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

EFFECTS OF LINAGLIPTIN ON ACTIVE GLP-1 CONCENTRATIONS IN SUBJECTS WITH RENAL IMPAIRMENT

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01903070
Enrollment
99
Registered
2013-07-19
Start date
2013-07-11
Completion date
2016-04-30
Last updated
2017-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

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.

Interventions

DRUGLinagliptin

Sponsors

Profil Institut für Stoffwechselforschung GmbH
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
ΔAUCGLP-1-OGTT(0-240)Glucose tolerance test following 7 days of therapyΔAUCGLP-1-OGTT(0-240) Change in active GLP-1 concentrations after oral glucose ingestion after linagliptin Treatment compared between Groups.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026