Diabetes Mellitus, Type 2Phase 3NCT03842267
A Study to Evaluate the Efficacy and Safety of Gemigliptin in Type 2 Diabetes Who Have Inadequate GlycemIc Control With Dapagliflozin and Metformin (SOLUTION Study)
A Phase 3 study testing Gemigliptin 50mg in people with Diabetes Mellitus, Type 2, run by LG Chem at 1 site in South Korea.
Trial summary
The objective of this study is to evaluate the efficacy and safety of gemigliptin 50 mg orally administered once daily for 24 weeks compared with placebo in patients with type 2 diabetes mellitus who have inadequate glycemic control with dapagliflozin and metformin Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Gemigliptin 50mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 315 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 May 2019to 30 Nov 2022
- 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 mellitus of upper 19 years old at the time of Visit 1 (Screening)
- Visit 1 (Screening) Patients who had taken Dapagliflozin 10mg/day and Metformin(≥1000mg/day) more than 8 weeks and who have inadequate blood glucose control at Visit 1 (Screening)
- Patients who have signed an informed consent themselves after receiving explanation about the objectives, methods, effects, etc. of the clinical study
- Patients who are applicable to one of the three in the following. 1) Surgically infertile patients 2) Postmenopausal female patients of ≥45 years of age for whom ≥2 years elapsed since their last menstruation 3) Premenopausal fertile female patients or surgically non-infertile male patients who have agreed to use at least 2 kinds of contraceptive measures (certainly including one of the barrier methods) to avoid pregnancy until 14 days after the last dose of the investigational product
- Barrier methods: Condom, Diaphragm, Cervical cap(Pessary), Spermicide
- Hormonal methods: Pills, Injection(Depot), Skin patch, Hormonal implant(Implanon), Vaginal ring
- Intrauterine Devices(IUDs): Cooper IUD(Loop), Hormonal IUD(Mirena)
- Natural methods: Basic body temperature, Ovulation period, Coitus interruptus, Abstinence
Who cannot join
- Patients with type 1 diabetes mellitus, Diabetic ketoacidosis, Metabolic acidosis Diabetic coma, Diabetic pre-coma
- Patients with Gestational diabetes, or secondary diabetes
- Patients with Body Mass Index(BMI) >40 kg/m2 at the time of Visit 1(Screening)
- Patients with a history of the following
- Patients with NYHA Class II~IV congestive heart failure or arrhythmia requiring treatment at the time of Visit 1(Screening)
- Patients whose TSH level is out of the normal range and who have thyroidal dysfunction requiring drug therapy at the time of Visit 1(Screening) (However, those who have been taking thyroid hormone at a fixed dose since previous 4 weeks prior to Visit 1(Screening) and whose TSH level is within the normal range can participate in the study.)
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- Patients with a glomerular filtration rate (eGFR) less than 45 mL/min /1.73 m2, moderate of severe stage renal disease, end-stage renal disease, dialysis at the time of Visit 1(Screening)
- Patients who are receiving intravenous iodine contrast agents within 48 hours prior to Visit 1(Screening) or planned during the clinical trial period (eg, intravenous urography, venous cholangiography, angiography, computed tomography using contrast media, etc.).
- Patients with pulmonary embolism, severe pulmonary dysfunction, or who are susceptible to be accompanied by hypoxemia at the time of Visit 1(Screening)
- Patients on dehydration, diarrhea, and vomiting at the time of Visit 1(Screening)
- Patients with pituitary insufficiency or adrenal insufficiency at the time of Visit 1(Screening)
- Patients with a history of myocardial infarction, unstable angina, and Cerebrovascular disease within 12 weeks prior to Visit 1(Screening)
- Patients who had had a surgical operation within 4 weeks prior to Visit 1(Screening) (excluding minor surgeries without restriction on food and fluid intake) or who are scheduled to have a significant surgery during the study period
- Patients with a history of alcoholism or drug addiction within 1 years prior to Visit 1(Screening)
- Patients with a history of malignant tumors within 5 years prior to Visit 1(Screening). However, patients with basal cell or squamous cell skin cancer, or in situ cervical cancer treated properly can participate in the study.
- Patients with the outcomes of the laboratory tests performed at Visit 1(Screening) applicable to the criteria below
- Bilirubin >2 × upper limit of normal(ULN)
- AST/ALT >3 × ULN
- Patients with a history of hypersensitivity reactions to the drugs below
- Dipeptidyl-peptidase4(DPP4) inhibitors
- Sodium/glucose co transport-2(SGLT-2) inhibitor
- Biguanides
- Patients who were administered the drugs below
- Patients who had been administered anti-obesity drugs within 12 weeks prior to Visit 1(Screening)
- Patients who had been administered insulin or GLP-1 analogues within 8 weeks prior to Visit 1(Screening)
- Patients who had been being administered glucocorticoids, Strong CYP3A4 inducers continuously within 2 weeks prior to Visit 1(Screening) or who are required to take glucocorticoids continuously in the future
- Patients with positive Serologic results of HBsAg, HCV Ab, HIV Ab test within 4 weeks prior to Visit 1 (Screening) or at Visit 1 (Screening)
- Patients who have undergone bariatric surgery within the 1 year prior to Visit 1 (Screening) or are scheduled during the trial
- Patients with a genetic problems such as Galactose intolerance, Lapp lactose deficiency, Glucose-galactose malabsorption)
- Female patients who are pregnant or lactating
- Patients who have an experience of participation in another clinical study within 12 weeks prior to Visit1(screening)
- Patients who are otherwise considered to be ineligible for this study on investigators' judgment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Placebo-controlled, Parallel Group, Double-blind, Phase III Study to Evaluate the Efficacy and Safety of Gemigliptin 50mg in Patients With Type 2 Diabetes Who Have Inadequate glycemIc Control With Dapagliflozin and Metformin (SOLUTION Study)
The objective of this study is to evaluate the efficacy and safety of gemigliptin 50 mg orally administered once daily for 24 weeks compared with placebo in patients with type 2 diabetes mellitus who have inadequate glycemic control with dapagliflozin and metformin
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Gemigliptin 50mg, Gemigliptin Placebo
- 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 50mgDrug
- The subjects should visit a study site 9 times during the treatment period for about 52 weeks in total.
