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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02126358
• Other study ID #: LG-GSCL002
• Status: Completed
• Phase: Phase 3
• First received: March 4, 2014
• Last updated: October 17, 2016
• Start date: May 2014
• Est. completion date: March 2016

Study information

• Verified date: October 2016
• Source: LG Life Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 290
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Dyslipidemia
• Dyslipidemias
• Type 2 Diabetes

Intervention

Drug:
• Gemigliptin and/or Rosuvastatin

Locations

Country	Name	City	State
Korea, Republic of	Severance hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
LG Life Sciences

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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