Long-term efficacy and safety of oral semaglutide and the effect of switching from sitagliptin to oral semaglutide in patients with type 2 diabetes: a 52-week, randomized, open-label extension of the PIONEER 7 trial.

Buse JB, Bode BW, Mertens A, Cho YM, Christiansen E, Hertz CL, Nielsen MA, Pieber TR

BMJ open diabetes research & care1 Dec 2020Cited by 27 (Europe PMC)

PMID33318068PMCIDPMC7737050DOI10.1136/bmjdrc-2020-001649PepBankPUB-33318068

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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 study7

7 results from studies that gave the peptide. 7 results from people.

01HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes who switched from sitagliptin, the HbA1c change from week 52 to 104 did not differ significantly between oral semaglutide and continued sitagliptin.
In plain wordsIn adults with type 2 diabetes, switching to oral semaglutide did not lower HbA1c significantly more than staying on sitagliptin.
Peptide
Semaglutide
Outcome
No significant changeHbA1c change week 52 to 104, oral semaglutide versus sitagliptin (switch part)
Study
n = 198
Comparator
Sitagliptin
Analysis
Secondary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
3, 7 or 14 mg (flexible) · oral · 52 weeksAs given in this study (human).
Measurements
HbA1c change
−0.2%
oral semaglutide
HbA1c change
0.1%
sitagliptin
Source sentences
Summary
In the switch part, mean changes in HbA_1c from week 52 to week 104 were -0.2% for oral semaglutide and 0.1% for sitagliptin (difference -0.3% (95% CI -0.6 to 0.0); p=0.0791 (superiority not confirmed)).
1 context sentence(design, population, supporting numbers)
Summary · context
Patients on oral semaglutide in the main phase continued treatment (n=184; durability part); those on sitagliptin were rerandomized to continued sitagliptin (n=98) or oral semaglutide (n=100; initiated at 3 mg) (switch part).
Report a problemFND-3331806803
02HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, body weight fell more with oral semaglutide than with sitagliptin after switching.
In plain wordsIn adults with type 2 diabetes, people who switched to oral semaglutide lost more weight than those who stayed on sitagliptin.
Peptide
Semaglutide
Outcome
DecreaseBody weight change week 52 to 104, oral semaglutide versus sitagliptin (switch part)
Study
n = 198
Comparator
Sitagliptin
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Studied dose
3, 7 or 14 mg (flexible) · oral · 52 weeksAs given in this study (human).
Measurements
Body weight change
−2.4 kg
oral semaglutide
Body weight change
−0.9 kg
sitagliptin
Difference
−1.5 kg
oral semaglutide vs sitagliptin
Source sentences
Summary
Respective mean changes in body weight were -2.4 kg and -0.9 kg (difference -1.5 kg (95% CI -2.8 to -0.1); p=0.0321).
1 context sentence(design, population, supporting numbers)
Summary · context
Patients on oral semaglutide in the main phase continued treatment (n=184; durability part); those on sitagliptin were rerandomized to continued sitagliptin (n=98) or oral semaglutide (n=100; initiated at 3 mg) (switch part).
Report a problemFND-3331806806
03HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes who continued oral semaglutide, HbA1c stayed reduced from week 0 at weeks 52 and 104.
In plain wordsIn adults with type 2 diabetes who continued oral semaglutide, HbA1c stayed lower than at the start for two years.
Peptide
Semaglutide
Outcome
DecreaseHbA1c change from week 0 at weeks 52 and 104 (durability part)
Study
n = 184
Analysis
Secondary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
3, 7 or 14 mg (flexible) · oral · 104 weeksAs given in this study (human).
Measurements
HbA1c change from week 0
−1.5%
week 52
HbA1c change from week 0
−1.3%
week 104
Source sentences
Summary
In the durability part, mean (SD) changes in HbA_1c and body weight from week 0 were -1.5% (0.8) and -1.3% (1.0) and -2.8 kg (3.8) and -3.7 kg (5.2) at weeks 52 and 104, respectively
1 context sentence(design, population, supporting numbers)
Summary · context
Patients on oral semaglutide in the main phase continued treatment (n=184; durability part); those on sitagliptin were rerandomized to continued sitagliptin (n=98) or oral semaglutide (n=100; initiated at 3 mg) (switch part).
Report a problemFND-3331806801
04HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes who continued oral semaglutide, body weight stayed reduced from week 0 at weeks 52 and 104.
In plain wordsIn adults with type 2 diabetes who continued oral semaglutide, body weight stayed lower than at the start for two years.
