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

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Profil Institut für Stoffwechselforschung

Status and phase

Completed
Phase 4

Conditions

Diabetes Mellitus

Treatments

Drug: Linagliptin

Study type

Interventional

Funder types

Industry

Identifiers

NCT01903070
00/0594-LINARI

Details and patient eligibility

About

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.

Enrollment

99 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

99 participants in 2 patient groups

Linagliptin in TD2 subjects
Experimental group
Description:
Linagliptin in TD2 subjects with normal renal function
Treatment:
Drug: Linagliptin
Linagliptin in TD2 subjects with impaired renal function
Experimental group
Description:
Linagliptin in TD2 subjects with impaired renal function
Treatment:
Drug: Linagliptin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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