Type 2 DiabetesPhase 3NCT02126358
Gemigliptin-Rosuvastatin Fix-dose Combination Phase 3(BALANCE)
A Phase 3 study testing Gemigliptin and/or Rosuvastatin in people with Type 2 Diabetes and Dyslipidemia, run by LG Life Sciences at 1 site in South Korea.
Trial summary
To evaluate the efficacy and safety of the fix-dose combination therapy with Gemigliptin 50mg and Rosuvastatin 20mg 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?
- Gemigliptin and/or Rosuvastatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 290 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2014to Mar 2016
- 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
- Type 2 Diabetes Mellitus with Dyslipidemia
- Adults who are at least 19 years old
Who cannot join
- Patients with type 1 diabetes, diabetic ketoacidosis, diabetic coma and pre-coma
- Patients with gestational diabetes or secondary diabetes
- Patients with NYHA Class III, IV congestive heart failure or arrhythmias requiring treatment
- Patients with thyroid gland dysfunction deviating from the normal TSH range
- Patients with pituitary insufficiency or adrenal insufficiency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Placebo-controlled, Double-blind, Phase III Trial to Evaluate the Efficacy and Safety of the Fix-dose Combination Therapy With Gemigliptin 50mg and Rosuvastatin 20mg With Type 2 Diabetes and Dyslipidemia
To evaluate the efficacy and safety of the fix-dose combination therapy with Gemigliptin 50mg and Rosuvastatin 20mg with type 2 diabetes and dyslipidemia
- Conditions
- Type 2 Diabetes, Dyslipidemia
- Being tested
- Gemigliptin and/or Rosuvastatin
- 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.
Gemigliptin and/or RosuvastatinDrug
| Study group | Role | What they receive |
|---|---|---|
| Gemigliptin | Placebo comparator | only Gemiglitpin (Gemiglitpin/Rosuvastatin FDC:Placebo , Rosuvastatin :Placebo) Receives: Drug: Gemigliptin and/or Rosuvastatin |
| Rosuvastatin | Placebo comparator | only Rosuvastatin (Gemiglitpin/Rosuvastatin FDC:Placebo , gemigliptin :Placebo) Receives: Drug: Gemigliptin and/or Rosuvastatin |
| FDC | Experimental | Gemigliptin \& Rosuvastatin (Gemiglitpin only:Placebo ,Rosuvastatin only:Placebo) Receives: Drug: Gemigliptin and/or Rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c change
Measured: Baseline(Day 0) to Treatment (last visit, w24)
LDL-C change rate
Measured: Baseline(Day 0) to Treatment (last visit, w24)
Secondary outcomes (2)
HbA1c
(Gemigliptin/Rosuvastatin FDC vs. Gemigliptin)
Measured: Baseline(Day 0) to Treatment (last visit, w24)
LDL-C change rate
(Gemigliptin/Rosuvastatin FDC vs. Rosuvastatin)
Measured: Baseline(Day 0) to Treatment (last visit, w24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2014 (estimated)
- Study startMay 2014
- Primary completionMar 2016
- Study completionMar 2016
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- LG Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02126358
- Sponsor's protocol ID
- LG-GSCL002
- Status last verified
- Oct 2016
- First submitted
- 4 Mar 2014
- Last updated
- 18 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Placebo-controlled, Double-blind, Phase III Trial to Evaluate the Efficacy and Safety of the Fix-dose Combination Therapy With Gemigliptin 50mg and Rosuvastatin 20mg With Type 2 Diabetes and Dyslipidemia
- ClinicalTrials.gov ID
- NCT02126358
- Acronym / sponsor ID
- LG-GSCL002
- Conditions
- Type 2 Diabetes, Dyslipidemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- LG Life SciencesIndustry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 30 Apr 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.
To evaluate the efficacy and safety of the fix-dose combination therapy with Gemigliptin 50mg and Rosuvastatin 20mg with type 2 diabetes and dyslipidemia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gemigliptin | Placebo comparator | Drug: Gemigliptin and/or Rosuvastatinonly Gemiglitpin (Gemiglitpin/Rosuvastatin FDC:Placebo , Rosuvastatin :Placebo) |
| Rosuvastatin | Placebo comparator | Drug: Gemigliptin and/or Rosuvastatinonly Rosuvastatin (Gemiglitpin/Rosuvastatin FDC:Placebo , gemigliptin :Placebo) |
| FDC | Experimental | Drug: Gemigliptin and/or RosuvastatinGemigliptin \& Rosuvastatin (Gemiglitpin only:Placebo ,Rosuvastatin only:Placebo) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Type 2 Diabetes Mellitus with Dyslipidemia
- Adults who are at least 19 years old
Key exclusion criteria (5 listed)
- Patients with type 1 diabetes, diabetic ketoacidosis, diabetic coma and pre-coma
- Patients with gestational diabetes or secondary diabetes
- Patients with NYHA Class III, IV congestive heart failure or arrhythmias requiring treatment
- Patients with thyroid gland dysfunction deviating from the normal TSH range
- Patients with pituitary insufficiency or adrenal insufficiency
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 |
|---|---|---|
| Gemigliptin and/or Rosuvastatin | Drug | FDC, Gemigliptin, Rosuvastatin |
Primary outcome
HbA1c change
Time frame: Baseline(Day 0) to Treatment (last visit, w24)
LDL-C change rate
Time frame: Baseline(Day 0) to Treatment (last visit, w24)
2 secondary outcomes
HbA1c
Time frame: Baseline(Day 0) to Treatment (last visit, w24)
LDL-C change rate
Time frame: Baseline(Day 0) to Treatment (last visit, w24)
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 Oct 2016.
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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 Gemigliptin and/or Rosuvastatin in people with Type 2 Diabetes and Dyslipidemia, run by LG Life Sciences 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 5 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 Oct 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. 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?
HbA1c change (time frame: Baseline(Day 0) to Treatment (last visit, w24)). 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 Oct 2016.