Completed

Fix-dose Combination of Gemigliptin and Rosuvastatin for Type 2 Diabetes and Dyslipidemia

Study Aim

This study aims to evaluate the effectiveness of a fixed-dose combination of Gemigliptin and Rosuvastatin in reducing HbA1c and LDL-C levels in individuals with Type 2 Diabetes and Dyslipidemia.

What is being tested

Gemigliptin and/or Rosuvastatin

Drug

Who is being recruted

Diabetes Mellitus+5

+ Diabetes Mellitus, Type 2

+ Endocrine System Diseases

Over 19 Years

+7 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-ControlledPhase 3

Interventional

Study Start: May 2014

See protocol details

Summary

Principal SponsorLG Life Sciences

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2014

Actual date on which the first participant was enrolled.

To evaluate the efficacy and safety of the fix-dose combination therapy with Gemigliptin 50mg and Rosuvastatin 20mg with type 2 diabetes and dyslipidemia

Official TitleA Multicenter, Randomized, Placebo-controlled, Double-blind, Phase III Trial to Evaluate the Efficacy and Safety of the Fix-dose Combination Therapy With Gemigliptin 50mg and Rosuvastatin 20mg With Type 2 Diabetes and Dyslipidemia

NCT02126358

Principal SponsorLG Life Sciences

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

290 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 19 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diabetes MellitusDiabetes Mellitus, Type 2Endocrine System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism DisordersDyslipidemiasLipid Metabolism Disorders

Criteria

2 inclusion criteria required to participate

Type 2 Diabetes Mellitus with Dyslipidemia

Adults who are at least 19 years old

5 exclusion criteria prevent from participating

Patients with type 1 diabetes, diabetic ketoacidosis, diabetic coma and pre-coma

Patients with gestational diabetes or secondary diabetes

Patients with NYHA Class III, IV congestive heart failure or arrhythmias requiring treatment

Patients with thyroid gland dysfunction deviating from the normal TSH range

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

3 intervention groups are designated in this study

66.667% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

Gemigliptin \& Rosuvastatin (Gemiglitpin only:Placebo ,Rosuvastatin only:Placebo)

Group II

Placebo

only Gemiglitpin (Gemiglitpin/Rosuvastatin FDC:Placebo , Rosuvastatin :Placebo)

Group III

Placebo

only Rosuvastatin (Gemiglitpin/Rosuvastatin FDC:Placebo , gemigliptin :Placebo)

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Severance hospital

Seoul, South KoreaOpen Severance hospital in Google Maps

CompletedOne Study Center