Safety and efficacy of oral semaglutide versus dulaglutide in Japanese patients with type 2 diabetes (PIONEER 10): an open-label, randomised, active-controlled, phase 3a trial.

Yabe D, Nakamura J, Kaneto H, Deenadayalan S, Navarria A, Gislum M, Inagaki N

The lancet. Diabetes & endocrinology1 May 2020Cited by 153 (Europe PMC)

PMID32333876DOI10.1016/s2213-8587(20)30074-7PepBankPUB-32333876

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Summary

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Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study28

28 results from studies that gave the peptide. 28 results from people.

01HumanRandomized controlled trialSafety outcome
In Japanese adults with type 2 diabetes, 80% of patients had adverse events with oral semaglutide 7 mg.
In plain wordsIn Japanese adults with type 2 diabetes, 80% of patients on oral semaglutide 7 mg had side effects.
Peptide
Semaglutide
Outcome
Not applicableAdverse events with oral semaglutide 7 mg
Study
n = 132
Analysis
Primary
Outcome group
Adverse events · Whole body
Studied dose
7 mg once daily · oral · 57 weeksAs given in this study (human).
Measurements
Patients with adverse events
80%
oral semaglutide 7 mg
Source sentences
Summary
106 (80%) of 132 with oral semaglutide 7 mg
1 context sentence(design, population, supporting numbers)
Summary · context
Patients aged 20 years and older with uncontrolled type 2 diabetes were randomly assigned (2:2:2:1) to receive once-daily oral semaglutide 3 mg, 7 mg, or 14 mg, or once-weekly subcutaneous dulaglutide 0·75 mg for 52 weeks, as an add-on to their background medication.
Report a problemFND-3233387602
02HumanRandomized controlled trialSafety outcome
In Japanese adults with type 2 diabetes, 77% of patients had adverse events with oral semaglutide 3 mg.
In plain wordsIn Japanese adults with type 2 diabetes, 77% of patients on oral semaglutide 3 mg had side effects.
Peptide
Semaglutide
Outcome
Not applicableAdverse events with oral semaglutide 3 mg
Study
n = 131
Analysis
Primary
Outcome group
Adverse events · Whole body
Studied dose
3 mg once daily · oral · 57 weeksAs given in this study (human).
Measurements
Patients with adverse events
77%
oral semaglutide 3 mg
Source sentences
Summary
Adverse events occurred in 101 (77%) of 131 patients with oral semaglutide 3 mg
1 context sentence(design, population, supporting numbers)
Summary · context
Patients aged 20 years and older with uncontrolled type 2 diabetes were randomly assigned (2:2:2:1) to receive once-daily oral semaglutide 3 mg, 7 mg, or 14 mg, or once-weekly subcutaneous dulaglutide 0·75 mg for 52 weeks, as an add-on to their background medication.
Report a problemFND-3233387601
03HumanRandomized controlled trialSafety outcome
In Japanese adults with type 2 diabetes, 85% of patients had adverse events with oral semaglutide 14 mg.
In plain wordsIn Japanese adults with type 2 diabetes, 85% of patients on oral semaglutide 14 mg had side effects.
Peptide
Semaglutide
Outcome
Not applicableAdverse events with oral semaglutide 14 mg
Study
n = 130
Analysis
Primary
Outcome group
Adverse events · Whole body
Studied dose
14 mg once daily · oral · 57 weeksAs given in this study (human).
Measurements
Patients with adverse events
85%
oral semaglutide 14 mg
Source sentences
Summary
111 (85%) of 130 with oral semaglutide 14 mg
1 context sentence(design, population, supporting numbers)
Summary · context
Patients aged 20 years and older with uncontrolled type 2 diabetes were randomly assigned (2:2:2:1) to receive once-daily oral semaglutide 3 mg, 7 mg, or 14 mg, or once-weekly subcutaneous dulaglutide 0·75 mg for 52 weeks, as an add-on to their background medication.
Report a problemFND-3233387603
04HumanRandomized controlled trialSafety outcome
In Japanese patients with type 2 diabetes, adverse events occurred in 53 of 65 dulaglutide recipients.
