NCT03842267

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)

A Multicenter, Randomized, Placebo-controlled, Parallel Group, Double-blind, Phase III Study to Evaluate the Efficacy and Safety of Gemigliptin 50mg in Patients With Type 2 Diabetes Who Have Inadequate glycemIc Control With Dapagliflozin and Metformin (SOLUTION Study)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 315 (actual)
• Sponsor: LG Chem · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Gemigliptin 50mg	* 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
DRUG	Gemigliptin Placebo	* 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

Timeline

• Start date: 2019-05-13
• Primary completion: 2021-05-20
• Completion: 2022-11-30
• First posted: 2019-02-15
• Last updated: 2023-03-10

Locations

1 site across 1 country: South Korea