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The main objective of this study was to assess the effect of normal and impaired renal function on the safety, pharmacokinetics, and pharmacodynamics of linagliptin following oral administration of 5 mg daily for 7 days (Groups 1 to 3), 5 mg daily for 10 days (Groups 6 and 7), or as a single dose (Groups 4 and 5)
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Inclusion criteria
Male or female subjects with normal renal function, defined as a Creatinine Clearance (CrCl) of >80 mL/min on screening (Group 1) , or male or female patients with Type 2 diabetes mellitus (T2DM) and normal renal function, defined as a CrCl of >80 mL/min on screening (Group 7)
Male or female patients with Renal impairment (RI), determined by the value of CrCl on Screening estimated according to the Cockcroft-Gault formula. Patients were classified into groups by their CrCl values:
Age 18 to 80 years
BMI 18 to 40 kg/m2, and minimum body mass of at least 45 kg for females
Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation
Exclusion criteria
Participants (with or without RI) who met any of the following criteria were not included in this trial:
For female patients
Subjects with normal renal function (Group 1) and subjects with T2DM and normal renal function (Group 7) who met the following criterium were not included in this trial:
Patients with RI who met any of the following criteria were not included in this trial:
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51 participants in 7 patient groups
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Data sourced from clinicaltrials.gov
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