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

Phase 4

Completed

• Conditions: Diabetes Mellitus
• Interventions: Drug: Linagliptin

• Registration Number: NCT01903070
• Lead Sponsor: Profil Institut für Stoffwechselforschung GmbH

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07-11
• Study First Submitted: 2013-07-11
• Study First Submitted QC: 2013-07-16
• Study First Posted: 2013-07-19
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-01
• Last Update Posted: 2017-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Linagliptin in TD2 subjects	Linagliptin	Linagliptin in TD2 subjects with normal renal function
Linagliptin in TD2 subjects with impaired renal function	Linagliptin	Linagliptin in TD2 subjects with impaired renal function

Primary Outcome Measures

Name	Time	Method
ΔAUCGLP-1-OGTT(0-240)	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.

Trial Locations

Locations (1)

Profil Institut für Stoffwechselforschung GmbH; 🇩🇪 Neuss, NRW, Germany