| Title |
A Randomized Trial Investigating the Pharmacokinetics, Pharmacodynamics, and Safety of Subcutaneous Semaglutide Once-Weekly in Healthy Male Japanese and Caucasian Subjects
|
|---|---|
| Published in |
Advances in Therapy, March 2018
|
| DOI | 10.1007/s12325-018-0677-1 |
| Pubmed ID | |
| Authors |
Ippei Ikushima, Lene Jensen, Anne Flint, Tomoyuki Nishida, Jeppe Zacho, Shin Irie |
| Abstract |
Semaglutide is a glucagon-like peptide-1 analogue for once-weekly subcutaneous treatment of type 2 diabetes. This trial compared the pharmacokinetics, pharmacodynamics, and safety of semaglutide in Japanese and Caucasian subjects. In this single-center, double-blind, parallel-group, 13-week trial, 44 healthy male subjects (22 Japanese, 22 Caucasian) were randomized within each race to semaglutide 0.5 mg (n = 8), 1.0 mg (n = 8), placebo 0.5 mg (n = 3) or 1.0 mg (n = 3). The primary endpoint was semaglutide exposure at steady state [area under the curve (AUC0-168h)]. Steady-state exposure of semaglutide was similar for both populations: AUC0-168h estimated race ratio (ERR), Japanese/Caucasian: 0.5 mg, 1.06; 1.0 mg, 0.99; maximum concentration (Cmax) ERR: 0.5 mg, 1.06; 1.0 mg, 1.02. Exposure after the first dose (0.25 mg) was slightly higher in Japanese versus Caucasian subjects (AUC0-168h ERR 1.11; Cmax ERR 1.14). Dose-dependent increases in AUC0-168h and Cmax occurred in both populations. Accumulation was as expected, based on the half-life (t1/2, ~ 1 week) and dosing interval of semaglutide. Significant body weight reductions were observed with semaglutide 0.5 mg and 1.0 mg in Japanese (both p ≤ 0.05) and Caucasian (both p ≤ 0.05) subjects versus placebo. No new safety issues were identified. The pharmacokinetic, pharmacodynamic, and safety profiles of semaglutide were similar in Japanese and Caucasian subjects, suggesting that no dose adjustment is required for the clinical use of semaglutide in Japanese subjects. Novo Nordisk A/S, Denmark. ClinicalTrials.gov identifier NCT02146079. Japanese trial registration number JapicCTI-142550. |
X Demographics
The data shown below were collected from the profiles of 2 X users who shared this research output. Click here to find out more about how the information was compiled.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| United States | 1 | 50% |
| Unknown | 1 | 50% |
Demographic breakdown
| Type | Count | As % |
|---|---|---|
| Practitioners (doctors, other healthcare professionals) | 1 | 50% |
| Science communicators (journalists, bloggers, editors) | 1 | 50% |
Mendeley readers
The data shown below were compiled from readership statistics for 74 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 74 | 100% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Student > Bachelor | 11 | 15% |
| Student > Master | 9 | 12% |
| Student > Ph. D. Student | 7 | 9% |
| Other | 5 | 7% |
| Researcher | 4 | 5% |
| Other | 7 | 9% |
| Unknown | 31 | 42% |
| Readers by discipline | Count | As % |
|---|---|---|
| Medicine and Dentistry | 19 | 26% |
| Nursing and Health Professions | 8 | 11% |
| Biochemistry, Genetics and Molecular Biology | 5 | 7% |
| Pharmacology, Toxicology and Pharmaceutical Science | 3 | 4% |
| Chemistry | 2 | 3% |
| Other | 6 | 8% |
| Unknown | 31 | 42% |
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 09 December 2022.
All research outputs
#15,153,715
of 23,306,612 outputs
Outputs from Advances in Therapy
#1,271
of 2,394 outputs
Outputs of similar age
#202,997
of 334,303 outputs
Outputs of similar age from Advances in Therapy
#22
of 34 outputs
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