Effect of Oral Semaglutide Compared With Placebo and Subcutaneous Semaglutide on Glycemic Control in Patients With Type 2 Diabetes: A Randomized Clinical Trial.

Davies M, Pieber TR, Hartoft-Nielsen ML, Hansen OKH, Jabbour S, Rosenstock J

JAMA1 Oct 2017Cited by 382 (Europe PMC)

PMID29049653PMCIDPMC5817971DOI10.1001/jama.2017.14752PepBankPUB-29049653

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 study7

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

01HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, oral semaglutide reduced HbA1c significantly versus placebo at week 26 (estimated treatment difference range -0.4% to -1.6%).
In plain wordsIn adults with type 2 diabetes, daily oral semaglutide lowered HbA1c more than placebo after 26 weeks.
Peptide
Semaglutide
Outcome
DecreaseHbA1c change at week 26, oral semaglutide
Study
n: not reported in source
Comparator
Placebo
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
2.5-40 mg once daily · oral · 26 weeksAs given in this study (human).
Measurements
Estimated treatment difference
−1.6 to −0.4%
oral semaglutide vs placebo
Source sentences
Summary
oral semaglutide reductions were significant vs placebo (dosage-dependent estimated treatment difference [ETD] range for oral semaglutide vs placebo, -0.4% to -1.6%; P = .01 for 2.5 mg, <.001 for all other dosages).
2 context sentences(design, population, supporting numbers)
Summary · context
Phase 2, randomized, parallel-group, dosage-finding, 26-week trial with 5-week follow-up at 100 sites (hospital clinics, general practices, and clinical research centers) in 14 countries conducted between December 2013 and December 2014.
Summary · context
Of 1106 participants assessed, 632 with type 2 diabetes and insufficient glycemic control using diet and exercise alone or a stable dose of metformin were randomized.
Report a problemFND-2904965301
02HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, mean HbA1c fell by 1.9% with subcutaneous semaglutide and 0.3% with placebo at week 26.
In plain wordsIn adults with type 2 diabetes, weekly injected semaglutide lowered HbA1c by 1.9% after 26 weeks, compared with 0.3% with placebo.
Peptide
Semaglutide
Outcome
DecreaseHbA1c change at week 26, subcutaneous semaglutide
Study
n: not reported in source
Comparator
Placebo
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
1.0 mg once weekly · subcutaneous · 26 weeksAs given in this study (human).
Measurements
HbA1c change
−1.9%
subcutaneous semaglutide 1.0 mg
Source sentences
Summary
Mean change in HbA1c level from baseline to week 26 decreased with oral semaglutide (dosage-dependent range, -0.7% to -1.9%) and subcutaneous semaglutide (-1.9%) and placebo (-0.3%)
2 context sentences(design, population, supporting numbers)
Summary · context
Phase 2, randomized, parallel-group, dosage-finding, 26-week trial with 5-week follow-up at 100 sites (hospital clinics, general practices, and clinical research centers) in 14 countries conducted between December 2013 and December 2014.
Summary · context
Of 1106 participants assessed, 632 with type 2 diabetes and insufficient glycemic control using diet and exercise alone or a stable dose of metformin were randomized.
Report a problemFND-2904965302
03HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes, adverse events were reported by 63% to 86% on oral semaglutide versus 68% with placebo; mild to moderate gastrointestinal events were most common.
In plain wordsIn adults with type 2 diabetes, side effects were reported by 63% to 86% on oral semaglutide and 68% on placebo.
Peptide
Semaglutide
Outcome
MixedAdverse events, oral semaglutide
Study
n = 490
Comparator
Placebo
Analysis
Secondary
Outcome group
Adverse events · Whole body
Studied dose
2.5-40 mg once daily · oral · 26 weeksAs given in this study (human).
Source sentences
Summary
Adverse events were reported by 63% to 86% (371 of 490 patients) in the oral semaglutide groups, 81% (56 of 69 patients) in the subcutaneous semaglutide group, and 68% (48 of 71 patients) in the placebo group; mild to moderate gastrointestinal events were most common.
2 context sentences(design, population, supporting numbers)
Summary · context
Phase 2, randomized, parallel-group, dosage-finding, 26-week trial with 5-week follow-up at 100 sites (hospital clinics, general practices, and clinical research centers) in 14 countries conducted between December 2013 and December 2014.
Summary · context
Of 1106 participants assessed, 632 with type 2 diabetes and insufficient glycemic control using diet and exercise alone or a stable dose of metformin were randomized.
Report a problemFND-2904965305
04HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes, mild to moderate gastrointestinal events were the most common adverse events with oral semaglutide.
In plain wordsIn adults with type 2 diabetes, the most common side effects of oral semaglutide were mild to moderate digestive problems.
Peptide
Semaglutide
Outcome
Not applicableGastrointestinal adverse events
Study
n = 490
Analysis
Secondary
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
2.5-40 mg once daily · oral · 26 weeksAs given in this study (human).
Source sentences
Summary
mild to moderate gastrointestinal events were most common.
