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

NCT ID: NCT01903070

Last Updated: 2017-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-11

Study Completion Date

2016-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Linagliptin in TD2 subjects

Linagliptin in TD2 subjects with normal renal function

Group Type EXPERIMENTAL

Linagliptin

Intervention Type DRUG

Linagliptin in TD2 subjects with impaired renal function

Linagliptin in TD2 subjects with impaired renal function

Group Type EXPERIMENTAL

Linagliptin

Intervention Type DRUG

Interventions

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Linagliptin

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Profil Institut für Stoffwechselforschung GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christoph Kapitza, MD

Role: PRINCIPAL_INVESTIGATOR

Profil Institut für Stoffwechselforschung GmbH

Locations

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Profil Institut für Stoffwechselforschung GmbH

Neuss, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

Other Identifiers

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00/0594-LINARI

Identifier Type: -

Identifier Source: org_study_id

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