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

February 17, 2020 updated by: LG Chem

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
468

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

    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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Gemigliptin 50 mg and Dapagliflozin 10 mg
  • 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
Drug: Gemigliptin 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
Other Names:
  • Zemiglo tab 50mg
Drug: Dapagliflozin 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
Other Names:
  • Forxiga tab 10mg
Active Comparator: Gemigliptin 50 mg and Dapagliflozin placebo
  • 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
Drug: Gemigliptin 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
Other Names:
  • Zemiglo tab 50mg
Active Comparator: Gemigliptin placebo and 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
Drug: Dapagliflozin 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
Other Names:
  • Forxiga tab 10mg

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Chages from baseline HbA1c at Week24
Time Frame: Baseline to Week24
Baseline to Week24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
LG Chem

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 30, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 2, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 5, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 19, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LG-GLCL001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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