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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 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 315

Last updated 2023-03-10

No results posted yet for this study

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

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

Sponsors & Collaborators

  • LG Chem

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-13
Primary Completion
2021-05-20
Completion
2022-11-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03842267 on ClinicalTrials.gov