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Study · Randomized controlled trial · n = 242 · 2019

6 results

Safety and Pharmacokinetics of Single and Multiple Ascending Doses of the Novel Oral Human GLP-1 Analogue, Oral Semaglutide, in Healthy Subjects and Subjects with Type 2 Diabetes.

Granhall C, Donsmark M, Blicher TM, Golor G, Søndergaard FL, Thomsen M, Bækdal TA

Clinical pharmacokinetics1 Jun 2019Cited by 130 (Europe PMC)

PMID30565096 (opens in a new tab)DOI10.1007/s40262-018-0728-4 (opens in a new tab)PepBankPUB-30565096
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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: CC BY-NC. Results still quote short attributed sentences.

Results from this study6

6 results from studies that gave the peptide. 6 results from people.

  1. 01HumanRandomized controlled trialSafety outcome

    In healthy males and males with type 2 diabetes, oral semaglutide was safe and well tolerated in two phase 1 trials.

    In plain wordsIn healthy men and men with type 2 diabetes, oral semaglutide was safe and well tolerated in two early trials.

    Peptide
    Semaglutide
    Outcome
    Not applicableOverall safety and tolerability
    Study

    n = 242

    Outcome group
    Adverse events · Pharmacology
    Studied dose
    2-20 mg single dose; 20 or 40 mg once daily · oral · single dose; 10 weeksAs given in this study (human).

    Source sentences

    Summary
    Oral semaglutide was safe and well-tolerated in both trials.
    2 context sentences
    Summary · context
    In a single-dose, first-in-human trial, 135 healthy males received oral semaglutide (2-20 mg semaglutide co-formulated with 150-600 mg SNAC) or placebo with SNAC.
    Summary · context
    In a 10-week, once-daily, multiple-dose trial, 84 healthy males received 20 or 40 mg oral semaglutide (with 300 mg SNAC), placebo, or placebo with SNAC, and 23 males with type 2 diabetes (T2D) received 40 mg oral semaglutide (with 300 mg SNAC), placebo, or placebo with SNAC.
  2. 02HumanRandomized controlled trialSafety outcome

    In healthy males and males with type 2 diabetes, most adverse events with oral semaglutide were mild, and gastrointestinal disorders were the most common.

    In plain wordsIn men given oral semaglutide, most side effects were mild, and stomach and gut problems were the most common.

    Peptide
    Semaglutide
    Outcome
    Not applicableAdverse event severity and type
    Study

    n = 242

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    2-20 mg single dose; 20 or 40 mg once daily · oral · single dose; 10 weeksAs given in this study (human).

    Source sentences

    Summary
    The majority of adverse events (AEs) were mild, with the most common AEs being gastrointestinal disorders.
    2 context sentences
    Summary · context
    In a single-dose, first-in-human trial, 135 healthy males received oral semaglutide (2-20 mg semaglutide co-formulated with 150-600 mg SNAC) or placebo with SNAC.
    Summary · context
    In a 10-week, once-daily, multiple-dose trial, 84 healthy males received 20 or 40 mg oral semaglutide (with 300 mg SNAC), placebo, or placebo with SNAC, and 23 males with type 2 diabetes (T2D) received 40 mg oral semaglutide (with 300 mg SNAC), placebo, or placebo with SNAC.
  3. 03HumanRandomized controlled trialPharmacokinetics

    In healthy males given a single dose of oral semaglutide, semaglutide exposure was highest with 300 mg of the absorption enhancer SNAC in the tablet.

    In plain wordsIn healthy men given one dose, semaglutide levels in the blood were highest when the tablet held 300 mg of the SNAC absorption aid.

    Peptide
    Semaglutide
    Outcome
    Not applicableSemaglutide exposure by SNAC dose after a single dose
    Study

    n = 135

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    2-20 mg with 150-600 mg SNAC · oral · single doseAs given in this study (human).

    Source sentences

    Summary
    In the single-dose trial, semaglutide exposure was highest when co-formulated with 300 mg SNAC.
    2 context sentences
    Summary · context
    In a single-dose, first-in-human trial, 135 healthy males received oral semaglutide (2-20 mg semaglutide co-formulated with 150-600 mg SNAC) or placebo with SNAC.
    Summary · context
    In a 10-week, once-daily, multiple-dose trial, 84 healthy males received 20 or 40 mg oral semaglutide (with 300 mg SNAC), placebo, or placebo with SNAC, and 23 males with type 2 diabetes (T2D) received 40 mg oral semaglutide (with 300 mg SNAC), placebo, or placebo with SNAC.
  4. 04HumanRandomized controlled trialPharmacokinetics

    In healthy males, semaglutide exposure was approximately twofold higher with 40 mg than with 20 mg oral semaglutide, in line with dose proportionality.

