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

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)

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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