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

Primary Purpose

Diabetes Mellitus

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Linagliptin
Sponsored by
Profil Institut für Stoffwechselforschung GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Profil Institut für Stoffwechselforschung GmbH

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Linagliptin in TD2 subjects

Linagliptin in TD2 subjects with impaired renal function

Arm Description

Linagliptin in TD2 subjects with normal renal function

Linagliptin in TD2 subjects with impaired renal function

Outcomes

Primary Outcome Measures

ΔAUCGLP-1-OGTT(0-240)
ΔAUCGLP-1-OGTT(0-240) Change in active GLP-1 concentrations after oral glucose ingestion after linagliptin Treatment compared between Groups.

Secondary Outcome Measures

Full Information

First Posted
July 11, 2013
Last Updated
March 1, 2017
Sponsor
Profil Institut für Stoffwechselforschung GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT01903070
Brief Title
Effects of Linagliptin on Active GLP-1 Concentrations in Subjects With Renal Impairment
Official Title
EFFECTS OF LINAGLIPTIN ON ACTIVE GLP-1 CONCENTRATIONS IN SUBJECTS WITH RENAL IMPAIRMENT
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
July 11, 2013 (Actual)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Profil Institut für Stoffwechselforschung GmbH

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
99 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Linagliptin in TD2 subjects
Arm Type
Experimental
Arm Description
Linagliptin in TD2 subjects with normal renal function
Arm Title
Linagliptin in TD2 subjects with impaired renal function
Arm Type
Experimental
Arm Description
Linagliptin in TD2 subjects with impaired renal function
Intervention Type
Drug
Intervention Name(s)
Linagliptin
Primary Outcome Measure Information:
Title
ΔAUCGLP-1-OGTT(0-240)
Description
ΔAUCGLP-1-OGTT(0-240) Change in active GLP-1 concentrations after oral glucose ingestion after linagliptin Treatment compared between Groups.
Time Frame
Glucose tolerance test following 7 days of therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christoph Kapitza, MD
Organizational Affiliation
Profil Institut für Stoffwechselforschung GmbH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Profil Institut für Stoffwechselforschung GmbH
City
Neuss
State/Province
NRW
ZIP/Postal Code
41460
Country
Germany

12. IPD Sharing Statement

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

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