Effects of Linagliptin on Active GLP-1 Concentrations in Subjects With Renal Impairment

March 1, 2017 updated by: Profil Institut für Stoffwechselforschung GmbH

EFFECTS OF LINAGLIPTIN ON ACTIVE GLP-1 CONCENTRATIONS IN SUBJECTS WITH RENAL IMPAIRMENT

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

99

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Neuss, NRW, Germany, 41460
        • Profil Institut für Stoffwechselforschung GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Linagliptin in TD2 subjects
Linagliptin in TD2 subjects with normal renal function
Drug: Linagliptin
Experimental: Linagliptin in TD2 subjects with impaired renal function
Drug: Linagliptin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ΔAUCGLP-1-OGTT(0-240)
Time Frame: Glucose tolerance test following 7 days of therapy
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Profil Institut für Stoffwechselforschung GmbH

Investigators

  • Principal Investigator: Christoph Kapitza, MD, Profil Institut für Stoffwechselforschung GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 11, 2013

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

July 11, 2013

First Submitted That Met QC Criteria

July 16, 2013

First Posted (Estimate)

July 19, 2013

Study Record Updates

Last Update Posted (Actual)

March 3, 2017

Last Update Submitted That Met QC Criteria

March 1, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00/0594-LINARI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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