NCT01968044

Brief Summary

Therapuetic options are limited for Type 2 Diabetes Mellitus (T2DM) pateints with renal impairment. This clinical study is to asses safety and efficacy of the DPP-4 inhibitor gemigliptin in patients with type 2 DM and moderate or severe renal impairment for long-term peirod (52 weeks).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
132

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2013

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

Study Start

First participant enrolled

October 1, 2013

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

October 18, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 23, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

March 23, 2016

Status Verified

March 1, 2016

Enrollment Period

2 years

First QC Date

October 18, 2013

Last Update Submit

March 21, 2016

Conditions

Type 2 DM Patients With Moderate or Severe Renal Impairment

Keywords

renal impairment

Outcome Measures

Primary Outcomes (1)

  • HbA1c change

    HbA1c change from baseline to week 12

Secondary Outcomes (9)

  • HbA1c Change

    HbA1c change from baselint to week 6, 52

  • FPG

    FPG change from baseline to week 6,12,52

  • Glycated albumin

    Glycated albumin change from baseline to week 6,12,52

  • Fructosamin

    Fructosamin change from baseline to week 6,12,52

  • Waist

    Waist change from baseline to week 12,52

  • +4 more secondary outcomes

Study Arms (2)

Gemigliptin

EXPERIMENTAL

Participant will remain gemigliptin 50mg throughout entire study (52 weeks).

Drug: Gemigliptin

Placebo to linagliptin

OTHER

Participant who is randomized to placebo will be switched to linagliptin after 12 week and administered linagliptin by week 52.

Drug: Placebo to Linagliptin

Interventions

GemigliptinDRUG
Gemigliptin
Placebo to LinagliptinDRUG
Placebo to linagliptin

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with Type 2 Diabetes Mellitus
  • Patients with moderate or severe renal insufficiency
  • All patients give written informed consent

You may not qualify if:

  • Has type 1 diabetes mellitus or a history of ketoacidosis
  • Is on dialysis or is likely to need dialysis during the study
  • Has active liver disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Seoul, South Korea

Location

MeSH Terms

Conditions

Renal Insufficiency

Interventions

LC15-0444

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • DR Cha, MD, Ph.D

    Korea University Ansan Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 18, 2013

First Posted

October 23, 2013

Study Start

October 1, 2013

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

March 23, 2016

Record last verified: 2016-03

Locations

KR(1)