In plain wordsIn Japanese patients with diabetes, 53 of 65 dulaglutide recipients had adverse events.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableTreatment-emergent adverse events
Study
n = 65
Analysis
Primary
Outcome group
Adverse events · Whole body
Studied dose
0.75 mg weekly · subcutaneous · 52 weeksAs given in this study (human).
Measurements
Adverse events
82%
dulaglutide
Participants with adverse events
53 participants
dulaglutide
Source sentences
Summary
Adverse events occurred in 101 (77%) of 131 patients with oral semaglutide 3 mg, 106 (80%) of 132 with oral semaglutide 7 mg, 111 (85%) of 130 with oral semaglutide 14 mg, and 53 (82%) of 65 with dulaglutide.
1 context sentence(design, population, supporting numbers)
Summary · context
Patients aged 20 years and older with uncontrolled type 2 diabetes were randomly assigned (2:2:2:1) to receive once-daily oral semaglutide 3 mg, 7 mg, or 14 mg, or once-weekly subcutaneous dulaglutide 0·75 mg for 52 weeks, as an add-on to their background medication.
Report a problemFND-3233387620
05HumanRandomized controlled trialEfficacy outcome
In Japanese adults with type 2 diabetes, oral semaglutide 7 mg reduced HbA1c from baseline to week 52.
In plain wordsIn Japanese adults with type 2 diabetes, oral semaglutide 7 mg lowered HbA1c over 52 weeks.
Peptide
Semaglutide
Outcome
DecreaseHbA1c change at week 52, oral semaglutide 7 mg
Study
n = 132
Analysis
Secondary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
7 mg once daily · oral · 52 weeksAs given in this study (human).
Measurements
HbA1c change
−1.4 percentage points
oral semaglutide 7 mg
Source sentences
Summary
-1·4 percentage points (0·1) with oral semaglutide 7 mg
2 context sentences(design, population, supporting numbers)
Summary · context
Supportive secondary endpoints (not controlled for multiplicity) included mean change from baseline in HbA_1c and bodyweight at 52 weeks.
Summary · context
Patients aged 20 years and older with uncontrolled type 2 diabetes were randomly assigned (2:2:2:1) to receive once-daily oral semaglutide 3 mg, 7 mg, or 14 mg, or once-weekly subcutaneous dulaglutide 0·75 mg for 52 weeks, as an add-on to their background medication.
Report a problemFND-3233387611
06HumanRandomized controlled trialEfficacy outcome
In Japanese adults with type 2 diabetes, oral semaglutide 7 mg reduced body weight from baseline to week 52.
In plain wordsIn Japanese adults with type 2 diabetes, oral semaglutide 7 mg lowered body weight over 52 weeks.
Peptide
Semaglutide
Outcome
DecreaseBody weight change at week 52, oral semaglutide 7 mg
Study
n = 132
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Studied dose
7 mg once daily · oral · 52 weeksAs given in this study (human).
Measurements
Body weight change
−0.9 kg
oral semaglutide 7 mg
Source sentences
Summary
-0·9 kg (0·3) with oral semaglutide 7 mg
2 context sentences(design, population, supporting numbers)
Summary · context
Supportive secondary endpoints (not controlled for multiplicity) included mean change from baseline in HbA_1c and bodyweight at 52 weeks.
Summary · context
Patients aged 20 years and older with uncontrolled type 2 diabetes were randomly assigned (2:2:2:1) to receive once-daily oral semaglutide 3 mg, 7 mg, or 14 mg, or once-weekly subcutaneous dulaglutide 0·75 mg for 52 weeks, as an add-on to their background medication.
Report a problemFND-3233387615
07HumanRandomized controlled trialEfficacy outcome
In Japanese adults with type 2 diabetes, oral semaglutide 3 mg reduced HbA1c from baseline to week 52.
In plain wordsIn Japanese adults with type 2 diabetes, oral semaglutide 3 mg lowered HbA1c over 52 weeks.
Peptide
Semaglutide
Outcome
DecreaseHbA1c change at week 52, oral semaglutide 3 mg
Study
n = 131
Analysis
Secondary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
3 mg once daily · oral · 52 weeksAs given in this study (human).
