Effect of Additional Oral Semaglutide vs Sitagliptin on Glycated Hemoglobin in Adults With Type 2 Diabetes Uncontrolled With Metformin Alone or With Sulfonylurea: The PIONEER 3 Randomized Clinical Trial.

Rosenstock J, Allison D, Birkenfeld AL, Blicher TM, Deenadayalan S, Jacobsen JB, Serusclat P, Violante R, Watada H, Davies M

JAMA1 Apr 2019Cited by 331 (Europe PMC)

PMID30903796PMCIDPMC6484814DOI10.1001/jama.2019.2942PepBankPUB-30903796

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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: Publisher copyright. Results still quote short attributed sentences.

Results from this study10

10 results from studies that gave the peptide. 10 results from people.

01HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes uncontrolled on metformin, oral semaglutide 7 mg/d reduced HbA1c more than sitagliptin at week 26.
In plain wordsIn adults with type 2 diabetes, oral semaglutide 7 mg lowered HbA1c more than sitagliptin after 26 weeks.
Peptide
Semaglutide
Outcome
DecreaseHbA1c change at week 26
Study
n: not reported in source
Comparator
Sitagliptin 100 mg
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
7 mg/d · oral · 26 weeksAs given in this study (human).
Measurements
HbA1c difference vs sitagliptin
−0.3%
semaglutide 7 mg/d, week 26
Source sentences
Summary
Semaglutide, 7 and 14 mg/d, compared with sitagliptin, significantly reduced HbA1c (differences, -0.3% [95% CI, -0.4% to -0.1%] and -0.5% [95% CI, -0.6% to -0.4%]
2 context sentences(design, population, supporting numbers)
Summary · context
Of 2463 patients screened, 1864 adults with type 2 diabetes uncontrolled with metformin with or without sulfonylurea were randomized.
Summary · context
Patients were randomized to receive once-daily oral semaglutide, 3 mg (n = 466), 7 mg (n = 466), or 14 mg (n = 465), or sitagliptin, 100 mg (n = 467).
Report a problemFND-3090379601
02HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes uncontrolled on metformin, oral semaglutide 14 mg/d reduced HbA1c more than sitagliptin at week 26.
In plain wordsIn adults with type 2 diabetes, oral semaglutide 14 mg lowered HbA1c more than sitagliptin after 26 weeks.
Peptide
Semaglutide
Outcome
DecreaseHbA1c change at week 26
Study
n: not reported in source
Comparator
Sitagliptin 100 mg
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
14 mg/d · oral · 26 weeksAs given in this study (human).
Measurements
HbA1c difference vs sitagliptin
−0.5%
semaglutide 14 mg/d, week 26
Source sentences
Summary
Semaglutide, 7 and 14 mg/d, compared with sitagliptin, significantly reduced HbA1c (differences, -0.3% [95% CI, -0.4% to -0.1%] and -0.5% [95% CI, -0.6% to -0.4%]
2 context sentences(design, population, supporting numbers)
Summary · context
Of 2463 patients screened, 1864 adults with type 2 diabetes uncontrolled with metformin with or without sulfonylurea were randomized.
Summary · context
Patients were randomized to receive once-daily oral semaglutide, 3 mg (n = 466), 7 mg (n = 466), or 14 mg (n = 465), or sitagliptin, 100 mg (n = 467).
Report a problemFND-3090379602
03HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, noninferiority of oral semaglutide 3 mg/d to sitagliptin for HbA1c was not demonstrated.
In plain wordsIn adults with type 2 diabetes, oral semaglutide 3 mg did not show HbA1c lowering at least as good as sitagliptin.
Peptide
Semaglutide
Outcome
No significant changeHbA1c noninferiority at 3 mg/d
Study
n: not reported in source
Comparator
Sitagliptin 100 mg
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
3 mg/d · oral · 26 weeksAs given in this study (human).
Source sentences
Summary
Noninferiority of semaglutide, 3 mg/d, with respect to HbA1c was not demonstrated.
2 context sentences(design, population, supporting numbers)
Summary · context
Of 2463 patients screened, 1864 adults with type 2 diabetes uncontrolled with metformin with or without sulfonylurea were randomized.
Summary · context
Patients were randomized to receive once-daily oral semaglutide, 3 mg (n = 466), 7 mg (n = 466), or 14 mg (n = 465), or sitagliptin, 100 mg (n = 467).
Report a problemFND-3090379605
04HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes uncontrolled on metformin, oral semaglutide 7 mg/d reduced body weight more than sitagliptin at week 26.
In plain wordsIn adults with type 2 diabetes, oral semaglutide 7 mg led to more weight loss than sitagliptin after 26 weeks.
