Type II DiabetesPhase 3NCT02947620
Metformin/Atorvastatin Combination Therapy in Subjects With Type II Diabetes and Dyslipidemia (Phase 3)
A Phase 3 study testing Metformin/Atorvastatin 1500mg/40mg, QD, Metformin 1500mg, QD and Atorvastatin 40mg, QD in people with Type II Diabetes and Dyslipidemia, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial summary
A Multi-center, Randomized, double-blind, active-controlled, phase 3 trial to evaluate the safety and efficacy of Metformin/Atorvastatin in subjects with Type II Diabetes and dyslipidemia. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Type II Diabetes, Dyslipidemia
- What is being tested?
- Metformin/Atorvastatin 1500mg/40mg, QD, Metformin 1500mg, QD and Atorvastatin 40mg, QD
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 185 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2015to 27 Feb 2017
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with Dyslipidemia and Type II Diabetes
- 19 years later, men and women under the age of 80
Who cannot join
- Pregnant women, nursing mothers or subject who does not agree to assigned contraception in the study
- Subject with type I Diabetes
- Subject with hypertension which does not controlled by treatment(have blood pressure > 180/110mmHg)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-center, Randomized, Double-blind, Active-controlled, Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of Metformin/Atorvastatin Combination Therapy in Subjects With Type II Diabetes and Dyslipidemia
A Multi-center, Randomized, double-blind, active-controlled, phase 3 trial to evaluate the safety and efficacy of Metformin/Atorvastatin in subjects with Type II Diabetes and dyslipidemia.
- Conditions
- Type II Diabetes, Dyslipidemia
- Being tested
- Metformin/Atorvastatin 1500mg/40mg, QD, Metformin 1500mg, QD, Atorvastatin 40mg, QD
- 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/Atorvastatin 1500mg/40mg, QDDrug
Metformin 1500mg, QDDrug
Atorvastatin 40mg, QDDrug
| Study group | Role | What they receive |
|---|---|---|
| Metformin/Atorvastatin | Active comparator | Metformin/Atorvastatin, QD Receives: Drug: Metformin/Atorvastatin 1500mg/40mg, QD |
| Metformin | Placebo comparator | Metformin, QD Receives: Drug: Atorvastatin 40mg, QD |
| Atorvastatin | Placebo comparator | Atorvastatin, QD Receives: Drug: Metformin 1500mg, QD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c
Change in HbA1c after 16 weeks, relative to baseline, between the combination of Metformin 1500 mg and Atorvastatin 40 mg compared to Atorvastatin 40 mg alone
Measured: Change from baseline at 16 weeks
Change in LDL Cholesterol
Change in low-density lipoprotein cholesterol (LDL-C) after 16 weeks, relative to baseline, between Metformin 1500 mg alone and the combination of Metformin 1500 mg and Atorvastatin 40 mg
Measured: Change from baseline at 16 weeks
Secondary outcomes (9)
Change in LDL-C
Change in LDL-C after 16 weeks, relative to baseline, between Atorvastatin 40 mg and the combination of Metformin 1500 mg and Atorvastatin 40 mg
Measured: Baseline and 16 weeks
Change in HbA1c
Change in HbA1c after 16 weeks, relative to baseline, between Metformin 1500 mg alone and the combination of Metformin 1500 mg and Atorvastatin 40 mg
Measured: Baseline and 16 weeks
Percentage of subjects reaching the LDL-C treatment goal defined by the NCEP ATP III guideline (<100mg/dL) after 16 weeks of treatment with investigational products
Measured: 16 weeks
Percentage of subjects reaching HbA1c <7.0% and <6.5% after 16 weeks of treatment with investigational products
Measured: 16 weeks
Change in LDL-C and the associated rate of change after 4, 8, and 12 weeks of treatment with investigational products compared to baseline
Measured: Baseline, 4 weeks, 8 weeks and 12 weeks
Change in LDL-C after 16 weeks, relative to baseline, in subjects treated with investigational products
Measured: Baseline and 16 weeks
Change in lipid variables and the associated rate of change
Change in lipid variables (HDL-C, TG, TC, non-HDL cholesterol, Apolipoprotein A1, Apolipoprotein B) and the associated rate of change after 4, 8, 12, and 16 weeks of treatment with investigational products compared to baseline
Measured: Baseline, 4 weeks, 8 weeks and 12 weeks and 16 weeks
Change in average fasting plasma glucose (FPG) after 4, 8, 12, and 16 weeks of treatment with investigational products compared to baseline
Measured: Baseline, 4 weeks, 8 weeks and 12 weeks and 16 weeks
Change in Insulin, HOMA-β, HOMA-IR after 4, 8, 12, and 16 weeks of treatment with investigational products compared to baseline.
