NCT02126358

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
290

participants targeted

Target at P25-P50 for phase_3 type-2-diabetes

Timeline
Completed

Started May 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 30, 2014

Completed
1 day until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

October 18, 2016

Status Verified

October 1, 2016

Enrollment Period

1.8 years

First QC Date

March 4, 2014

Last Update Submit

October 17, 2016

Conditions

Type 2 DiabetesDyslipidemia

Outcome Measures

Primary Outcomes (2)

  • HbA1c change

    Baseline(Day 0) to Treatment (last visit, w24)

  • LDL-C change rate

    Baseline(Day 0) to Treatment (last visit, w24)

Secondary Outcomes (2)

  • HbA1c

    Baseline(Day 0) to Treatment (last visit, w24)

  • LDL-C change rate

    Baseline(Day 0) to Treatment (last visit, w24)

Study Arms (3)

Gemigliptin

PLACEBO COMPARATOR

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

Drug: Gemigliptin and/or Rosuvastatin

Rosuvastatin

PLACEBO COMPARATOR

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

Drug: Gemigliptin and/or Rosuvastatin

FDC

EXPERIMENTAL

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

Drug: Gemigliptin and/or Rosuvastatin

Interventions

Gemigliptin and/or RosuvastatinDRUG
FDCGemigliptinRosuvastatin

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 Diabetes Mellitus with Dyslipidemia
  • Adults who are at least 19 years old

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Dyslipidemias

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesLipid Metabolism Disorders

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2014

First Posted

April 30, 2014

Study Start

May 1, 2014

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

October 18, 2016

Record last verified: 2016-10

Locations

KR(1)