NCT01903070

Brief Summary

This is a bi-centric, prospective, open study comparing the effects of linagliptin on active GLP-1 concentrations in subjects with renal impairment compared to subjects with normal renal function.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
99

participants targeted

Target at P50-P75 for phase_4 diabetes-mellitus

Timeline
Completed

Started Jul 2013

Typical duration for phase_4 diabetes-mellitus

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

July 11, 2013

Completed
Same day until next milestone

Study Start

First participant enrolled

July 11, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 19, 2013

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

March 3, 2017

Status Verified

March 1, 2017

Enrollment Period

2.7 years

First QC Date

July 11, 2013

Last Update Submit

March 1, 2017

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • ΔAUCGLP-1-OGTT(0-240)

    ΔAUCGLP-1-OGTT(0-240) Change in active GLP-1 concentrations after oral glucose ingestion after linagliptin Treatment compared between Groups.

    Glucose tolerance test following 7 days of therapy

Study Arms (2)

Linagliptin in TD2 subjects

EXPERIMENTAL

Linagliptin in TD2 subjects with normal renal function

Drug: Linagliptin

Linagliptin in TD2 subjects with impaired renal function

EXPERIMENTAL

Linagliptin in TD2 subjects with impaired renal function

Drug: Linagliptin

Interventions

LinagliptinDRUG
Linagliptin in TD2 subjectsLinagliptin in TD2 subjects with impaired renal function

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have Type 2 diabetes mellitus based on the disease diagnostic criteria (WHO) classification

You may not qualify if:

  • Subjects with type 1 diabetes, maturity onset diabetes of the young (MODY) or secondary forms of diabetes such as due to pancreatitis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Profil Institut für Stoffwechselforschung GmbH

Neuss, North Rhine-Westphalia, 41460, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Linagliptin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

PurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsQuinazolines

Study Officials

  • Christoph Kapitza, MD

    Profil Institut für Stoffwechselforschung GmbH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2013

First Posted

July 19, 2013

Study Start

July 11, 2013

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

March 3, 2017

Record last verified: 2017-03

Locations

DE(1)