NCT02089126

Brief Summary

The study objective is to demonstrate the superiority and safety of the combination therapy (as a fix-dose combination) with Gemigliptin and Glimepiride, compared to the Glimepiride monotherapy in patients with type 2 diabetes.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
230

participants targeted

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

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 17, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Last Updated

March 17, 2014

Status Verified

March 1, 2014

Enrollment Period

2.3 years

First QC Date

March 13, 2014

Last Update Submit

March 14, 2014

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • HbA1c Changes

    Week 0, Week 24

Study Arms (2)

Gemigliptin/Glimepiride combination

EXPERIMENTAL

Gemigliptin 50mg qd added to ongoing Glimepiride as fix-dose combination. The subjects will take a total of 2 tablets, Gemigliptin/Glimepiride combination \& Placebo for Glimepiride.

Drug: Gemigliptin/Glimepiride combination

Placebo

PLACEBO COMPARATOR

The subjects will take a total of 2 tablets, Placebo for Gemigliptin/Glimepiride combination \& Glimepiride.

Interventions

Gemigliptin/Glimepiride combinationDRUG
Gemigliptin/Glimepiride combination

Eligibility Criteria

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

You may qualify if:

  • Patients with type 2 diabetes
  • Adults who are at least 19 years old
  • Patients who have taken Glimepiride at a stable dose (≥4mg/day) for 8 weeks or more before Visit 1 (screening) as monotherapy or Patients who have taken Glimepiride at a stable dose (≥4mg/day) and Metformin for 8 weeks or more before Visit 1 (screening) as combination therapy
  • Patients who satisfy the following HbA1c (%) criteria: 7 ≤ HbA1c ≤ 11
  • Patients who have been provided an explanation about the objective, method, effects, etc. of the clinical trial and whose informed consent form has been signed by himself/herself or his/her representative
  • Patients who fall under one of the following 3 cases
  • Patients who are surgically sterile
  • Post-menopausal females who are above 45 years of age and 2 years after the last menstruation
  • Fertile premenopausal female patients or male patients without having a surgical sterilization, who have agreed to use at least two contraception methods (one of the barrier methods must be included) for up to 14 days after the administration of the last investigational product to avoid pregnancy.

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 and TSH that is out of normal range
  • Patients with pituitary insufficiency or adrenal insufficiency
  • Patients with hereditary problems, such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption
  • Female patients who are pregnant or breastfeeding
  • Patients whose BMI exceeds 40 kg/m2
  • Patients whose creatinine clearance is below 30mL/min/1.73m2
  • Patients whose bilirubin level exceeds 1.5 times the upper limit of the normal range and whose ALT/AST level exceeds 2.5 times the upper limit of the normal range
  • Patients who are continuously taking the following drugs for 2 weeks or more at Visit 1 (screening), or need to take them continuously and repeatedly
  • cyclosporin, sirolimus, tacrolimus, nicotinic acid (≥1500mg/day), isotretinoin
  • Strong CYP3A4 inducers: rifampicin (rifampin), phenytoin, carbamazepine, rifabutin, phenobarbital
  • warfarin, dicoumarin, digoxin
  • systemic glucocorticoids
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Catholic University of Korea Seoul St. Mary's Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

LC15-0444

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Central Study Contacts

Jong Hee Jin

CONTACT

82-2-6924-3122jonghee@lgls.com

Study Design

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

Study Record Dates

First Submitted

March 13, 2014

First Posted

March 17, 2014

Study Start

June 1, 2014

Primary Completion

September 1, 2016

Last Updated

March 17, 2014

Record last verified: 2014-03

Locations

KR(1)