Type 2 Diabetes MellitusPhase 3NCT02089126
Phase III Trial to Evaluate the Efficacy and Safety of Gemigliptin 50mg qd Added to Ongoing Glimepiride as Fix-dose Combination in Patients With Type 2 Diabetes
A Phase 3 study testing Gemigliptin/Glimepiride combination in people with Type 2 Diabetes Mellitus, run by LG Life Sciences at 1 site in South Korea.
Trial summary
The study objective is to demonstrate the superiority and safety of the combination therapy (as a fix-dose combination) with Gemigliptin and Glimepiride, compared to the Glimepiride monotherapy in patients with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Gemigliptin/Glimepiride combination
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 230 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2014to Sep 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
- Patients with type 2 diabetes
- Adults who are at least 19 years old
- Patients who have taken Glimepiride at a stable dose (≥4mg/day) for 8 weeks or more before Visit 1 (screening) as monotherapy or Patients who have taken Glimepiride at a stable dose (≥4mg/day) and Metformin for 8 weeks or more before Visit 1 (screening) as combination therapy
- Patients who satisfy the following HbA1c (%) criteria: 7 ≤ HbA1c ≤ 11
- Patients who have been provided an explanation about the objective, method, effects, etc. of the clinical trial and whose informed consent form has been signed by himself/herself or his/her representative
- Patients who fall under one of the following 3 cases
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- Patients who are surgically sterile
- Post-menopausal females who are above 45 years of age and 2 years after the last menstruation
- Fertile premenopausal female patients or male patients without having a surgical sterilization, who have agreed to use at least two contraception methods (one of the barrier methods must be included) for up to 14 days after the administration of the last investigational product to avoid pregnancy.
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 and TSH that is out of normal range
- Patients with pituitary insufficiency or adrenal insufficiency
- Patients with hereditary problems, such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption
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- Female patients who are pregnant or breastfeeding
- Patients whose BMI exceeds 40 kg/m2
- Patients whose creatinine clearance is below 30mL/min/1.73m2
- Patients whose bilirubin level exceeds 1.5 times the upper limit of the normal range and whose ALT/AST level exceeds 2.5 times the upper limit of the normal range
- Patients who are continuously taking the following drugs for 2 weeks or more at Visit 1 (screening), or need to take them continuously and repeatedly
- cyclosporin, sirolimus, tacrolimus, nicotinic acid (≥1500mg/day), isotretinoin
- Strong CYP3A4 inducers: rifampicin (rifampin), phenytoin, carbamazepine, rifabutin, phenobarbital
- warfarin, dicoumarin, digoxin
- systemic glucocorticoids
- Patients who have taken anti-obesity drugs or had a surgery related to obesity within 12 weeks before Visit 1 (screening)
- Patients who have received insulin and GLP-1 analogue treatment within 8 weeks prior to Visit 1 (screening)
- Patients who have received a treatment due to malignant tumor within 5years before Visit 1 (screening) However, patients whose basal cell or squamous cell skin cancer or in situ cervical cancer has been treated can be enrolled.
- Patients with a history of myocardial infarction, unstable angina and coronary artery bypass surgery within 6 months prior to Visit 1 (screening)
- Patients with a history of alcohol or drug addiction within 1 year prior to Visit 1 (screening)
- Patients who have a medical history of hypersensitivity to the same class as Gemigliptin or dipeptidyl peptidase 4 (DPP 4) inhibitor drugs
- Patients with a history of hypersensitivity to the drugs belonging to the same class as Glimepiride or sulfonylureas and sulfonamide
- Patients who have participated in another clinical trial within 3 months prior to Visit 1 (screening)
- Patients deemed unsuitable for this trial based on the judgment of the investigator
Trial locations and contacts
1 site in 1 country.
South Korea1 site
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul
Cha, songppm@cmcnu.or.kr
About this study
Official title: A Multicenter, Randomized, Placebo-controlled, Parallel Group, Double-blind, Phase III Trial to Evaluate the Efficacy and Safety of Gemigliptin 50mg qd Added to Ongoing Glimepiride as Fix-dose Combination in Patients With Type 2 Diabetes Inadequately Controlled on Glimepiride Alone
The study objective is to demonstrate the superiority and safety of the combination therapy (as a fix-dose combination) with Gemigliptin and Glimepiride, compared to the Glimepiride monotherapy in patients with type 2 diabetes.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Gemigliptin/Glimepiride combination
- 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.
Gemigliptin/Glimepiride combinationDrug
| Study group | Role | What they receive |
|---|---|---|
| Gemigliptin/Glimepiride combination | Experimental | Gemigliptin 50mg qd added to ongoing Glimepiride as fix-dose combination. The subjects will take a total of 2 tablets, Gemigliptin/Glimepiride combination \& Placebo for Glimepiride. Receives: Drug: Gemigliptin/Glimepiride combination |
| Placebo | Placebo comparator | The subjects will take a total of 2 tablets, Placebo for Gemigliptin/Glimepiride combination \& Glimepiride. |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c Changes
Measured: Week 0, Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2014 (estimated)
- Study startJun 2014
- Primary completionSep 2016 (estimated)
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LG Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02089126
- Sponsor's protocol ID
- LG-GGCL001
- Status last verified
- Mar 2014
- First submitted
- 13 Mar 2014
- Last updated
- 17 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Placebo-controlled, Parallel Group, Double-blind, Phase III Trial to Evaluate the Efficacy and Safety of Gemigliptin 50mg qd Added to Ongoing Glimepiride as Fix-dose Combination in Patients With Type 2 Diabetes Inadequately Controlled on Glimepiride Alone
- ClinicalTrials.gov ID
- NCT02089126
- Acronym / sponsor ID
- LG-GGCL001
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- LG Life SciencesIndustry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Sep 2016 (estimated)
- First posted
- 17 Mar 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.
The study objective is to demonstrate the superiority and safety of the combination therapy (as a fix-dose combination) with Gemigliptin and Glimepiride, compared to the Glimepiride monotherapy in patients with type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gemigliptin/Glimepiride combination | Experimental | Drug: Gemigliptin/Glimepiride combinationGemigliptin 50mg qd added to ongoing Glimepiride as fix-dose combination. The subjects will take a total of 2 tablets, Gemigliptin/Glimepiride combination \& Placebo for Glimepiride. |
| Placebo | Placebo comparator | –The subjects will take a total of 2 tablets, Placebo for Gemigliptin/Glimepiride combination \& Glimepiride. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with type 2 diabetes
- Adults who are at least 19 years old
- Patients who have taken Glimepiride at a stable dose (≥4mg/day) for 8 weeks or more before Visit 1 (screening) as monotherapy or Patients who have taken Glimepiride at a stable dose (≥4mg/day) and Metformin for 8 weeks or more before Visit 1 (screening) as combination therapy
- Patients who satisfy the following HbA1c (%) criteria: 7 ≤ HbA1c ≤ 11
- Patients who have been provided an explanation about the objective, method, effects, etc. of the clinical trial and whose informed consent form has been signed by himself/herself or his/her representative
Key exclusion criteria (24 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 and TSH that is out of normal 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/Glimepiride combination | Drug | Gemigliptin/Glimepiride combination |
Primary outcome
HbA1c Changes
Time frame: Week 0, Week 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2014.
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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.
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/Glimepiride combination in people with Type 2 Diabetes Mellitus, 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 9 inclusion and 24 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: status not confirmed, as of the sponsor's last update on 17 Mar 2014. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jong Hee Jin (82-2-6924-3122, jonghee@lgls.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c Changes (time frame: Week 0, Week 24). 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 17 Mar 2014.