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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01903070
Recruitment Status : Completed
First Posted : July 19, 2013
Last Update Posted : March 3, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Drug: Linagliptin Phase 4

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Study Type : Interventional  (Clinical Trial)
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 : July 11, 2013
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Linagliptin

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



Primary Outcome Measures :
  1. ΔAUCGLP-1-OGTT(0-240) [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01903070


Locations
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Germany
Profil Institut für Stoffwechselforschung GmbH
Neuss, NRW, Germany, 41460
Sponsors and Collaborators
Profil Institut für Stoffwechselforschung GmbH
Investigators
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Principal Investigator: Christoph Kapitza, MD Profil Institut für Stoffwechselforschung GmbH

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Responsible Party: Profil Institut für Stoffwechselforschung GmbH
ClinicalTrials.gov Identifier: NCT01903070     History of Changes
Other Study ID Numbers: 00/0594-LINARI
First Posted: July 19, 2013    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
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Diabetes Mellitus
Renal Insufficiency
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Kidney Diseases
Urologic Diseases
Linagliptin
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action