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

NCT04255238 | Unknown Phase 3

• 1 other identifier: LG-GLCL001
• Study Type: interventional
• Target: 468
• Locations: 0 countries
• Sites: N/A

Brief 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 diabetes mellitus who have inadequate glycemic control on metformin alone

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Chages from baseline HbA1c at Week24

  Baseline to Week24

Study Arms (3)

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

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

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

Drug: Dapagliflozin 10mg

Interventions

Gemigliptin 50mg DRUG

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

Also known as: Zemiglo tab 50mg

Gemigliptin 50 mg and Dapagliflozin 10 mg; Gemigliptin 50 mg and Dapagliflozin placebo

Dapagliflozin 10mg DRUG

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

Also known as: Forxiga tab 10mg

Gemigliptin 50 mg and Dapagliflozin 10 mg; Gemigliptin placebo and Dapagliflozin 10mg

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• (Screening) applicable to the criteria below
• Bilirubin \>2 × upper limit of normal(ULN)

Sponsors & Collaborators

• LG Chem: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

LC15-0444; dapagliflozin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Eunjoo Cho

CONTACT

+82-2-6987-4284; eunjoo.cho@lgchem.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2020
• First Posted: February 5, 2020
• Study Start: June 30, 2020
• Primary Completion: May 30, 2022
• Study Completion: December 30, 2022
• Last Updated: February 19, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share