Evidence mapPaperPMID 29907893Full record

ArticleDiabetes therapy : research, treatment and education of diabetes and related disorders2018

Semaglutide s.c. Once-Weekly in Type 2 Diabetes: A Population Pharmacokinetic Analysis.

Kristin Cecilie Carlsson Petri, Steen Hvass Ingwersen, Anne Flint, Jeppe Zacho, Rune Viig Overgaard

5 registry-linked trialsAbstract read
In one paragraph

Article in Diabetes therapy : research, treatment and education of diabetes and related disorders, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT01720446. Cited by 31 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 4 pooled it
field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01720446 phase3completed

A Long-term, Randomised, Double-blind, Placebo-controlled, Multinational, Multi-centre Trial to Evaluate Cardiovascular and Other Long-term Outcomes With Semaglutide in Subjects With Type 2 Diabetes (SUSTAIN™ 6 - Long-term Outcomes)

Ran2013Enrolled3,297Registered outcomes16Posted comparisons54ConditionsDiabetes, Diabetes Mellitus, Type 2ArmsPlacebo, semaglutide
Open the trial in the graph
NCT01885208 phase3completed

Efficacy and Safety of Semaglutide Once-weekly Versus Exenatide ER 2.0 mg Once-weekly as add-on to 1-2 Oral Antidiabetic Drugs (OADs) in Subjects With Type 2 Diabetes (SUSTAIN™ 3 - vs. QW GLP-1)

Ran2013Enrolled813Registered outcomes6Posted comparisons2ConditionsDiabetes, Diabetes Mellitus, Type 2Armsexenatide, semaglutide
Open the trial in the graph
NCT01930188 phase3completed

Efficacy and Safety of Semaglutide Once-weekly Versus Sitagliptin Once-daily as add-on to Metformin and/or TZD in Subjects With Type 2 Diabetes (SUSTAIN™ 2 - vs. DPP-4 Inhibitor)

Ran2013Enrolled1,231Registered outcomes6Posted comparisons2ConditionsDiabetes, Diabetes Mellitus, Type 2ArmsPlacebo, semaglutide, Sitagliptin
Open the trial in the graph
NCT02054897 phase3completed

Efficacy and Safety of Semaglutide Once-weekly Versus Placebo in Drug-naïve Subjects With Type 2 Diabetes

Ran2014Enrolled388Registered outcomes6Posted comparisons2ConditionsDiabetes, Diabetes Mellitus, Type 2ArmsPlacebo, semaglutide
Open the trial in the graph
NCT02207374 phase3completed

Safety and Efficacy of Semaglutide Once Weekly in Monotherapy or in Combination With One OAD in Japanese Subjects With Type 2 Diabetes Who Are Insufficiently Controlled on Diet/Exercise Therapy or OAD Monotherapy

Ran2014Enrolled601Registered outcomes3Posted comparisons0ConditionsDiabetes, Diabetes Mellitus, Type 2ArmsDPP-4 inhibitor, semaglutide
PMID 29748996PMID 29322610other papers from this trial
Open the trial in the graph
3 · Its place in the literature

Who cites it

31 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. Pooled it
  2. Clinical Pharmacokinetics of Semaglutide: A Systematic Review.Drug design, development and therapy · 2024
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Kristin Cecilie Carlsson PetriNovo Nordisk A/S, Vandtårnsvej 108, 2860, Søborg, Denmark. KCC@NovoNordisk.com.
Steen Hvass IngwersenNovo Nordisk A/S, Vandtårnsvej 108, 2860, Søborg, Denmark.
Anne FlintNovo Nordisk A/S, Vandtårnsvej 108, 2860, Søborg, Denmark.
Jeppe ZachoNovo Nordisk A/S, Vandtårnsvej 108, 2860, Søborg, Denmark.
Rune Viig OvergaardNovo Nordisk A/S, Vandtårnsvej 108, 2860, Søborg, Denmark.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionSemaglutide, a new treatment option approved for the treatment of patients with type 2 diabetes mellitus, is a glucagon-like peptide-1 receptor agonist to be injected subcutaneously once weekly. This analysis used a population pharmacokinetic model of semaglutide to identify clinically relevant covariates for exposure.

methodsA total of 1612 patients with up to seven pharmacokinetic observations each were included in the analysis. All subjects had type 2 diabetes mellitus and were enrolled in one of five trials in the phase III development program for subcutaneous semaglutide once weekly (the SUSTAIN program). The treatment duration of the trials varied from 30 to 104 weeks.

resultsNo clinically relevant effects on the exposure were seen for sex, age, race, ethnicity, renal function, or injection site used, and semaglutide exposure was stable over time. Of the covariates chosen, only body weight had a relevant effect on the exposure of semaglutide. Few subjects developed semaglutide antibodies, and the antibodies had no effect on exposure. Dose proportionality was shown for the 0.5 mg and 1.0 mg maintenance doses of semaglutide.

conclusionThe population pharmacokinetic study showed that semaglutide exposure is not affected by covariates other than body weight at either a maintenance dose of 0.5 or 1.0 mg semaglutide. Therefore, we conclude that no semaglutide dose adjustments are needed in different populations. This finding is to be further explored in an exposure-response analysis.

trial registrationThe trials were registered at ClinicalTrials.gov (identifiers: NCT02054897, NCT01930188, NCT01885208, NCT01720446 and NCT02207374).

fundingNovo Nordisk A/S, Bagsværd, Denmark.

Indexed as

GLP-1 analogGLP-1 receptor agonistPopulation pharmacokineticsSemaglutide

Identifiers

PMID29907893
PMCPMC6064581

What Socratic holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.