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 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: Unknown
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Gemigliptin 50mg; Drug: Dapagliflozin 10mg

• Study Type: Interventional
• Enrollment (Anticipated): 468
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Time Frame
Chages from baseline HbA1c at Week24	Baseline to Week24

Collaborators and Investigators

• Sponsor: LG Chem

Study record dates

Study Major Dates

• Study Start (Anticipated): June 30, 2020
• Primary Completion (Anticipated): May 30, 2022
• Study Completion (Anticipated): December 30, 2022

Study Registration Dates

• First Submitted: February 2, 2020
• First Submitted That Met QC Criteria: February 3, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): February 19, 2020
• Last Update Submitted That Met QC Criteria: February 17, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Sodium-Glucose Transporter 2 Inhibitors; Dapagliflozin
• Other Study ID 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