Measurements
HbA1c change
−0.9 percentage points
oral semaglutide 3 mg
Source sentences
Summary
-0·9 percentage points (SE 0·1) with oral semaglutide 3 mg
2 context sentences(design, population, supporting numbers)
Summary · context
Supportive secondary endpoints (not controlled for multiplicity) included mean change from baseline in HbA_1c and bodyweight at 52 weeks.
Summary · context
Patients aged 20 years and older with uncontrolled type 2 diabetes were randomly assigned (2:2:2:1) to receive once-daily oral semaglutide 3 mg, 7 mg, or 14 mg, or once-weekly subcutaneous dulaglutide 0·75 mg for 52 weeks, as an add-on to their background medication.
Report a problemFND-3233387610
08HumanRandomized controlled trialEfficacy outcome
In Japanese adults with type 2 diabetes, body weight did not change from baseline to week 52 with oral semaglutide 3 mg.
In plain wordsIn Japanese adults with type 2 diabetes, body weight did not change over 52 weeks on oral semaglutide 3 mg.
Peptide
Semaglutide
Outcome
No significant changeBody weight change at week 52, oral semaglutide 3 mg
Study
n = 131
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Studied dose
3 mg once daily · oral · 52 weeksAs given in this study (human).
Measurements
Body weight change
0 kg
oral semaglutide 3 mg
Source sentences
Summary
0·0 kg (SE 0·3) with oral semaglutide 3 mg
2 context sentences(design, population, supporting numbers)
Summary · context
Supportive secondary endpoints (not controlled for multiplicity) included mean change from baseline in HbA_1c and bodyweight at 52 weeks.
Summary · context
Patients aged 20 years and older with uncontrolled type 2 diabetes were randomly assigned (2:2:2:1) to receive once-daily oral semaglutide 3 mg, 7 mg, or 14 mg, or once-weekly subcutaneous dulaglutide 0·75 mg for 52 weeks, as an add-on to their background medication.
Report a problemFND-3233387614
09HumanRandomized controlled trialEfficacy outcome
In Japanese adults with type 2 diabetes, oral semaglutide 14 mg reduced HbA1c from baseline to week 52.
In plain wordsIn Japanese adults with type 2 diabetes, oral semaglutide 14 mg lowered HbA1c over 52 weeks.
Peptide
Semaglutide
Outcome
DecreaseHbA1c change at week 52, oral semaglutide 14 mg
Study
n = 130
Analysis
Secondary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
14 mg once daily · oral · 52 weeksAs given in this study (human).
Measurements
HbA1c change
−1.7 percentage points
oral semaglutide 14 mg
Source sentences
Summary
-1·7 percentage points (0·1) with oral semaglutide 14 mg
2 context sentences(design, population, supporting numbers)
Summary · context
Supportive secondary endpoints (not controlled for multiplicity) included mean change from baseline in HbA_1c and bodyweight at 52 weeks.
Summary · context
Patients aged 20 years and older with uncontrolled type 2 diabetes were randomly assigned (2:2:2:1) to receive once-daily oral semaglutide 3 mg, 7 mg, or 14 mg, or once-weekly subcutaneous dulaglutide 0·75 mg for 52 weeks, as an add-on to their background medication.
Report a problemFND-3233387612
10HumanRandomized controlled trialEfficacy outcome
In Japanese adults with type 2 diabetes, oral semaglutide 14 mg reduced body weight from baseline to week 52.
In plain wordsIn Japanese adults with type 2 diabetes, oral semaglutide 14 mg lowered body weight over 52 weeks.
Peptide
Semaglutide
Outcome
DecreaseBody weight change at week 52, oral semaglutide 14 mg
Study
n = 130
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Studied dose
14 mg once daily · oral · 52 weeksAs given in this study (human).
Measurements
Body weight change
−1.6 kg
oral semaglutide 14 mg
Source sentences
Summary
-1·6 kg (0·3) with oral semaglutide 14 mg
2 context sentences(design, population, supporting numbers)
Summary · context
Supportive secondary endpoints (not controlled for multiplicity) included mean change from baseline in HbA_1c and bodyweight at 52 weeks.
