Oral Semaglutide Versus Empagliflozin in Patients With Type 2 Diabetes Uncontrolled on Metformin: The PIONEER 2 Trial.

Rodbard HW, Rosenstock J, Canani LH, Deerochanawong C, Gumprecht J, Lindberg SØ, Lingvay I, Søndergaard AL, Treppendahl MB, Montanya E

Diabetes care17 Sept 2019Cited by 343 (Europe PMC)

PMID31530666DOI10.2337/dc19-0883PepBankPUB-31530666

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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 study6

6 results from studies that gave the peptide. 6 results from people.

01HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes on metformin, oral semaglutide 14 mg reduced HbA1c more than empagliflozin 25 mg at week 26 (treatment policy estimand).
In plain wordsIn adults with type 2 diabetes, oral semaglutide lowered HbA1c more than empagliflozin after 26 weeks.
Peptide
Semaglutide
Outcome
DecreaseHbA1c change at week 26 (treatment policy)
Study
n = 822
Comparator
Empagliflozin 25 mg
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
14 mg · oral · 26 weeksAs given in this study (human).
Measurements
Estimated treatment difference
−0.4%
week 26, treatment policy
Source sentences
Summary
Oral semaglutide provided superior reductions in HbA_1c versus empagliflozin at week 26 (treatment policy -1.3% vs. -0.9% [-14 vs. -9 mmol/mol], estimated treatment difference [ETD] -0.4% [95% CI -0.6, -0.3] [-5 mmol/mol (-6, -3)]; P < 0.0001).
1 context sentence(design, population, supporting numbers)
Summary · context
Patients were randomized to once-daily open-label treatment with oral semaglutide 14 mg (n = 412) or empagliflozin 25 mg (n = 410) in a 52-week trial.
Report a problemFND-3153066601
02HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes on metformin, oral semaglutide 14 mg reduced HbA1c more than empagliflozin 25 mg at week 26 (trial product estimand).
In plain wordsIn adults with type 2 diabetes, oral semaglutide lowered HbA1c more than empagliflozin after 26 weeks while on treatment.
Peptide
Semaglutide
Outcome
DecreaseHbA1c change at week 26 (trial product estimand)
Study
n = 822
Comparator
Empagliflozin 25 mg
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
14 mg · oral · 26 weeksAs given in this study (human).
Measurements
Estimated treatment difference
−0.5%
week 26, trial product
Source sentences
Summary
The treatment difference in HbA_1c significantly favored oral semaglutide at week 26 for the trial product estimand (-1.4% vs. -0.9% [-15 vs. -9 mmol/mol], ETD -0.5% [95% CI -0.7, -0.4] [-6 mmol/mol (-7, -5)]; P P < 0.0001).
1 context sentence(design, population, supporting numbers)
Summary · context
Patients were randomized to once-daily open-label treatment with oral semaglutide 14 mg (n = 412) or empagliflozin 25 mg (n = 410) in a 52-week trial.
Report a problemFND-3153066602
03HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes on metformin, superior weight loss with oral semaglutide 14 mg versus empagliflozin 25 mg was not confirmed at week 26.
In plain wordsIn adults with type 2 diabetes, oral semaglutide did not show clearly more weight loss than empagliflozin after 26 weeks.
Peptide
Semaglutide
Outcome
No significant changeBody weight change at week 26 (treatment policy)
Study
n = 822
Comparator
Empagliflozin 25 mg
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Studied dose
14 mg · oral · 26 weeksAs given in this study (human).
Source sentences
Summary
Superior weight loss was not confirmed at week 26 (treatment policy)
1 context sentence(design, population, supporting numbers)
Summary · context
Patients were randomized to once-daily open-label treatment with oral semaglutide 14 mg (n = 412) or empagliflozin 25 mg (n = 410) in a 52-week trial.
Report a problemFND-3153066604
04HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes on metformin, oral semaglutide 14 mg reduced HbA1c significantly more than empagliflozin 25 mg at week 52 under both estimands.
In plain wordsIn adults with type 2 diabetes, oral semaglutide lowered HbA1c more than empagliflozin after 52 weeks.
Peptide
Semaglutide
Outcome
DecreaseHbA1c change at week 52
Study
n = 822
Comparator
Empagliflozin 25 mg
Outcome group
Glycemic control · Metabolic and weight
Studied dose
14 mg · oral · 52 weeksAs given in this study (human).
Source sentences
Summary
The treatment difference in HbA_1c significantly favored oral semaglutide at week 26 for the trial product estimand (-1.4% vs. -0.9% [-15 vs. -9 mmol/mol], ETD -0.5% [95% CI -0.7, -0.4] [-6 mmol/mol (-7, -5)]; P P < 0.0001).
1 context sentence(design, population, supporting numbers)
Summary · context
Patients were randomized to once-daily open-label treatment with oral semaglutide 14 mg (n = 412) or empagliflozin 25 mg (n = 410) in a 52-week trial.
Report a problemFND-3153066603
05HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes on metformin, oral semaglutide 14 mg reduced body weight more than empagliflozin 25 mg at week 52 (trial product estimand).
In plain wordsIn adults with type 2 diabetes, oral semaglutide led to more weight loss than empagliflozin after 52 weeks.
Peptide
Semaglutide
Outcome
DecreaseBody weight change at week 52 (trial product estimand)
Study
n = 822
Comparator
Empagliflozin 25 mg
Outcome group
Body weight · Metabolic and weight
Studied dose
14 mg · oral · 52 weeksAs given in this study (human).
Measurements
Weight change
−4.7 kg
oral semaglutide, week 52
Weight change
−3.8 kg
empagliflozin, week 52
Source sentences
Summary
but oral semaglutide was significantly better than empagliflozin at week 52 (trial product -4.7 vs. -3.8 kg; P = 0.0114).
1 context sentence(design, population, supporting numbers)
Summary · context
Patients were randomized to once-daily open-label treatment with oral semaglutide 14 mg (n = 412) or empagliflozin 25 mg (n = 410) in a 52-week trial.
Report a problemFND-3153066605
06HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes on metformin, gastrointestinal adverse events were more common with oral semaglutide 14 mg than with empagliflozin 25 mg.
In plain wordsIn adults with type 2 diabetes, stomach and gut side effects were more common with oral semaglutide than with empagliflozin.
Peptide
Semaglutide
Outcome
IncreaseGastrointestinal adverse events
Study
n = 822
Comparator
Empagliflozin 25 mg
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
14 mg · oral · 52 weeksAs given in this study (human).
Source sentences
Summary
Gastrointestinal adverse events were more common with oral semaglutide.
1 context sentence(design, population, supporting numbers)
Summary · context
Patients were randomized to once-daily open-label treatment with oral semaglutide 14 mg (n = 412) or empagliflozin 25 mg (n = 410) in a 52-week trial.
Report a problemFND-3153066606

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 postedNCT02863328

Efficacy and Safety of Oral Semaglutide Versus Empagliflozin in Subjects With Type 2 Diabetes Mellitus

Novo Nordisk A/Sn = 82210 Aug 2016 to 8 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

Subjects

Terms as the source lists them.

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