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Study · Randomized controlled trial · n = 1,748 · 2022

4 results

Effect of once-weekly semaglutide versus thrice-daily insulin aspart, both as add-on to metformin and optimized insulin glargine treatment in participants with type 2 diabetes (SUSTAIN 11): A randomized, open-label, multinational, phase 3b trial.

Kellerer M, Kaltoft MS, Lawson J, Nielsen LL, Strojek K, Tabak Ö, Jacob S

Diabetes, obesity & metabolism29 Jun 2022Cited by 69 (Europe PMC)

PMID35546450 (opens in a new tab)PMCIDPMC9545869 (opens in a new tab)DOI10.1111/dom.14765 (opens in a new tab)PepBankPUB-35546450
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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 study4

4 results from studies that gave the peptide. 4 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In adults with type 2 diabetes on insulin glargine and metformin, once-weekly semaglutide lowered HbA1c by 1.5% points versus 1.2% points with thrice-daily insulin aspart (non-inferior).

    In plain wordsIn adults with type 2 diabetes on basal insulin, weekly semaglutide lowered HbA1c more than mealtime insulin aspart.

    Peptide
    Semaglutide
    Outcome
    DecreaseHbA1c change from randomization to week 52
    Study

    n = 1,748

    Comparator
    Thrice-daily insulin aspart
    Analysis
    Primary
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    Dose not stated · 52 weeksAs given in this study (human).

    Measurements

    HbA1c change
    −1.5 % points
    semaglutide
    ETD vs insulin aspart
    −0.29 % points
    95% CI -0.38 to -0.20

    Source sentences

    Summary
    HbA1c (randomization: 8.6% [70.0 mmol/mol]) decreased by 1.5% points (16.6 mmol/mol) and 1.2% points (13.4 mmol/mol) with semaglutide (n = 874) and IAsp (n = 874), respectively (estimated treatment difference [ETD] -0.29% points [95% confidence interval {CI} -0.38; -0.20]; P < .0001 for non-inferiority).
    2 context sentences
    Summary · context
    To compare the efficacy and safety of once-weekly (OW) semaglutide versus thrice-daily (TID) insulin aspart (IAsp) in participants with inadequately controlled type 2 diabetes (T2D) treated with insulin glargine (IGlar) and metformin.
    Summary · context
    After a 12-week run-in to optimize once-daily IGlar U100, 1748 adults with T2D (HbA1c >7.5% to ≤10.0%) were randomized to OW semaglutide or TID IAsp as add-on to optimized IGlar and metformin for 52 weeks.
  2. 02HumanRandomized controlled trialSafety outcome

    In adults with type 2 diabetes on insulin glargine and metformin, few severe hypoglycaemic episodes occurred, with no significant difference between semaglutide and insulin aspart.

    In plain wordsIn adults with type 2 diabetes, severe low blood sugar was rare and did not differ between semaglutide and insulin aspart.

    Peptide
    Semaglutide
    Outcome
    No significant changeSevere hypoglycaemic episodes
    Study

    n = 1,748

    Comparator
    Thrice-daily insulin aspart
    Analysis
    Secondary
    Outcome group
    Adverse events · Metabolic and weight
    Studied dose
    Dose not stated · 52 weeksAs given in this study (human).

    Source sentences

    Summary
    Few severe hypoglycaemic episodes were recorded in either group, with no statistically significant difference between the groups.
    2 context sentences
    Summary · context
    To compare the efficacy and safety of once-weekly (OW) semaglutide versus thrice-daily (TID) insulin aspart (IAsp) in participants with inadequately controlled type 2 diabetes (T2D) treated with insulin glargine (IGlar) and metformin.
    Summary · context
    After a 12-week run-in to optimize once-daily IGlar U100, 1748 adults with T2D (HbA1c >7.5% to ≤10.0%) were randomized to OW semaglutide or TID IAsp as add-on to optimized IGlar and metformin for 52 weeks.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In adults with type 2 diabetes on insulin glargine and metformin, body weight changed by -4.1 kg with semaglutide versus +2.8 kg with insulin aspart.

    In plain wordsIn adults with type 2 diabetes on basal insulin, body weight fell with semaglutide and rose with insulin aspart.

    Peptide
    Semaglutide
    Outcome
    DecreaseBody weight change from randomization to week 52
    Study

    n = 1,748

    Comparator
    Thrice-daily insulin aspart
    Analysis
    Secondary
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    Dose not stated · 52 weeksAs given in this study (human).

    Measurements

    Body weight change
    −4.1 kg
    semaglutide
    ETD vs insulin aspart
    −6.99 kg
    95% CI -7.41 to -6.57

    Source sentences

    Summary
    Change in BW from randomization (87.9 kg) to week 52 was in favour of semaglutide (-4.1 kg) versus IAsp (+2.8 kg) (ETD -6.99 kg [95% CI -7.41; -6.57]).
    2 context sentences
    Summary · context
    To compare the efficacy and safety of once-weekly (OW) semaglutide versus thrice-daily (TID) insulin aspart (IAsp) in participants with inadequately controlled type 2 diabetes (T2D) treated with insulin glargine (IGlar) and metformin.
    Summary · context
    After a 12-week run-in to optimize once-daily IGlar U100, 1748 adults with T2D (HbA1c >7.5% to ≤10.0%) were randomized to OW semaglutide or TID IAsp as add-on to optimized IGlar and metformin for 52 weeks.
  4. 04HumanRandomized controlled trialSafety outcome

    In adults with type 2 diabetes on insulin glargine and metformin, a higher proportion had adverse events with semaglutide (58.5%) than with insulin aspart (52.1%), mostly mild to moderate.

    In plain wordsIn adults with type 2 diabetes on basal insulin, side effects were somewhat more common with semaglutide than with insulin aspart, mostly mild to moderate.

    Peptide
    Semaglutide
    Outcome
    IncreaseProportion with adverse events
    Study

    n = 1,748

    Comparator
    Thrice-daily insulin aspart
    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated · 52 weeksAs given in this study (human).

    Measurements

    Adverse events
    58.5%
    semaglutide

    Source sentences

    Summary
    A higher proportion of participants experienced adverse events with semaglutide (58.5%) versus IAsp (52.1%); most were mild to moderate.
    2 context sentences
    Summary · context
    To compare the efficacy and safety of once-weekly (OW) semaglutide versus thrice-daily (TID) insulin aspart (IAsp) in participants with inadequately controlled type 2 diabetes (T2D) treated with insulin glargine (IGlar) and metformin.
    Summary · context
    After a 12-week run-in to optimize once-daily IGlar U100, 1748 adults with T2D (HbA1c >7.5% to ≤10.0%) were randomized to OW semaglutide or TID IAsp as add-on to optimized IGlar and metformin for 52 weeks.

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

Registered trials1

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

1 trial · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT03689374

A Research Study to Compare Semaglutide to Insulin Aspart, When Taken Together With Metformin and Insulin Glargine, in People With Type 2 Diabetes

Novo Nordisk A/Sn = 2,2741 Oct 2018 to 22 Feb 2021

Diabetes Mellitus, Type 2

Trial pageClinicalTrials.govUpdated 14 Nov 2022

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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