- Background therapy should be administered at the same time every day, keeping the same dosage administered before the study, according to the following criteria:
- Dapagliflozin 10 mg / day
- Metformin ≥ 1,000 mg / day
Gemigliptin PlaceboDrug
- The subjects should visit a study site 9 times during the treatment period for about 52 weeks in total.
- - The subjects should visit a study site 9 times during the treatment period for about 52 weeks in total.
- Background therapy should be administered at the same time every day, keeping the same dosage administered before the study, according to the following criteria:
- Dapagliflozin 10 mg / day
- Metformin ≥ 1,000 mg / day
| Study group | Role | What they receive |
|---|---|---|
| Gemigliptin 50mg | Active comparator | Not described Receives: Drug: Gemigliptin 50mg |
| Gemigliptin Placebo | Placebo comparator | Not described Receives: Drug: Gemigliptin Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline HbA1c at week 24
Measured: Baseline (week 0) and week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start13 May 2019
- Primary completion20 May 2021
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- 315 participants (actual)
Sponsor and investigators
- Lead sponsor
- LG Chem
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03842267
- Sponsor's protocol ID
- LG-DPCL019
- Status last verified
- Mar 2023
- First submitted
- 13 Feb 2019
- Last updated
- 10 Mar 2023
- Results posted
- No
- 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 10 Mar 2023. 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 Study to Evaluate the Efficacy and Safety of Gemigliptin 50mg in Patients With Type 2 Diabetes Who Have Inadequate glycemIc Control With Dapagliflozin and Metformin (SOLUTION Study)
- ClinicalTrials.gov ID
- NCT03842267
- Acronym / sponsor ID
- LG-DPCL019
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 315 participants (actual)
- Lead sponsor
- LG ChemIndustry (pharma, biotech, devices)
- Study start
- 13 May 2019 (actual)
- Primary completion
- 20 May 2021 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 15 Feb 2019 (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.
The objective of this study is to evaluate the efficacy and safety of gemigliptin 50 mg orally administered once daily for 24 weeks compared with placebo in patients with type 2 diabetes mellitus who have inadequate glycemic control with dapagliflozin and metformin
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gemigliptin 50mg | Active comparator | Drug: Gemigliptin 50mg |
| Gemigliptin Placebo | Placebo comparator | Drug: Gemigliptin Placebo |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with type 2 diabetes mellitus of upper 19 years old at the time of Visit 1 (Screening)
- Visit 1 (Screening) Patients who had taken Dapagliflozin 10mg/day and Metformin(≥1000mg/day) more than 8 weeks and who have inadequate blood glucose control at Visit 1 (Screening)
- Patients who have signed an informed consent themselves after receiving explanation about the objectives, methods, effects, etc. of the clinical study
- Patients who are applicable to one of the three in the following. 1) Surgically infertile patients 2) Postmenopausal female patients of ≥45 years of age for whom ≥2 years elapsed since their last menstruation 3) Premenopausal fertile female patients or surgically non-infertile male patients who have agreed to use at least 2 kinds of contraceptive measures (certainly including one of the barrier methods) to avoid pregnancy until 14 days after the last dose of the investigational product
Key exclusion criteria (32 listed)
- Patients with type 1 diabetes mellitus, Diabetic ketoacidosis, Metabolic acidosis Diabetic coma, Diabetic pre-coma
- Patients with Gestational diabetes, or secondary diabetes
- Patients with Body Mass Index(BMI) >40 kg/m2 at the time of Visit 1(Screening)
- Patients with a history of the following
- Patients with the outcomes of the laboratory tests performed at Visit 1(Screening) applicable to the criteria below
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 50mg* The subjects should visit a study site 9 times during the treatment period for about 52 weeks in total. * Background therapy should be administered at the same time every day, keeping the same dosage administered before the study, according to the following criteria: 1. Dapagliflozin 10 mg / day 2. Metformin ≥ 1,000 mg / day | Drug | Gemigliptin 50mg |
| Gemigliptin Placebo* The subjects should visit a study site 9 times during the treatment period for about 52 weeks in total. * - The subjects should visit a study site 9 times during the treatment period for about 52 weeks in total. * Background therapy should be administered at the same time every day, keeping the same dosage administered before the study, according to the following criteria: 1. Dapagliflozin 10 mg / day 2. Metformin ≥ 1,000 mg / day | Drug | Gemigliptin Placebo |
Primary outcome
Changes from baseline HbA1c at week 24
Time frame: Baseline (week 0) and week 24
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 10 Mar 2023.
- 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 3 study testing Gemigliptin 50mg in people with Diabetes Mellitus, Type 2, run by LG Chem 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 8 inclusion and 32 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 10 Mar 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?
Changes from baseline HbA1c at week 24 (time frame: Baseline (week 0) and 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 10 Mar 2023; AzTrials last refreshed its copy on 7 Nov 2026.