Gemigliptin-Rosuvastatin Fix-dose Combination Phase 3(BALANCE)

LG Life Sciences290 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

290

Conditions

Type 2 Diabetes Dyslipidemia

Interventions

Gemigliptin and/or RosuvastatinDRUG

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Type 2 Diabetes Mellitus with Dyslipidemia * Adults who are at least 19 years old Exclusion Criteria: * 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 * Patients with pituitary insufficiency or adrenal insufficiency

Locations (1)

Severance hospital

Seoul, South Korea

Outcomes

Primary Outcomes

HbA1c change

Time frame: Baseline(Day 0) to Treatment (last visit, w24)

LDL-C change rate

Time frame: Baseline(Day 0) to Treatment (last visit, w24)

Secondary Outcomes

HbA1c

(Gemigliptin/Rosuvastatin FDC vs. Gemigliptin)

Time frame: Baseline(Day 0) to Treatment (last visit, w24)

LDL-C change rate

(Gemigliptin/Rosuvastatin FDC vs. Rosuvastatin)

Time frame: Baseline(Day 0) to Treatment (last visit, w24)

Data from ClinicalTrials.gov

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