| Title |
Pharmacokinetics, Safety and Tolerability of Oral Semaglutide in Subjects with Renal Impairment
|
|---|---|
| Published in |
Clinical Pharmacokinetics, April 2018
|
| DOI | 10.1007/s40262-018-0649-2 |
| Pubmed ID | |
| Authors |
Charlotte Granhall, Flemming L. Søndergaard, Mette Thomsen, Thomas W. Anderson |
| Abstract |
Semaglutide, a glucagon-like peptide-1 (GLP-1) analogue, has been co-formulated with the absorption enhancer sodium N-(8-[2-hydroxybenzoyl] amino) caprylate (SNAC) as a tablet for oral administration. This trial (NCT02014259) investigated the pharmacokinetics, safety and tolerability of oral semaglutide in subjects with and without renal impairment. Subjects were categorised as having normal renal function (n = 24), mild (n = 12), moderate (n = 12) or severe (n = 12) renal impairment, or end-stage renal disease (ESRD) requiring haemodialysis (n = 11) and received once-daily oral semaglutide (5 mg for 5 days followed by 10 mg for 5 days) in the fasting state, followed by 30 min fasting after dosing. Semaglutide plasma concentrations were measured during dosing and for up to 21 days after the last dose. Semaglutide exposure (area under the plasma concentration-time curve from time zero to 24 h after the tenth dose and maximum concentration after the tenth dose) did not vary in a consistent pattern across the renal function groups. Similarly, there was no apparent effect of renal impairment on the semaglutide half-life (geometric mean range 152-165 h). Except for one subject in the ESRD group, semaglutide was not detected in urine. Haemodialysis did not affect the pharmacokinetics of semaglutide. Adverse events were in line with those observed for other GLP-1 receptor agonists and no safety concerns were identified. There was no apparent effect of renal impairment or haemodialysis on the pharmacokinetics of oral semaglutide. Based on this trial, renal impairment should not affect dose recommendations for oral semaglutide. |
X Demographics
The data shown below were collected from the profiles of 4 X users who shared this research output. Click here to find out more about how the information was compiled.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Spain | 2 | 50% |
| Saudi Arabia | 1 | 25% |
| Unknown | 1 | 25% |
Demographic breakdown
| Type | Count | As % |
|---|---|---|
| Members of the public | 3 | 75% |
| Practitioners (doctors, other healthcare professionals) | 1 | 25% |
Mendeley readers
The data shown below were compiled from readership statistics for 96 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 96 | 100% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Student > Master | 13 | 14% |
| Student > Ph. D. Student | 10 | 10% |
| Student > Postgraduate | 9 | 9% |
| Student > Bachelor | 8 | 8% |
| Researcher | 8 | 8% |
| Other | 15 | 16% |
| Unknown | 33 | 34% |
| Readers by discipline | Count | As % |
|---|---|---|
| Medicine and Dentistry | 30 | 31% |
| Pharmacology, Toxicology and Pharmaceutical Science | 12 | 13% |
| Biochemistry, Genetics and Molecular Biology | 4 | 4% |
| Nursing and Health Professions | 3 | 3% |
| Agricultural and Biological Sciences | 2 | 2% |
| Other | 8 | 8% |
| Unknown | 37 | 39% |
Attention Score in Context
This research output has an Altmetric Attention Score of 2. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 12 February 2021.
All research outputs
#14,505,038
of 24,337,175 outputs
Outputs from Clinical Pharmacokinetics
#1,165
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#174,972
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Outputs of similar age from Clinical Pharmacokinetics
#17
of 27 outputs
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