search
Back to results

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

Primary Purpose

Type 2 Diabetes, Dyslipidemia

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Gemigliptin and/or Rosuvastatin
Sponsored by
LG Life Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Severance hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Placebo Comparator

Experimental

Arm Label

Gemigliptin

Rosuvastatin

FDC

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

HbA1c change
LDL-C change rate

Secondary Outcome Measures

HbA1c
(Gemigliptin/Rosuvastatin FDC vs. Gemigliptin)
LDL-C change rate
(Gemigliptin/Rosuvastatin FDC vs. Rosuvastatin)

Full Information

First Posted
March 4, 2014
Last Updated
October 17, 2016
Sponsor
LG Life Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT02126358
Brief Title
Gemigliptin-Rosuvastatin Fix-dose Combination Phase 3(BALANCE)
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LG Life Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Dyslipidemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
290 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gemigliptin
Arm Type
Placebo Comparator
Arm Description
only Gemiglitpin (Gemiglitpin/Rosuvastatin FDC:Placebo , Rosuvastatin :Placebo)
Arm Title
Rosuvastatin
Arm Type
Placebo Comparator
Arm Description
only Rosuvastatin (Gemiglitpin/Rosuvastatin FDC:Placebo , gemigliptin :Placebo)
Arm Title
FDC
Arm Type
Experimental
Arm Description
Gemigliptin & Rosuvastatin (Gemiglitpin only:Placebo ,Rosuvastatin only:Placebo)
Intervention Type
Drug
Intervention Name(s)
Gemigliptin and/or Rosuvastatin
Primary Outcome Measure Information:
Title
HbA1c change
Time Frame
Baseline(Day 0) to Treatment (last visit, w24)
Title
LDL-C change rate
Time Frame
Baseline(Day 0) to Treatment (last visit, w24)
Secondary Outcome Measure Information:
Title
HbA1c
Description
(Gemigliptin/Rosuvastatin FDC vs. Gemigliptin)
Time Frame
Baseline(Day 0) to Treatment (last visit, w24)
Title
LDL-C change rate
Description
(Gemigliptin/Rosuvastatin FDC vs. Rosuvastatin)
Time Frame
Baseline(Day 0) to Treatment (last visit, w24)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Severance hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs