Semaglutide induces weight loss in subjects with type 2 diabetes regardless of baseline BMI or gastrointestinal adverse events in the SUSTAIN 1 to 5 trials.

Ahrén B, Atkin SL, Charpentier G, Warren ML, Wilding JPH, Birch S, Holst AG, Leiter LA

Diabetes, obesity & metabolism12 Jun 2018Cited by 122 (Europe PMC)

PMID29766634PMCIDPMC6099440DOI10.1111/dom.13353PepBankPUB-29766634

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Summary

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

Results from this study5

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

01HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, clinically relevant weight-loss differences with semaglutide versus comparators were seen across all baseline BMI subgroups.
In plain wordsIn adults with type 2 diabetes, semaglutide led to meaningful weight loss compared with other treatments at every starting body mass index.
Peptide
Semaglutide
Outcome
DecreaseWeight loss across baseline BMI subgroups
Study
n: not reported in source
Comparator
Comparators (placebo, sitagliptin, exenatide ER, insulin glargine)
Outcome group
Body weight · Metabolic and weight
Studied dose
0.5 or 1.0 mg · subcutaneousAs given in this study (human).
Source sentences
Summary
Clinically relevant weight-loss differences were observed across all BMI subgroups
1 context sentence(design, population, supporting numbers)
Summary · context
Subjects with inadequately controlled type 2 diabetes (drug-naïve or on background treatment) were randomized to subcutaneous semaglutide 0.5 mg (excluding SUSTAIN 3), 1.0 mg (all trials), or comparator (placebo, sitagliptin, exenatide extended release or insulin glargine).
Report a problemFND-2976663401
02HumanRandomized controlled trialEfficacy outcome
There was a trend towards higher absolute weight loss with semaglutide at higher baseline BMI.
In plain wordsAdults with a higher starting body mass index tended to lose more weight with semaglutide.
Peptide
Semaglutide
Outcome
Not applicableAbsolute weight loss by baseline BMI (trend)
Study
n: not reported in source
Outcome group
Body weight · Metabolic and weight
Studied dose
0.5 or 1.0 mg · subcutaneousAs given in this study (human).
Source sentences
Summary
with a trend towards higher absolute weight loss with higher baseline BMI.
1 context sentence(design, population, supporting numbers)
Summary · context
Subjects with inadequately controlled type 2 diabetes (drug-naïve or on background treatment) were randomized to subcutaneous semaglutide 0.5 mg (excluding SUSTAIN 3), 1.0 mg (all trials), or comparator (placebo, sitagliptin, exenatide extended release or insulin glargine).
Report a problemFND-2976663402
03HumanRandomized controlled trialSafety outcome
Nausea or vomiting occurred in a higher proportion of patients on semaglutide 0.5 mg than on comparators.
In plain wordsMore patients on semaglutide 0.5 mg had nausea or vomiting than on comparator treatments.
Peptide
Semaglutide
Outcome
IncreaseNausea or vomiting
Study
n: not reported in source
Comparator
Comparators (placebo, sitagliptin, exenatide ER, insulin glargine)
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
0.5 mg · subcutaneousAs given in this study (human).
Measurements
Nausea or vomiting
15.2 to 24%
semaglutide 0.5 mg
Nausea or vomiting
6 to 14.1%
comparators
Source sentences
Summary
Overall, 15.2% to 24.0% and 21.5% to 27.2% of subjects experienced nausea or vomiting with semaglutide 0.5 and 1.0 mg, respectively, versus 6.0% to 14.1% with comparators.
1 context sentence(design, population, supporting numbers)
Summary · context
Subjects with inadequately controlled type 2 diabetes (drug-naïve or on background treatment) were randomized to subcutaneous semaglutide 0.5 mg (excluding SUSTAIN 3), 1.0 mg (all trials), or comparator (placebo, sitagliptin, exenatide extended release or insulin glargine).
Report a problemFND-2976663403
04HumanRandomized controlled trialSafety outcome
Nausea or vomiting occurred in a higher proportion of patients on semaglutide 1.0 mg than on comparators.
In plain wordsMore patients on semaglutide 1.0 mg had nausea or vomiting than on comparator treatments.
Peptide
Semaglutide
Outcome
IncreaseNausea or vomiting
Study
n: not reported in source
Comparator
Comparators (placebo, sitagliptin, exenatide ER, insulin glargine)
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
1.0 mg · subcutaneousAs given in this study (human).
Measurements
Nausea or vomiting
21.5 to 27.2%
semaglutide 1.0 mg
Nausea or vomiting
6 to 14.1%
comparators
Source sentences
Summary
Overall, 15.2% to 24.0% and 21.5% to 27.2% of subjects experienced nausea or vomiting with semaglutide 0.5 and 1.0 mg, respectively, versus 6.0% to 14.1% with comparators.
1 context sentence(design, population, supporting numbers)
Summary · context
Subjects with inadequately controlled type 2 diabetes (drug-naïve or on background treatment) were randomized to subcutaneous semaglutide 0.5 mg (excluding SUSTAIN 3), 1.0 mg (all trials), or comparator (placebo, sitagliptin, exenatide extended release or insulin glargine).
Report a problemFND-2976663404
05HumanRandomized controlled trialMechanism
Nausea or vomiting mediated only a small part of the weight difference between semaglutide and comparators.
In plain wordsNausea or vomiting explained only a small part of the extra weight loss with semaglutide compared with other treatments.
Peptide
Semaglutide
Outcome
Not applicableShare of weight loss mediated by nausea or vomiting
Study
n: not reported in source
Comparator
Comparators (placebo, sitagliptin, exenatide ER, insulin glargine)
Outcome group
Body weight · Metabolic and weight
Studied dose
0.5 or 1.0 mg · subcutaneousAs given in this study (human).
Measurements
Weight difference mediated by nausea or vomiting
0.07 to 0.5 kg
indirect effect
Source sentences
Summary
Only 0.07 to 0.5 kg of the treatment difference between semaglutide and comparators was mediated by nausea or vomiting (indirect effects).
1 context sentence(design, population, supporting numbers)
Summary · context
Subjects with inadequately controlled type 2 diabetes (drug-naïve or on background treatment) were randomized to subcutaneous semaglutide 0.5 mg (excluding SUSTAIN 3), 1.0 mg (all trials), or comparator (placebo, sitagliptin, exenatide extended release or insulin glargine).
Report a problemFND-2976663405

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Registered trials5

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

5 trials · 5 completed · 5 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT02305381