Diabetes Mellitus, Type 2Phase 3NCT04255238
A Study to Evaluate the Efficacy and Safety of Dual add-on Therapy With Gemigliptin 50 mg and Dapagliflozin 10 mg Added to Metformin Who Have Inadequate Glycemic Control on Metformin Alone
A Phase 3 study testing Gemigliptin 50mg and Dapagliflozin 10mg in people with Diabetes Mellitus, Type 2, run by LG Chem.
Trial summary
The objective of this study is to evaluate the efficacy and safety of dual add-on therapy with Gemigliptin 50 mg and Dapagliflozin 10 mg added to Metformin compared to add-on therapy with Gemigliptin 50 mg in combination with Metformin or Dapagliflozin 10 mg in combination with Metformin in patients with type 2… 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 and Dapagliflozin 10mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 468 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2020to 30 Dec 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
- Patients upper 19 years old
- Patients who had taken Metformin(≥1000mg/day) more than 8 weeks and who have inadequate blood glucose control
- Patients who have signed an informed consent themselves after receiving explanation about the clinical study
- Patients who are applicable to one of the three in the following.
- Surgically infertile patients
- Postmenopausal female patients of ≥45 years of age for whom ≥2 years elapsed since their last menstruation
- 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
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 NYHA Class II~IV congestive heart failure or arrhythmia requiring treatment
- Patients whose TSH level is out of the normal range and who have thyroidal dysfunction requiring drug therapy
- 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 with Body Mass Index(BMI) #40 kg/m2
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- 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 clinically significant 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 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 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
No sites are listed yet.
About this study
Official title: A Multicenter, Randomized, Double-blind, Double-dummy, Active-controlled, Parallel Group, Phase 3 Trial to Evaluate the Efficacy and Safety of Dual add-on Therapy With Gemigliptin 50 mg and Dapagliflozin 10 mg Added to Metformin Compared to add-on Therapy With Gemigliptin 50 mg in Combination With Metformin or Dapagliflozin 10 mg in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Alone
The objective of this study is to evaluate the efficacy and safety of dual add-on therapy with Gemigliptin 50 mg and Dapagliflozin 10 mg added to Metformin compared to add-on therapy with Gemigliptin 50 mg in combination with Metformin or Dapagliflozin 10 mg in combination with Metformin in patients with type 2 diabetes mellitus who have inadequate glycemic control on metformin alone
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Gemigliptin 50mg, Dapagliflozin 10mg
- 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
Also called Zemiglo tab 50mg
The subjects should visit a study site 6-7 times during the treatment period for about 24 weeks in total. - Background therapy should be administered keeping the same dosage administered before the study, according to the following criteria: Metformin ≥ 1,000 mg / day
Dapagliflozin 10mgDrug
Also called Forxiga tab 10mg
The subjects should visit a study site 6-7 times during the treatment period for about 24 weeks in total. - Background therapy should be administered keeping the same dosage administered before the study, according to the following criteria: Metformin ≥ 1,000 mg / day
| Study group | Role | What they receive |
|---|---|---|
| Gemigliptin 50 mg and Dapagliflozin 10 mg | Experimental | * Subject shoud took 1 tablet of Gemigliptin 50 mg and 1 tablet of Dapagliflozin 10 mg per day
* Background therapy should be administered keeping the same dosage administered before the study, according to the following criteria: Metformin ≥ 1,000 mg / day Receives: Drug: Gemigliptin 50mg; Drug: Dapagliflozin 10mg |
| Gemigliptin 50 mg and Dapagliflozin placebo | Active comparator | * Subject shoud took 1 tablet of Gemigliptin 50 mg and 1 tablet of Dapagliflozin placebo per day
* Background therapy should be administered keeping the same dosage administered before the study, according to the following criteria: Metformin ≥ 1,000 mg / day Receives: Drug: Gemigliptin 50mg |
| Gemigliptin placebo and Dapagliflozin 10mg | Active comparator | * Subject shoud took 1 tablet of Gemigliptin placebo and 1 tablet of Dapagliflozin 10 mg per day
* Background therapy should be administered keeping the same dosage administered before the study, according to the following criteria: Metformin ≥ 1,000 mg / day Receives: Drug: Dapagliflozin 10mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chages from baseline HbA1c at Week24
Measured: Baseline to Week24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start30 Jun 2020 (estimated)