Summary · context
Patients aged 20 years and older with uncontrolled type 2 diabetes were randomly assigned (2:2:2:1) to receive once-daily oral semaglutide 3 mg, 7 mg, or 14 mg, or once-weekly subcutaneous dulaglutide 0·75 mg for 52 weeks, as an add-on to their background medication.
Report a problemFND-3233387616
11HumanRandomized controlled trialEfficacy outcome
In Japanese patients with diabetes, HbA1c decreased by 1.4 percentage points with dulaglutide at week 52.
In plain wordsIn Japanese patients with diabetes, dulaglutide reduced HbA1c from baseline.
Peptide
Dulaglutide (Trulicity)
Outcome
DecreaseHbA1c change
Study
n = 65
Analysis
Secondary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
0.75 mg weekly · subcutaneous · 52 weeksAs given in this study (human).
Measurements
HbA1c change
−1.4 percentage points
dulaglutide
Source sentences
Summary
-1·4 percentage points (0·1) with dulaglutide
1 context sentence(design, population, supporting numbers)
Summary · context
Patients aged 20 years and older with uncontrolled type 2 diabetes were randomly assigned (2:2:2:1) to receive once-daily oral semaglutide 3 mg, 7 mg, or 14 mg, or once-weekly subcutaneous dulaglutide 0·75 mg for 52 weeks, as an add-on to their background medication.
Report a problemFND-3233387626
12HumanRandomized controlled trialEfficacy outcome
In Japanese patients with diabetes, bodyweight increased by 1.0 kg with dulaglutide at week 52.
In plain wordsIn Japanese patients with diabetes, bodyweight increased from baseline with dulaglutide.
Peptide
Dulaglutide (Trulicity)
Outcome
IncreaseBodyweight change
Study
n = 65
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Studied dose
0.75 mg weekly · subcutaneous · 52 weeksAs given in this study (human).
Measurements
Bodyweight change
1 kg
dulaglutide
Source sentences
Summary
and 1·0 kg (0·4) with dulaglutide
1 context sentence(design, population, supporting numbers)
Summary · context
Patients aged 20 years and older with uncontrolled type 2 diabetes were randomly assigned (2:2:2:1) to receive once-daily oral semaglutide 3 mg, 7 mg, or 14 mg, or once-weekly subcutaneous dulaglutide 0·75 mg for 52 weeks, as an add-on to their background medication.
Report a problemFND-3233387628
13HumanRandomized controlled trialEfficacy outcome
In Japanese adults with type 2 diabetes, oral semaglutide 14 mg reduced HbA1c significantly more than dulaglutide at week 52.
In plain wordsIn Japanese adults with type 2 diabetes, oral semaglutide 14 mg lowered HbA1c more than weekly dulaglutide over 52 weeks.
Peptide
Semaglutide
Outcome
DecreaseHbA1c at week 52, oral semaglutide 14 mg versus dulaglutide
Study
n: not reported in source
Comparator
Dulaglutide 0.75 mg once weekly
Analysis
Secondary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
14 mg once daily · oral · 52 weeksAs given in this study (human).
Measurements
Estimated treatment difference
−0.3%
oral semaglutide 14 mg versus dulaglutide
Source sentences
Summary
estimated treatment difference -0·3% [95% CI -0·6 to -0·1] for oral semaglutide 14 mg vs dulaglutide; p=0·0170
2 context sentences(design, population, supporting numbers)
Summary · context
Supportive secondary endpoints (not controlled for multiplicity) included mean change from baseline in HbA_1c and bodyweight at 52 weeks.
Summary · context
Patients aged 20 years and older with uncontrolled type 2 diabetes were randomly assigned (2:2:2:1) to receive once-daily oral semaglutide 3 mg, 7 mg, or 14 mg, or once-weekly subcutaneous dulaglutide 0·75 mg for 52 weeks, as an add-on to their background medication.
Report a problemFND-3233387613
14HumanRandomized controlled trialEfficacy outcome
In Japanese adults with type 2 diabetes, oral semaglutide 14 mg reduced body weight significantly more than dulaglutide at week 52.
In plain wordsIn Japanese adults with type 2 diabetes, oral semaglutide 14 mg lowered body weight more than weekly dulaglutide over 52 weeks.
