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) | Biotech Hunter

Enrollment

315

Participants

Timeline

Start Date

May 13, 2019

Primary Completion Date

May 20, 2021

Study Completion Date

November 30, 2022

Conditions

Diabetes Mellitus, Type 2

Interventions

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"

Trial Locations (1)

07795

LG chem, Seoul