2 context sentences(design, population, supporting numbers)
Summary · context
Phase 2, randomized, parallel-group, dosage-finding, 26-week trial with 5-week follow-up at 100 sites (hospital clinics, general practices, and clinical research centers) in 14 countries conducted between December 2013 and December 2014.
Summary · context
Of 1106 participants assessed, 632 with type 2 diabetes and insufficient glycemic control using diet and exercise alone or a stable dose of metformin were randomized.
Report a problemFND-2904965307
05HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes, adverse events were reported by 81% on subcutaneous semaglutide versus 68% with placebo (numerically higher, no test reported).
In plain wordsIn adults with type 2 diabetes, side effects were reported by 81% on injected semaglutide and 68% on placebo, mostly mild or moderate digestive effects.
Peptide
Semaglutide
Outcome
IncreaseAdverse events, subcutaneous semaglutide
Study
n = 69
Comparator
Placebo
Analysis
Secondary
Outcome group
Adverse events · Whole body
Studied dose
1.0 mg once weekly · subcutaneous · 26 weeksAs given in this study (human).
Source sentences
Summary
81% (56 of 69 patients) in the subcutaneous semaglutide group, and 68% (48 of 71 patients) in the placebo group; mild to moderate gastrointestinal events were most common.
2 context sentences(design, population, supporting numbers)
Summary · context
Phase 2, randomized, parallel-group, dosage-finding, 26-week trial with 5-week follow-up at 100 sites (hospital clinics, general practices, and clinical research centers) in 14 countries conducted between December 2013 and December 2014.
Summary · context
Of 1106 participants assessed, 632 with type 2 diabetes and insufficient glycemic control using diet and exercise alone or a stable dose of metformin were randomized.
Report a problemFND-2904965306
06HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, oral semaglutide reduced body weight versus placebo; the reduction was significant for doses of 10 mg or more (estimated treatment difference -0.9 to -5.7 kg).
In plain wordsIn adults with type 2 diabetes, daily oral semaglutide reduced weight more than placebo, with significant effects from 10 mg upward.
Peptide
Semaglutide
Outcome
DecreaseBody weight change, oral semaglutide
Study
n: not reported in source
Comparator
Placebo
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Studied dose
2.5-40 mg once daily · oral · 26 weeksAs given in this study (human).
Measurements
Estimated treatment difference
−5.7 to −0.9 kg
oral semaglutide 10 mg or more vs placebo
Source sentences
Summary
Reductions in body weight were greater with oral semaglutide (dosage-dependent range, -2.1 kg to -6.9 kg) and subcutaneous semaglutide (-6.4 kg) vs placebo (-1.2 kg), and significant for oral semaglutide dosages of 10 mg or more vs placebo (dosage-dependent ETD range, -0.9 to -5.7 kg; P < .001).
2 context sentences(design, population, supporting numbers)
Summary · context
Phase 2, randomized, parallel-group, dosage-finding, 26-week trial with 5-week follow-up at 100 sites (hospital clinics, general practices, and clinical research centers) in 14 countries conducted between December 2013 and December 2014.
Summary · context
Of 1106 participants assessed, 632 with type 2 diabetes and insufficient glycemic control using diet and exercise alone or a stable dose of metformin were randomized.
Report a problemFND-2904965303
07HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, body weight fell by 6.4 kg with subcutaneous semaglutide versus 1.2 kg with placebo at week 26.
In plain wordsIn adults with type 2 diabetes, weekly injected semaglutide cut body weight by 6.4 kg, compared with 1.2 kg with placebo.
Peptide
Semaglutide
Outcome
DecreaseBody weight change, subcutaneous semaglutide
Study
n: not reported in source
Comparator
Placebo
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Studied dose
1.0 mg once weekly · subcutaneous · 26 weeksAs given in this study (human).
Measurements
Body weight change
−6.4 kg
subcutaneous semaglutide 1.0 mg
Source sentences
Summary
and subcutaneous semaglutide (-6.4 kg) vs placebo (-1.2 kg), and significant for oral semaglutide dosages of 10 mg or more vs placebo (dosage-dependent ETD range, -0.9 to -5.7 kg; P < .001).
2 context sentences(design, population, supporting numbers)
Summary · context
Phase 2, randomized, parallel-group, dosage-finding, 26-week trial with 5-week follow-up at 100 sites (hospital clinics, general practices, and clinical research centers) in 14 countries conducted between December 2013 and December 2014.
Summary · context
Of 1106 participants assessed, 632 with type 2 diabetes and insufficient glycemic control using diet and exercise alone or a stable dose of metformin were randomized.
Report a problemFND-2904965304

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 2Results postedNCT01923181

Multiple Dose Trial Examining Dose Range, Escalation and Efficacy of Oral Semaglutide in Subjects With Type 2 Diabetes

Novo Nordisk A/Sn = 6322 Dec 2013 to 11 Dec 2014

Diabetes · Diabetes Mellitus, Type 2

Trial page ClinicalTrials.govUpdated 15 Jan 2021

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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