Peptide
Semaglutide
Outcome
DecreaseBody weight change at week 26
Study
n: not reported in source
Comparator
Sitagliptin 100 mg
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Studied dose
7 mg/d · oral · 26 weeksAs given in this study (human).
Measurements
Body weight difference vs sitagliptin
−1.6 kg
semaglutide 7 mg/d, week 26
Source sentences
Summary
Semaglutide, 7 and 14 mg/d, compared with sitagliptin, significantly reduced HbA1c (differences, -0.3% [95% CI, -0.4% to -0.1%] and -0.5% [95% CI, -0.6% to -0.4%], respectively; P < .001 for both) and body weight (differences, -1.6 kg [95% CI, -2.0 to -1.1 kg] and -2.5 kg [95% CI, -3.0 to -2.0 kg],…
2 context sentences(design, population, supporting numbers)
Summary · context
Of 2463 patients screened, 1864 adults with type 2 diabetes uncontrolled with metformin with or without sulfonylurea were randomized.
Summary · context
Patients were randomized to receive once-daily oral semaglutide, 3 mg (n = 466), 7 mg (n = 466), or 14 mg (n = 465), or sitagliptin, 100 mg (n = 467).
Report a problemFND-3090379603
05HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes uncontrolled on metformin, oral semaglutide 14 mg/d reduced body weight more than sitagliptin at week 26.
In plain wordsIn adults with type 2 diabetes, oral semaglutide 14 mg led to more weight loss than sitagliptin after 26 weeks.
Peptide
Semaglutide
Outcome
DecreaseBody weight change at week 26
Study
n: not reported in source
Comparator
Sitagliptin 100 mg
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Studied dose
14 mg/d · oral · 26 weeksAs given in this study (human).
Measurements
Body weight difference vs sitagliptin
−2.5 kg
semaglutide 14 mg/d, week 26
Source sentences
Summary
Semaglutide, 7 and 14 mg/d, compared with sitagliptin, significantly reduced HbA1c (differences, -0.3% [95% CI, -0.4% to -0.1%] and -0.5% [95% CI, -0.6% to -0.4%], respectively; P < .001 for both) and body weight (differences, -1.6 kg [95% CI, -2.0 to -1.1 kg] and -2.5 kg [95% CI, -3.0 to -2.0 kg],…
2 context sentences(design, population, supporting numbers)
Summary · context
Of 2463 patients screened, 1864 adults with type 2 diabetes uncontrolled with metformin with or without sulfonylurea were randomized.
Summary · context
Patients were randomized to receive once-daily oral semaglutide, 3 mg (n = 466), 7 mg (n = 466), or 14 mg (n = 465), or sitagliptin, 100 mg (n = 467).
Report a problemFND-3090379604
06HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, oral semaglutide 14 mg/d reduced HbA1c more than sitagliptin at week 78.
In plain wordsIn adults with type 2 diabetes, oral semaglutide 14 mg lowered HbA1c more than sitagliptin after 78 weeks.
Peptide
Semaglutide
Outcome
DecreaseHbA1c change at week 78
Study
n: not reported in source
Comparator
Sitagliptin 100 mg
Analysis
Secondary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
14 mg/d · oral · 78 weeksAs given in this study (human).
Source sentences
Summary
Week 78 reductions in both end points were statistically significantly greater with semaglutide, 14 mg/d, vs sitagliptin.
2 context sentences(design, population, supporting numbers)
Summary · context
Of 2463 patients screened, 1864 adults with type 2 diabetes uncontrolled with metformin with or without sulfonylurea were randomized.
Summary · context
Patients were randomized to receive once-daily oral semaglutide, 3 mg (n = 466), 7 mg (n = 466), or 14 mg (n = 465), or sitagliptin, 100 mg (n = 467).
Report a problemFND-3090379606
07HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, oral semaglutide 14 mg/d reduced body weight more than sitagliptin at week 78.
In plain wordsIn adults with type 2 diabetes, oral semaglutide 14 mg led to more weight loss than sitagliptin after 78 weeks.
Peptide
Semaglutide
Outcome
DecreaseBody weight change at week 78
Study
n: not reported in source
Comparator
Sitagliptin 100 mg
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Studied dose
14 mg/d · oral · 78 weeksAs given in this study (human).
Source sentences
Summary
Week 78 reductions in both end points were statistically significantly greater with semaglutide, 14 mg/d, vs sitagliptin.
2 context sentences(design, population, supporting numbers)
Summary · context
Of 2463 patients screened, 1864 adults with type 2 diabetes uncontrolled with metformin with or without sulfonylurea were randomized.