Peptide
Semaglutide
Outcome
DecreaseBody weight change from week 0 at weeks 52 and 104 (durability part)
Study
n = 184
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Studied dose
3, 7 or 14 mg (flexible) · oral · 104 weeksAs given in this study (human).
Measurements
Body weight change from week 0
−2.8 kg
week 52
Body weight change from week 0
−3.7 kg
week 104
Source sentences
Summary
In the durability part, mean (SD) changes in HbA_1c and body weight from week 0 were -1.5% (0.8) and -1.3% (1.0) and -2.8 kg (3.8) and -3.7 kg (5.2) at weeks 52 and 104, respectively
1 context sentence(design, population, supporting numbers)
Summary · context
Patients on oral semaglutide in the main phase continued treatment (n=184; durability part); those on sitagliptin were rerandomized to continued sitagliptin (n=98) or oral semaglutide (n=100; initiated at 3 mg) (switch part).
Report a problemFND-3331806802
05HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, more patients reached HbA1c below 7.0 % with oral semaglutide than with sitagliptin after switching.
In plain wordsIn adults with type 2 diabetes, more people reached the HbA1c target on oral semaglutide than on sitagliptin.
Peptide
Semaglutide
Outcome
IncreasePatients reaching HbA1c below 7.0 % (switch part)
Study
n = 198
Comparator
Sitagliptin
Outcome group
Glycemic control · Metabolic and weight
Studied dose
3, 7 or 14 mg (flexible) · oral · 52 weeksAs given in this study (human).
Measurements
Patients with HbA1c <7.0%
52.6%
oral semaglutide
Patients with HbA1c <7.0%
28.6%
sitagliptin
Source sentences
Summary
More patients achieved HbA_1c <7.0% with oral semaglutide (52.6%) than sitagliptin (28.6%; p=0.0011)
1 context sentence(design, population, supporting numbers)
Summary · context
Patients on oral semaglutide in the main phase continued treatment (n=184; durability part); those on sitagliptin were rerandomized to continued sitagliptin (n=98) or oral semaglutide (n=100; initiated at 3 mg) (switch part).
Report a problemFND-3331806804
06HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, fewer patients received rescue medication with oral semaglutide than with sitagliptin after switching.
In plain wordsIn adults with type 2 diabetes, fewer people needed extra glucose-lowering medicine on oral semaglutide than on sitagliptin.
Peptide
Semaglutide
Outcome
DecreaseRescue medication use (switch part)
Study
n = 198
Comparator
Sitagliptin
Outcome group
Glycemic control · Metabolic and weight
Studied dose
3, 7 or 14 mg (flexible) · oral · 52 weeksAs given in this study (human).
Measurements
Patients receiving rescue medication
9%
oral semaglutide
Patients receiving rescue medication
23.5%
sitagliptin
Source sentences
Summary
and fewer received rescue medication (9% vs 23.5%).
1 context sentence(design, population, supporting numbers)
Summary · context
Patients on oral semaglutide in the main phase continued treatment (n=184; durability part); those on sitagliptin were rerandomized to continued sitagliptin (n=98) or oral semaglutide (n=100; initiated at 3 mg) (switch part).
Report a problemFND-3331806805
07HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes, gastrointestinal adverse events were the most commonly reported adverse events with oral semaglutide.
In plain wordsIn adults with type 2 diabetes, stomach and gut side effects were the most common side effects of oral semaglutide.
Peptide
Semaglutide
Outcome
Not applicableGastrointestinal adverse events
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
3, 7 or 14 mg (flexible) · oralAs given in this study (human).
Source sentences
Summary
Gastrointestinal adverse events were the most commonly reported with oral semaglutide.
1 context sentence(design, population, supporting numbers)
Summary · context
Patients on oral semaglutide in the main phase continued treatment (n=184; durability part); those on sitagliptin were rerandomized to continued sitagliptin (n=98) or oral semaglutide (n=100; initiated at 3 mg) (switch part).
Report a problemFND-3331806807

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 postedNCT02849080

Efficacy and Safety of Oral Semaglutide Using a Flexible Dose Adjustment Based on Clinical Evaluation Versus Sitagliptin in Subjects With Type 2 Diabetes Mellitus.

Novo Nordisk A/Sn = 50420 Sept 2016 to 27 Mar 2019

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

Subjects

Terms as the source lists them.

Publication types

MeSH terms

Keywords

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