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Study · Randomized controlled trial · n = 114 · 2020

5 results

Effects of once-weekly semaglutide vs once-daily canagliflozin on body composition in type 2 diabetes: a substudy of the SUSTAIN 8 randomised controlled clinical trial.

McCrimmon RJ, Catarig AM, Frias JP, Lausvig NL, le Roux CW, Thielke D, Lingvay I

Diabetologia2 Jan 2020Cited by 153 (Europe PMC)

PMID31897524 (opens in a new tab)PMCIDPMC6997246 (opens in a new tab)DOI10.1007/s00125-019-05065-8 (opens in a new tab)PepBankPUB-31897524
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Summary

Aims/hypothesisIntra-abdominal or visceral obesity is associated with insulin resistance and an increased risk for cardiovascular disease. This study aimed to compare the effects of semaglutide 1.0 mg and canagliflozin 300 mg on body composition in a subset of participants from the SUSTAIN 8 Phase IIIB, randomised double-blind trial who underwent whole-body dual-energy x-ray absorptiometry (DXA) scanning.MethodsAdults (age ≥18 years) with type 2 diabetes, HbA1c 53-91 mmol/mol (7.0-10.5%), on a stable daily dose of metformin (≥1500 mg or maximum tolerated dose) and with an eGFR ≥60 ml min-1 [1.73 m]-2 were randomised 1:1 to semaglutide 1.0 mg once weekly and canagliflozin placebo once daily, or canagliflozin 300 mg once daily and semaglutide placebo once weekly. Body composition was assessed using whole-body DXA scans. The study participants and investigator remained blinded throughout the trial, and quality of DXA scans was evaluated in a blinded manner. Change from baseline to week 52 in total fat mass (kg) was the confirmatory efficacy endpoint.ResultsA subset of 178 participants (semaglutide, n = 88; canagliflozin, n = 90) underwent DXA scanning at screening and were randomised into the substudy. Of these, 114 (semaglutide, n = 53; canagliflozin, n = 61) participants had observed end-of-treatment data included in the confirmatory efficacy analysis. Of the 178 participants in the substudy, numerical improvements in body composition (including fat mass, lean mass and visceral fat mass) were observed after 52 weeks with both treatments. Total fat mass (baseline 33.2 kg) was reduced by 3.4 kg and 2.6 kg with semaglutide and canagliflozin, respectively (estimated treatment difference: -0.79 [95% CI -2.10, 0.51]). Although total lean mass (baseline 51.3 kg) was also reduced by 2.3 kg and 1.5 kg with semaglutide and canagliflozin, respectively (estimated treatment difference: -0.78 [-1.61, 0.04]), the proportion of lean mass (baseline 59.4%) increased by 1.2%- and 1.1%-point, respectively (estimated treatment difference 0.14 [-0.89, 1.17]). Changes in visceral fat mass and overall changes in body composition (assessed by the fat to lean mass ratio) were comparable between the two treatment groups.Conclusions/interpretationIn individuals with uncontrolled type 2 diabetes on stable-dose metformin therapy, the changes in body composition with semaglutide and canagliflozin were not significantly different. Although numerical improvements in body composition were observed following treatment in both treatment arms, the specific impact of both treatments on body composition in the absence of a placebo arm is speculative at this stage.Trial registrationClinicalTrials.gov NCT03136484.FundingThis trial was supported by Novo Nordisk A/S, Denmark.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study5

5 results from studies that gave the peptide. 5 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In adults with type 2 diabetes on metformin, total fat mass fell with semaglutide and canagliflozin, with no significant difference between them at week 52.

    In plain wordsIn adults with type 2 diabetes, semaglutide and canagliflozin lowered total fat mass by similar amounts.

    Peptide
    Semaglutide
    Outcome
    No significant changeTotal fat mass, change from baseline to week 52
    Study

    n = 114

    Comparator
    Canagliflozin 300 mg
    Outcome group
    Body composition · Metabolic and weight
    Studied dose
    1.0 mg once weekly · 52 weeksAs given in this study (human).

    Measurements

    Total fat mass reduction
    3.4 kg
    semaglutide
    Estimated treatment difference
    −0.79 kg
    versus canagliflozin

    Source sentences

    Summary
    Total fat mass (baseline 33.2 kg) was reduced by 3.4 kg and 2.6 kg with semaglutide and canagliflozin, respectively (estimated treatment difference: -0.79 [95% CI -2.10, 0.51]).
    2 context sentences
    Summary · context
    Of these, 114 (semaglutide, n = 53; canagliflozin, n = 61) participants had observed end-of-treatment data included in the confirmatory efficacy analysis.
    Summary · context
    Adults (age ≥18 years) with type 2 diabetes, HbA1c 53-91 mmol/mol (7.0-10.5%), on a stable daily dose of metformin (≥1500 mg or maximum tolerated dose) and with an eGFR ≥60 ml min-1 [1.73 m]-2 were randomised 1:1 to semaglutide 1.0 mg once weekly and canagliflozin placebo once daily, or canagliflozin 300 mg once daily and semaglutide placebo once weekly.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In adults with type 2 diabetes on metformin, total lean mass was reduced with semaglutide and canagliflozin, with no significant difference between them.

    In plain wordsIn adults with type 2 diabetes, semaglutide and canagliflozin lowered lean mass by similar amounts.

    Peptide
    Semaglutide
    Outcome
    No significant changeTotal lean mass, change from baseline to week 52
    Study

    n: not reported in source

    Comparator
    Canagliflozin 300 mg
    Outcome group
    Body composition · Metabolic and weight
    Studied dose
    1.0 mg once weekly · 52 weeksAs given in this study (human).

