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

October 17, 2016 updated by: LG Life Sciences

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

290

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Gemigliptin
only Gemiglitpin (Gemiglitpin/Rosuvastatin FDC:Placebo , Rosuvastatin :Placebo)
Drug: Gemigliptin and/or Rosuvastatin
Placebo Comparator: Rosuvastatin
only Rosuvastatin (Gemiglitpin/Rosuvastatin FDC:Placebo , gemigliptin :Placebo)
Drug: Gemigliptin and/or Rosuvastatin
Experimental: FDC
Gemigliptin & Rosuvastatin (Gemiglitpin only:Placebo ,Rosuvastatin only:Placebo)
Drug: Gemigliptin and/or Rosuvastatin

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LG Life Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

March 4, 2014

First Submitted That Met QC Criteria

April 29, 2014

First Posted (Estimate)

April 30, 2014

Study Record Updates

Last Update Posted (Estimate)

October 18, 2016

Last Update Submitted That Met QC Criteria

October 17, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LG-GSCL002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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