    In plain wordsIn healthy men, semaglutide blood levels were about twice as high on 40 mg as on 20 mg of the oral tablet.

    Peptide
    Semaglutide
    Outcome
    IncreaseDose proportionality of semaglutide exposure, 40 mg versus 20 mg
    Study

    n: not reported in source

    Comparator
    Oral semaglutide 20 mg
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    20 mg and 40 mg once daily · oral · 10 weeksAs given in this study (human).

    Source sentences

    Summary
    In the multiple-dose trial, semaglutide exposure was approximately twofold higher with 40 versus 20 mg oral semaglutide in healthy males, in accordance with dose proportionality
    2 context sentences
    Summary · context
    In a single-dose, first-in-human trial, 135 healthy males received oral semaglutide (2-20 mg semaglutide co-formulated with 150-600 mg SNAC) or placebo with SNAC.
    Summary · context
    In a 10-week, once-daily, multiple-dose trial, 84 healthy males received 20 or 40 mg oral semaglutide (with 300 mg SNAC), placebo, or placebo with SNAC, and 23 males with type 2 diabetes (T2D) received 40 mg oral semaglutide (with 300 mg SNAC), placebo, or placebo with SNAC.
  5. 05HumanRandomized controlled trialPharmacokinetics

    Semaglutide exposure after multiple oral doses was similar between healthy males and males with type 2 diabetes.

    In plain wordsSemaglutide blood levels after repeated oral doses were similar in healthy men and men with type 2 diabetes.

    Peptide
    Semaglutide
    Outcome
    No significant changeSemaglutide exposure in healthy males versus males with type 2 diabetes
    Study

    n: not reported in source

    Comparator
    Healthy males
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    40 mg once daily · oral · 10 weeksAs given in this study (human).

    Source sentences

    Summary
    and was similar between healthy males and males with T2D.
    2 context sentences
    Summary · context
    In a single-dose, first-in-human trial, 135 healthy males received oral semaglutide (2-20 mg semaglutide co-formulated with 150-600 mg SNAC) or placebo with SNAC.
    Summary · context
    In a 10-week, once-daily, multiple-dose trial, 84 healthy males received 20 or 40 mg oral semaglutide (with 300 mg SNAC), placebo, or placebo with SNAC, and 23 males with type 2 diabetes (T2D) received 40 mg oral semaglutide (with 300 mg SNAC), placebo, or placebo with SNAC.
  6. 06HumanRandomized controlled trialPharmacokinetics

    In healthy males and males with type 2 diabetes, the half-life of semaglutide after oral dosing was approximately 1 week in all groups.

    In plain wordsIn men given oral semaglutide, the drug stayed in the body with a half-life of about 1 week in all groups.

    Peptide
    Semaglutide
    Outcome
    Not applicableSemaglutide half-life
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    2-20 mg single dose; 20 or 40 mg once daily · oral · single dose; 10 weeksAs given in this study (human).

    Measurements

    Half-life
    ≈ 1 week
    all groups

    Source sentences

    Summary
    The half-life of semaglutide was approximately 1 week in all groups.
    2 context sentences
    Summary · context
    In a single-dose, first-in-human trial, 135 healthy males received oral semaglutide (2-20 mg semaglutide co-formulated with 150-600 mg SNAC) or placebo with SNAC.
    Summary · context
    In a 10-week, once-daily, multiple-dose trial, 84 healthy males received 20 or 40 mg oral semaglutide (with 300 mg SNAC), placebo, or placebo with SNAC, and 23 males with type 2 diabetes (T2D) received 40 mg oral semaglutide (with 300 mg SNAC), placebo, or placebo with SNAC.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials2

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

2 trials · 2 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 1NCT01686945

Investigation on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of a Long-acting GLP-1 Analogue in Healthy Male Subjects and Male Subjects With Type 2 Diabetes

Novo Nordisk A/Sn = 10719 Sept 2012 to 8 Apr 2013

Diabetes · Diabetes Mellitus, Type 2 · Healthy

Trial pageClinicalTrials.govUpdated 4 Jan 2019
CompletedPhase 1NCT01037582

A Two Part Trial Investigating the Safety of NN9924 in Healthy Male Subjects

Novo Nordisk A/Sn = 15517 Dec 2009 to 7 May 2010

Diabetes · Diabetes Mellitus, Type 2 · Healthy

Trial pageClinicalTrials.govUpdated 3 Jan 2019

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    11 Oct 2026, 00:50 UTC

    Study results updated

  2. Version 1

    9 Oct 2026, 03:06 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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