Peptide
Semaglutide
Outcome
DecreaseBody weight at week 52, oral semaglutide 14 mg versus dulaglutide
Study
n: not reported in source
Comparator
Dulaglutide 0.75 mg once weekly
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Studied dose
14 mg once daily · oral · 52 weeksAs given in this study (human).
Measurements
Estimated treatment difference
−2.6 kg
oral semaglutide 14 mg versus dulaglutide
Source sentences
Summary
estimated treatment difference -2·6 kg [95% CI -3·5 to -1·6] for oral semaglutide 14 mg vs dulaglutide; p<0·0001
2 context sentences(design, population, supporting numbers)
Summary · context
Supportive secondary endpoints (not controlled for multiplicity) included mean change from baseline in HbA_1c and bodyweight at 52 weeks.
Summary · context
Patients aged 20 years and older with uncontrolled type 2 diabetes were randomly assigned (2:2:2:1) to receive once-daily oral semaglutide 3 mg, 7 mg, or 14 mg, or once-weekly subcutaneous dulaglutide 0·75 mg for 52 weeks, as an add-on to their background medication.
Report a problemFND-3233387617
15HumanRandomized controlled trialEfficacy outcome
In Japanese adults with type 2 diabetes, oral semaglutide 7 mg reduced body weight significantly more than dulaglutide by week 52.
In plain wordsIn Japanese adults with type 2 diabetes, oral semaglutide 7 mg lowered body weight more than weekly dulaglutide over 52 weeks.
Peptide
Semaglutide
Outcome
DecreaseBody weight at week 52, oral semaglutide 7 mg versus dulaglutide
Study
n: not reported in source
Comparator
Dulaglutide 0.75 mg once weekly
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Studied dose
7 mg once daily · oral · 52 weeksAs given in this study (human).
Source sentences
Summary
Once-daily oral semaglutide significantly reduced HbA_1c (14 mg dose) and bodyweight (7 mg and 14 mg doses) versus weekly subcutaneous dulaglutide 0·75 mg by week 52.
2 context sentences(design, population, supporting numbers)
Summary · context
Supportive secondary endpoints (not controlled for multiplicity) included mean change from baseline in HbA_1c and bodyweight at 52 weeks.
Summary · context
Patients aged 20 years and older with uncontrolled type 2 diabetes were randomly assigned (2:2:2:1) to receive once-daily oral semaglutide 3 mg, 7 mg, or 14 mg, or once-weekly subcutaneous dulaglutide 0·75 mg for 52 weeks, as an add-on to their background medication.
Report a problemFND-3233387618
16HumanRandomized controlled trialEfficacy outcome
In Japanese patients with diabetes, dulaglutide reduced HbA1c less than oral semaglutide 14 mg at week 52.
In plain wordsIn Japanese patients with diabetes, dulaglutide reduced HbA1c less than oral semaglutide 14 mg.
Peptide
Dulaglutide (Trulicity)
Outcome
IncreaseHbA1c versus semaglutide 14 mg
Study
n: not reported in source
Comparator
Oral semaglutide 14 mg daily
Analysis
Secondary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
0.75 mg weekly · subcutaneous · 52 weeksAs given in this study (human).
Measurements
Estimated treatment difference in HbA1c change (oral semaglutide 14 mg vs dulaglutide)
−0.3%
week 52
95% confidence interval of difference
−0.6 to −0.1%
reported treatment comparison
Source sentences
Summary
estimated treatment difference -0·3% [95% CI -0·6 to -0·1] for oral semaglutide 14 mg vs dulaglutide; p=0·0170).
1 context sentence(design, population, supporting numbers)
Summary · context
Patients aged 20 years and older with uncontrolled type 2 diabetes were randomly assigned (2:2:2:1) to receive once-daily oral semaglutide 3 mg, 7 mg, or 14 mg, or once-weekly subcutaneous dulaglutide 0·75 mg for 52 weeks, as an add-on to their background medication.
Report a problemFND-3233387627
17HumanRandomized controlled trialEfficacy outcome
In Japanese patients with diabetes, bodyweight was higher with dulaglutide than oral semaglutide 14 mg at week 52.
