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

A 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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02126358

Enrollment

290

Registered

2014-04-30

Start date

2014-05-31

Completion date

2016-03-31

Last updated

2016-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidemia, Type 2 Diabetes

Brief summary

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

Interventions

DRUGGemigliptin and/or Rosuvastatin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
HbA1c change	Baseline(Day 0) to Treatment (last visit, w24)
LDL-C change rate	Baseline(Day 0) to Treatment (last visit, w24)

Secondary

Measure	Time frame	Description
HbA1c	Baseline(Day 0) to Treatment (last visit, w24)	(Gemigliptin/Rosuvastatin FDC vs. Gemigliptin)
LDL-C change rate	Baseline(Day 0) to Treatment (last visit, w24)	(Gemigliptin/Rosuvastatin FDC vs. Rosuvastatin)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026