Summary · context
Patients were randomized to receive once-daily oral semaglutide, 3 mg (n = 466), 7 mg (n = 466), or 14 mg (n = 465), or sitagliptin, 100 mg (n = 467).
Report a problemFND-3090379607
08HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes, 16.7% of patients on oral semaglutide 3 mg/d discontinued treatment prematurely, against 13.1% on sitagliptin.
In plain wordsIn adults with type 2 diabetes, 16.7% stopped oral semaglutide 3 mg early, compared with 13.1% on sitagliptin.
Peptide
Semaglutide
Outcome
Not applicablePremature treatment discontinuation, 3 mg/d
Study
n: not reported in source
Comparator
Sitagliptin 100 mg
Outcome group
Adverse events · Whole body
Studied dose
3 mg/d · oral · 78 weeksAs given in this study (human).
Measurements
Premature discontinuation
16.7%
semaglutide 3 mg/d
Premature discontinuation
13.1%
sitagliptin
Source sentences
Summary
16.7% for semaglutide, 3 mg/d; 15.0% for semaglutide, 7 mg/d; 19.1% for semaglutide, 14 mg/d; and 13.1% for sitagliptin
2 context sentences(design, population, supporting numbers)
Summary · context
Of 2463 patients screened, 1864 adults with type 2 diabetes uncontrolled with metformin with or without sulfonylurea were randomized.
Summary · context
Patients were randomized to receive once-daily oral semaglutide, 3 mg (n = 466), 7 mg (n = 466), or 14 mg (n = 465), or sitagliptin, 100 mg (n = 467).
Report a problemFND-3090379608
09HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes, 15.0% of patients on oral semaglutide 7 mg/d discontinued treatment prematurely, against 13.1% on sitagliptin.
In plain wordsIn adults with type 2 diabetes, 15.0% stopped oral semaglutide 7 mg early, compared with 13.1% on sitagliptin.
Peptide
Semaglutide
Outcome
Not applicablePremature treatment discontinuation, 7 mg/d
Study
n: not reported in source
Comparator
Sitagliptin 100 mg
Outcome group
Adverse events · Whole body
Studied dose
7 mg/d · oral · 78 weeksAs given in this study (human).
Measurements
Premature discontinuation
15%
semaglutide 7 mg/d
Premature discontinuation
13.1%
sitagliptin
Source sentences
Summary
16.7% for semaglutide, 3 mg/d; 15.0% for semaglutide, 7 mg/d; 19.1% for semaglutide, 14 mg/d; and 13.1% for sitagliptin
2 context sentences(design, population, supporting numbers)
Summary · context
Of 2463 patients screened, 1864 adults with type 2 diabetes uncontrolled with metformin with or without sulfonylurea were randomized.
Summary · context
Patients were randomized to receive once-daily oral semaglutide, 3 mg (n = 466), 7 mg (n = 466), or 14 mg (n = 465), or sitagliptin, 100 mg (n = 467).
Report a problemFND-3090379609
10HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes, 19.1% of patients on oral semaglutide 14 mg/d discontinued treatment prematurely, against 13.1% on sitagliptin.
In plain wordsIn adults with type 2 diabetes, 19.1% stopped oral semaglutide 14 mg early, compared with 13.1% on sitagliptin.
Peptide
Semaglutide
Outcome
Not applicablePremature treatment discontinuation, 14 mg/d
Study
n: not reported in source
Comparator
Sitagliptin 100 mg
Outcome group
Adverse events · Whole body
Studied dose
14 mg/d · oral · 78 weeksAs given in this study (human).
Measurements
Premature discontinuation
19.1%
semaglutide 14 mg/d
Premature discontinuation
13.1%
sitagliptin
Source sentences
Summary
16.7% for semaglutide, 3 mg/d; 15.0% for semaglutide, 7 mg/d; 19.1% for semaglutide, 14 mg/d; and 13.1% for sitagliptin
2 context sentences(design, population, supporting numbers)
Summary · context
Of 2463 patients screened, 1864 adults with type 2 diabetes uncontrolled with metformin with or without sulfonylurea were randomized.
Summary · context
Patients were randomized to receive once-daily oral semaglutide, 3 mg (n = 466), 7 mg (n = 466), or 14 mg (n = 465), or sitagliptin, 100 mg (n = 467).
Report a problemFND-3090379610

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 postedNCT02607865

Efficacy and Long-term Safety of Oral Semaglutide Versus Sitagliptin in Subjects With Type 2 Diabetes

Novo Nordisk A/Sn = 1,86415 Feb 2016 to 28 Mar 2018

Diabetes · Diabetes Mellitus, Type 2

Trial page ClinicalTrials.govUpdated 20 Jul 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.

Version 2Current
11 Oct 2026, 00:50 UTC
Study results updated
Version 1
9 Oct 2026, 03:06 UTC
First added · source update from Europe PMC

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