In plain wordsIn Japanese patients with diabetes, dulaglutide produced higher bodyweight than oral semaglutide 14 mg.
Peptide
Dulaglutide (Trulicity)
Outcome
IncreaseBodyweight versus semaglutide 14 mg
Study
n: not reported in source
Comparator
Oral semaglutide 14 mg daily
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Studied dose
0.75 mg weekly · subcutaneous · 52 weeksAs given in this study (human).
Measurements
Estimated treatment difference in bodyweight change (oral semaglutide 14 mg vs dulaglutide)
−2.6 kg
week 52
95% confidence interval of difference
−3.5 to −1.6 kg
reported treatment comparison
Source sentences
Summary
estimated treatment difference -2·6 kg [95% CI -3·5 to -1·6] for oral semaglutide 14 mg vs dulaglutide; p<0·0001).
1 context sentence(design, population, supporting numbers)
Summary · context
Patients aged 20 years and older with uncontrolled type 2 diabetes were randomly assigned (2:2:2:1) to receive once-daily oral semaglutide 3 mg, 7 mg, or 14 mg, or once-weekly subcutaneous dulaglutide 0·75 mg for 52 weeks, as an add-on to their background medication.
Report a problemFND-3233387629
18HumanRandomized controlled trialEfficacy outcome
In Japanese patients with diabetes, weight increased with dulaglutide but decreased with oral semaglutide 7 mg at week 52.
In plain wordsIn Japanese patients with diabetes, weight increased with dulaglutide but decreased with oral semaglutide 7 mg.
Peptide
Dulaglutide (Trulicity)
Outcome
IncreaseBodyweight versus oral semaglutide 7 mg
Study
n: not reported in source
Comparator
Oral semaglutide 7 mg daily
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Studied dose
0.75 mg weekly · subcutaneous · 52 weeksAs given in this study (human).
Measurements
Bodyweight change
1 kg
dulaglutide
Bodyweight change
−0.9 kg
oral semaglutide 7 mg
Source sentences
Summary
Once-daily oral semaglutide significantly reduced HbA_1c (14 mg dose) and bodyweight (7 mg and 14 mg doses) versus weekly subcutaneous dulaglutide 0·75 mg by week 52.
Summary
Estimated mean changes in bodyweight from baseline (72·1 kg) to week 52 were 0·0 kg (SE 0·3) with oral semaglutide 3 mg, -0·9 kg (0·3) with oral semaglutide 7 mg, -1·6 kg (0·3) with oral semaglutide 14 mg, and 1·0 kg (0·4) with dulaglutide
1 context sentence(design, population, supporting numbers)
Summary · context
Patients aged 20 years and older with uncontrolled type 2 diabetes were randomly assigned (2:2:2:1) to receive once-daily oral semaglutide 3 mg, 7 mg, or 14 mg, or once-weekly subcutaneous dulaglutide 0·75 mg for 52 weeks, as an add-on to their background medication.
Report a problemFND-3233387630
19HumanRandomized controlled trialSafety outcome
In Japanese adults with type 2 diabetes, no deaths were reported in the trial.
In plain wordsIn Japanese adults with type 2 diabetes, no deaths were reported in the trial.
Peptide
Semaglutide
Outcome
No significant changeDeaths
Study
n = 458
Outcome group
Mortality · Whole body
Studied dose
3 mg, 7 mg and 14 mg once daily · oral · 52 weeksAs given in this study (human).
Source sentences
Summary
No deaths or severe hypoglycaemic events were reported.
1 context sentence(design, population, supporting numbers)
Summary · context
Patients aged 20 years and older with uncontrolled type 2 diabetes were randomly assigned (2:2:2:1) to receive once-daily oral semaglutide 3 mg, 7 mg, or 14 mg, or once-weekly subcutaneous dulaglutide 0·75 mg for 52 weeks, as an add-on to their background medication.
Report a problemFND-3233387608
20HumanRandomized controlled trialSafety outcome
In Japanese adults with type 2 diabetes, no severe hypoglycaemic events were reported in the trial.
In plain wordsIn Japanese adults with type 2 diabetes, no severe low blood sugar events were reported in the trial.
