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NCT01903070 Clinical Trial

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

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01903070
Other study ID # 00/0594-LINARI
Secondary ID
Status Completed
Phase Phase 4
First received July 11, 2013
Last updated March 1, 2017
Start date July 11, 2013
Est. completion date April 2016

Study information
Verified date March 2017
Source Profil Institut für Stoffwechselforschung GmbH
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 99
Est. completion date April 2016
Est. primary completion date April 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Linagliptin

Locations
Country Name City State
Germany Profil Institut für Stoffwechselforschung GmbH Neuss NRW

Sponsors (1)
Lead Sponsor Collaborator
Profil Institut für Stoffwechselforschung GmbH

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary ?AUCGLP-1-OGTT(0-240) ?AUCGLP-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
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