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

LG Life Sciences

Status and phase: Completed; Phase 3

Conditions: Dyslipidemia; Type 2 Diabetes

Treatments: Drug: Gemigliptin and/or Rosuvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02126358

LG-GSCL002

Details and patient eligibility

About

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

Enrollment: 290 patients

Sex: All

Ages: 19+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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290 participants in 3 patient groups, including a placebo group

Gemigliptin

Placebo Comparator group

Description:

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

Treatment:

Drug: Gemigliptin and/or Rosuvastatin

Rosuvastatin

Placebo Comparator group

Description:

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

Treatment:

Drug: Gemigliptin and/or Rosuvastatin

FDC

Experimental group

Description:

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

Treatment:

Drug: Gemigliptin and/or Rosuvastatin