- Primary completion30 May 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
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
- 468 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LG Chem
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04255238
- Sponsor's protocol ID
- LG-GLCL001
- Status last verified
- Feb 2020
- First submitted
- 2 Feb 2020
- Last updated
- 19 Feb 2020
- Results posted
- No
- Data monitoring committee
- 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 19 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Double-dummy, Active-controlled, Parallel Group, Phase 3 Trial to Evaluate the Efficacy and Safety of Dual add-on Therapy With Gemigliptin 50 mg and Dapagliflozin 10 mg Added to Metformin Compared to add-on Therapy With Gemigliptin 50 mg in Combination With Metformin or Dapagliflozin 10 mg in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Alone
- ClinicalTrials.gov ID
- NCT04255238
- Acronym / sponsor ID
- LG-GLCL001
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 468 participants (estimated)
- Lead sponsor
- LG ChemIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2020 (estimated)
- Primary completion
- 30 May 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 5 Feb 2020 (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 dual add-on therapy with Gemigliptin 50 mg and Dapagliflozin 10 mg added to Metformin compared to add-on therapy with Gemigliptin 50 mg in combination with Metformin or Dapagliflozin 10 mg in combination with Metformin in patients with type 2 diabetes mellitus who have inadequate glycemic control on metformin alone
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gemigliptin 50 mg and Dapagliflozin 10 mg | Experimental | Drug: Gemigliptin 50mg, Drug: Dapagliflozin 10mg* Subject shoud took 1 tablet of Gemigliptin 50 mg and 1 tablet of Dapagliflozin 10 mg per day * Background therapy should be administered keeping the same dosage administered before the study, according to the following criteria: Metformin ≥ 1,000 mg / day |
| Gemigliptin 50 mg and Dapagliflozin placebo | Active comparator | Drug: Gemigliptin 50mg* Subject shoud took 1 tablet of Gemigliptin 50 mg and 1 tablet of Dapagliflozin placebo per day * Background therapy should be administered keeping the same dosage administered before the study, according to the following criteria: Metformin ≥ 1,000 mg / day |
| Gemigliptin placebo and Dapagliflozin 10mg | Active comparator | Drug: Dapagliflozin 10mg* Subject shoud took 1 tablet of Gemigliptin placebo and 1 tablet of Dapagliflozin 10 mg per day * Background therapy should be administered keeping the same dosage administered before the study, according to the following criteria: Metformin ≥ 1,000 mg / day |
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
- Patients upper 19 years old
- Patients who had taken Metformin(≥1000mg/day) more than 8 weeks and who have inadequate blood glucose control
- Patients who have signed an informed consent themselves after receiving explanation about the clinical study
- Patients who are applicable to one of the three in the following.
Key exclusion criteria (27 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 NYHA Class II~IV congestive heart failure or arrhythmia requiring treatment
- Patients whose TSH level is out of the normal range and who have thyroidal dysfunction requiring drug therapy
- 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)
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 50mgAlso: Zemiglo tab 50mgThe subjects should visit a study site 6-7 times during the treatment period for about 24 weeks in total. - Background therapy should be administered keeping the same dosage administered before the study, according to the following criteria: Metformin ≥ 1,000 mg / day | Drug | Gemigliptin 50 mg and Dapagliflozin 10 mg, Gemigliptin 50 mg and Dapagliflozin placebo |
| Dapagliflozin 10mgAlso: Forxiga tab 10mgThe subjects should visit a study site 6-7 times during the treatment period for about 24 weeks in total. - Background therapy should be administered keeping the same dosage administered before the study, according to the following criteria: Metformin ≥ 1,000 mg / day | Drug | Gemigliptin 50 mg and Dapagliflozin 10 mg, Gemigliptin placebo and Dapagliflozin 10mg |
Primary outcome
Chages from baseline HbA1c at Week24
Time frame: Baseline to Week24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2020.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gemigliptin 50mg and Dapagliflozin 10mg in people with Diabetes Mellitus, Type 2, run by LG Chem.
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 27 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 19 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eunjoo Cho (+82-2-6987-4284, eunjoo.cho@lgchem.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chages from baseline HbA1c at Week24 (time frame: Baseline to Week24). 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 19 Feb 2020.