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

• Sponsor: Profil Institut für Stoffwechselforschung GmbH (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01903070
• Collaborator: (none)
• Enrollment: 99
• Location: 1
• Arms: 2
• Actual Duration (Months): 32.7
• Patients Per Site Per Month: 3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus	Drug: Linagliptin	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 99 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: EFFECTS OF LINAGLIPTIN ON ACTIVE GLP-1 CONCENTRATIONS IN SUBJECTS WITH RENAL IMPAIRMENT
• Actual Study Start Date: Jul 11, 2013
• Actual Primary Completion Date: Apr 1, 2016
• Actual Study Completion Date: Apr 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Linagliptin in TD2 subjects Linagliptin in TD2 subjects with normal renal function	Drug: Linagliptin
Experimental: Linagliptin in TD2 subjects with impaired renal function Linagliptin in TD2 subjects with impaired renal function	Drug: Linagliptin

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Profil Institut für Stoffwechselforschung GmbH	Neuss	NRW	Germany	41460

Sponsors and Collaborators

• Profil Institut für Stoffwechselforschung GmbH

Investigators

• Principal Investigator: Christoph Kapitza, MD, Profil Institut für Stoffwechselforschung GmbH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Profil Institut für Stoffwechselforschung GmbH
• ClinicalTrials.gov Identifier: NCT01903070
• Other Study ID Numbers: 00/0594-LINARI
• First Posted: Jul 19, 2013
• Last Update Posted: Mar 3, 2017
• Last Verified: Mar 1, 2017

• Additional relevant MeSH terms: Renal Insufficiency; Linagliptin

Study Results

No Results Posted as of Mar 3, 2017