 Diabetes and Dyslipidemia, run by Jeil Pharmaceutical Co., Ltd. at 33 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 9 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 6 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 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. 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?
LDL-C (% change) (time frame: 16 weeks from baseline). The study lists 2 primary outcomes in all. 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 6 Jul 2018.