NCT01990469

Brief Summary

After a screening, a 2-week, single-blind placebo run-in, 174 patients will be randomized in a 1 : 1 ratio to the addition of either once-daily Gemigliptin 50 mg or placebo to ongoing stable doses of glimepiride in combination with metformin for 24 weeks.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
219

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2014

Shorter than P25 for phase_3

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

November 15, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 21, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

April 19, 2016

Status Verified

April 1, 2016

Enrollment Period

1.2 years

First QC Date

November 15, 2013

Last Update Submit

April 18, 2016

Conditions

T2DM

Keywords

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Change of HbAlc from baseline at Week 24

    24 weeks

Study Arms (2)

Gemigliptin

EXPERIMENTAL

Gemigliptin 50mg qd

Drug: Gemigliptin

Placebo

PLACEBO COMPARATOR

Gemigliptin placebo

Drug: Gemigliptin placebo

Interventions

GemigliptinDRUG

DPP-4 inhibitor

Also known as: Zemiglo
Gemigliptin
Gemigliptin placeboDRUG

Placebo of Gemigliptin

Placebo

Eligibility Criteria

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

You may qualify if:

  • Patients with Type 2 Diabetes Mellitus
  • Adults aged ≥ 19 years old
  • Patients with HbA1c 7%\~11% at Visit 1

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

LC15-0444

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

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

November 15, 2013

First Posted

November 21, 2013

Study Start

January 1, 2014

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

April 19, 2016

Record last verified: 2016-04