Measured: Baseline, 4 weeks, 8 weeks and 12 weeks and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2016 (estimated)
- Study startAug 2015
- Primary completion27 Feb 2017
- Study completion27 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type II DiabetesStudies of the same condition, open and under way.
- More trials run by Daewoong Pharmaceutical Co. LTD.The 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02947620
- Sponsor's protocol ID
- DW_MA001
- Status last verified
- Oct 2016
- First submitted
- 26 Oct 2016
- Last updated
- 18 Jun 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind, Active-controlled, Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of Metformin/Atorvastatin Combination Therapy in Subjects With Type II Diabetes and Dyslipidemia
- ClinicalTrials.gov ID
- NCT02947620
- Acronym / sponsor ID
- DW_MA001
- Conditions
- Type II Diabetes, Dyslipidemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- Aug 2015
- Primary completion
- 27 Feb 2017 (actual)
- Study completion
- 27 Feb 2017 (actual)
- First posted
- 28 Oct 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.
A Multi-center, Randomized, double-blind, active-controlled, phase 3 trial to evaluate the safety and efficacy of Metformin/Atorvastatin in subjects with Type II Diabetes and dyslipidemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Metformin/Atorvastatin | Active comparator | Drug: Metformin/Atorvastatin 1500mg/40mg, QDMetformin/Atorvastatin, QD |
| Metformin | Placebo comparator | Drug: Atorvastatin 40mg, QDMetformin, QD |
| Atorvastatin | Placebo comparator | Drug: Metformin 1500mg, QDAtorvastatin, QD |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects with Dyslipidemia and Type II Diabetes
- 19 years later, men and women under the age of 80
Key exclusion criteria (3 listed)
- Pregnant women, nursing mothers or subject who does not agree to assigned contraception in the study
- Subject with type I Diabetes
- Subject with hypertension which does not controlled by treatment(have blood pressure > 180/110mmHg)
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/Atorvastatin 1500mg/40mg, QD | Drug | Metformin/Atorvastatin |
| Metformin 1500mg, QD | Drug | Atorvastatin |
| Atorvastatin 40mg, QD | Drug | Metformin |
Primary outcome
Change in HbA1c
Time frame: Change from baseline at 16 weeks
Change in HbA1c after 16 weeks, relative to baseline, between the combination of Metformin 1500 mg and Atorvastatin 40 mg compared to Atorvastatin 40 mg alone
Change in LDL Cholesterol
Time frame: Change from baseline at 16 weeks
Change in low-density lipoprotein cholesterol (LDL-C) after 16 weeks, relative to baseline, between Metformin 1500 mg alone and the combination of Metformin 1500 mg and Atorvastatin 40 mg
9 secondary outcomes
Change in LDL-C
Time frame: Baseline and 16 weeks
Change in HbA1c
Time frame: Baseline and 16 weeks
Percentage of subjects reaching the LDL-C treatment goal defined by the NCEP ATP III guideline (<100mg/dL) after 16 weeks of treatment with investigational products
Time frame: 16 weeks
Percentage of subjects reaching HbA1c <7.0% and <6.5% after 16 weeks of treatment with investigational products
Time frame: 16 weeks
Change in LDL-C and the associated rate of change after 4, 8, and 12 weeks of treatment with investigational products compared to baseline
Time frame: Baseline, 4 weeks, 8 weeks and 12 weeks
Change in LDL-C after 16 weeks, relative to baseline, in subjects treated with investigational products
Time frame: Baseline and 16 weeks
Change in lipid variables and the associated rate of change
Time frame: Baseline, 4 weeks, 8 weeks and 12 weeks and 16 weeks
Change in average fasting plasma glucose (FPG) after 4, 8, 12, and 16 weeks of treatment with investigational products compared to baseline
Time frame: Baseline, 4 weeks, 8 weeks and 12 weeks and 16 weeks
Change in Insulin, HOMA-β, HOMA-IR after 4, 8, 12, and 16 weeks of treatment with investigational products compared to baseline.
Time frame: Baseline, 4 weeks, 8 weeks and 12 weeks and 16 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 18 Jun 2023.
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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 3 study testing Metformin/Atorvastatin 1500mg/40mg, QD, Metformin 1500mg, QD and Atorvastatin 40mg, QD in people with Type II Diabetes and Dyslipidemia, run by Daewoong Pharmaceutical Co. LTD. 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 2 inclusion and 3 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 18 Jun 2023. 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. 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 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 in HbA1c (time frame: Change from baseline at 16 weeks). 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 18 Jun 2023.