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)

NCT03842267 | Completed Phase 3

• 1 other identifier: LG-DPCL019
• Study Type: interventional
• Target: 315
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Changes from baseline HbA1c at week 24

  Baseline (week 0) and week 24

Study Arms (2)

Gemigliptin 50mg

ACTIVE COMPARATOR

Drug: Gemigliptin 50mg

Gemigliptin Placebo

PLACEBO COMPARATOR

Drug: Gemigliptin Placebo

Interventions

Gemigliptin 50mg DRUG

* 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

Gemigliptin 50mg

Gemigliptin Placebo DRUG

* 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

Gemigliptin Placebo

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 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

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 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.)
• 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.

Sponsors & Collaborators

• LG Chem: lead

Study Sites (1)

LG chem

Seoul, Gangseo-Gu, 07795, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

LC15-0444

Condition Hierarchy (Ancestors)

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

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 13, 2019
• First Posted: February 15, 2019
• Study Start: May 13, 2019
• Primary Completion: May 20, 2021
• Study Completion: November 30, 2022
• Last Updated: March 10, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)