    Measurements

    Total lean mass reduction
    2.3 kg
    semaglutide
    Estimated treatment difference
    −0.78 kg
    versus canagliflozin

    Source sentences

    Summary
    total lean mass (baseline 51.3 kg) was also reduced by 2.3 kg and 1.5 kg with semaglutide and canagliflozin, respectively (estimated treatment difference: -0.78 [-1.61, 0.04])
    1 context sentence
    Summary · context
    Adults (age ≥18 years) with type 2 diabetes, HbA1c 53-91 mmol/mol (7.0-10.5%), on a stable daily dose of metformin (≥1500 mg or maximum tolerated dose) and with an eGFR ≥60 ml min-1 [1.73 m]-2 were randomised 1:1 to semaglutide 1.0 mg once weekly and canagliflozin placebo once daily, or canagliflozin 300 mg once daily and semaglutide placebo once weekly.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In adults with type 2 diabetes on metformin, the proportion of lean mass increased with semaglutide and canagliflozin, with no significant difference between them.

    In plain wordsIn adults with type 2 diabetes, the share of lean mass rose with semaglutide and canagliflozin by similar amounts.

    Peptide
    Semaglutide
    Outcome
    No significant changeProportion of lean mass, change from baseline to week 52
    Study

    n: not reported in source

    Comparator
    Canagliflozin 300 mg
    Outcome group
    Body composition · Metabolic and weight
    Studied dose
    1.0 mg once weekly · 52 weeksAs given in this study (human).

    Measurements

    Proportion of lean mass increase
    1.2 %-point
    semaglutide
    Estimated treatment difference
    0.14 %-point
    versus canagliflozin

    Source sentences

    Summary
    the proportion of lean mass (baseline 59.4%) increased by 1.2%- and 1.1%-point, respectively (estimated treatment difference 0.14 [-0.89, 1.17])
    1 context sentence
    Summary · context
    Adults (age ≥18 years) with type 2 diabetes, HbA1c 53-91 mmol/mol (7.0-10.5%), on a stable daily dose of metformin (≥1500 mg or maximum tolerated dose) and with an eGFR ≥60 ml min-1 [1.73 m]-2 were randomised 1:1 to semaglutide 1.0 mg once weekly and canagliflozin placebo once daily, or canagliflozin 300 mg once daily and semaglutide placebo once weekly.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In adults with type 2 diabetes on metformin, changes in visceral fat mass were comparable between semaglutide and canagliflozin.

    In plain wordsIn adults with type 2 diabetes, visceral fat changed by similar amounts with semaglutide and canagliflozin.

    Peptide
    Semaglutide
    Outcome
    No significant changeVisceral fat mass
    Study

    n: not reported in source

    Comparator
    Canagliflozin 300 mg
    Outcome group
    Body composition · Metabolic and weight
    Studied dose
    1.0 mg once weekly · 52 weeksAs given in this study (human).

    Source sentences

    Summary
    Changes in visceral fat mass and overall changes in body composition (assessed by the fat to lean mass ratio) were comparable between the two treatment groups.
    1 context sentence
    Summary · context
    Adults (age ≥18 years) with type 2 diabetes, HbA1c 53-91 mmol/mol (7.0-10.5%), on a stable daily dose of metformin (≥1500 mg or maximum tolerated dose) and with an eGFR ≥60 ml min-1 [1.73 m]-2 were randomised 1:1 to semaglutide 1.0 mg once weekly and canagliflozin placebo once daily, or canagliflozin 300 mg once daily and semaglutide placebo once weekly.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In adults with type 2 diabetes on metformin, overall changes in body composition by fat to lean mass ratio were comparable between semaglutide and canagliflozin.

    In plain wordsIn adults with type 2 diabetes, the fat to lean mass ratio changed by similar amounts with semaglutide and canagliflozin.

    Peptide
    Semaglutide
    Outcome
    No significant changeFat to lean mass ratio
    Study

    n: not reported in source

    Comparator
    Canagliflozin 300 mg
    Outcome group
    Body composition · Metabolic and weight
    Studied dose
    1.0 mg once weekly · 52 weeksAs given in this study (human).

    Source sentences

    Summary
    Changes in visceral fat mass and overall changes in body composition (assessed by the fat to lean mass ratio) were comparable between the two treatment groups.
    1 context sentence
    Summary · context
    Adults (age ≥18 years) with type 2 diabetes, HbA1c 53-91 mmol/mol (7.0-10.5%), on a stable daily dose of metformin (≥1500 mg or maximum tolerated dose) and with an eGFR ≥60 ml min-1 [1.73 m]-2 were randomised 1:1 to semaglutide 1.0 mg once weekly and canagliflozin placebo once daily, or canagliflozin 300 mg once daily and semaglutide placebo once weekly.

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

RecruitingPhase not statedNCT07835360

Body Composition Changes After Initiation of GLP-1 Receptor Agonists in Adults With Obesity or Type 2 Diabetes

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubirann = 20010 Jul 2026 to est. Jul 2029

Obesity (Disorder) · Type 2 Diabetes Mellitus

Trial pageClinicalTrials.govUpdated 25 Sept 2026
CompletedPhase 3Results postedNCT03136484

Efficacy and Safety of Semaglutide Versus Canagliflozin as add-on to Metformin in Subjects With Type 2 Diabetes

Novo Nordisk A/Sn = 78815 Mar 2017 to 16 Nov 2018

Diabetes · Diabetes Mellitus, Type 2

Trial pageClinicalTrials.govUpdated 21 Jan 2020

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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