Peptide
Semaglutide
Outcome
No significant changeSevere hypoglycaemic events
Study
n = 458
Outcome group
Adverse events · Metabolic and weight
Studied dose
3 mg, 7 mg and 14 mg once daily · oral · 52 weeksAs given in this study (human).
Source sentences
Summary
No deaths or severe hypoglycaemic events were reported.
1 context sentence(design, population, supporting numbers)
Summary · context
Patients aged 20 years and older with uncontrolled type 2 diabetes were randomly assigned (2:2:2:1) to receive once-daily oral semaglutide 3 mg, 7 mg, or 14 mg, or once-weekly subcutaneous dulaglutide 0·75 mg for 52 weeks, as an add-on to their background medication.
Report a problemFND-3233387609
21HumanRandomized controlled trialSafety outcome
In Japanese adults with type 2 diabetes, 6% of patients on oral semaglutide 7 mg stopped treatment early because of adverse events.
In plain wordsIn Japanese adults with type 2 diabetes, 6% of patients on oral semaglutide 7 mg stopped early because of side effects.
Peptide
Semaglutide
Outcome
Not applicableDiscontinuation due to adverse events, oral semaglutide 7 mg
Study
n = 132
Outcome group
Adverse events · Whole body
Studied dose
7 mg once daily · oral · 52 weeksAs given in this study (human).
Measurements
Discontinuation due to adverse events
6%
oral semaglutide 7 mg
Source sentences
Summary
eight (6%) of 132 receiving oral semaglutide 7 mg
1 context sentence(design, population, supporting numbers)
Summary · context
Patients aged 20 years and older with uncontrolled type 2 diabetes were randomly assigned (2:2:2:1) to receive once-daily oral semaglutide 3 mg, 7 mg, or 14 mg, or once-weekly subcutaneous dulaglutide 0·75 mg for 52 weeks, as an add-on to their background medication.
Report a problemFND-3233387606
22HumanRandomized controlled trialSafety outcome
In Japanese adults with type 2 diabetes, 3% of patients on oral semaglutide 3 mg stopped treatment early because of adverse events.
In plain wordsIn Japanese adults with type 2 diabetes, 3% of patients on oral semaglutide 3 mg stopped early because of side effects.
Peptide
Semaglutide
Outcome
Not applicableDiscontinuation due to adverse events, oral semaglutide 3 mg
Study
n = 131
Outcome group
Adverse events · Whole body
Studied dose
3 mg once daily · oral · 52 weeksAs given in this study (human).
Measurements
Discontinuation due to adverse events
3%
oral semaglutide 3 mg
Source sentences
Summary
Adverse events led to premature treatment discontinuation in four (3%) of 131 patients receiving oral semaglutide 3 mg
1 context sentence(design, population, supporting numbers)
Summary · context
Patients aged 20 years and older with uncontrolled type 2 diabetes were randomly assigned (2:2:2:1) to receive once-daily oral semaglutide 3 mg, 7 mg, or 14 mg, or once-weekly subcutaneous dulaglutide 0·75 mg for 52 weeks, as an add-on to their background medication.
Report a problemFND-3233387605
23HumanRandomized controlled trialSafety outcome
In Japanese adults with type 2 diabetes, 6% of patients on oral semaglutide 14 mg stopped treatment early because of adverse events.
In plain wordsIn Japanese adults with type 2 diabetes, 6% of patients on oral semaglutide 14 mg stopped early because of side effects.
Peptide
Semaglutide
Outcome
Not applicableDiscontinuation due to adverse events, oral semaglutide 14 mg
Study
n = 130
Outcome group
Adverse events · Whole body
Studied dose
14 mg once daily · oral · 52 weeksAs given in this study (human).
Measurements
Discontinuation due to adverse events
6%
oral semaglutide 14 mg
Source sentences
Summary
eight (6%) of 130 receiving oral semaglutide 14 mg
1 context sentence(design, population, supporting numbers)
Summary · context
Patients aged 20 years and older with uncontrolled type 2 diabetes were randomly assigned (2:2:2:1) to receive once-daily oral semaglutide 3 mg, 7 mg, or 14 mg, or once-weekly subcutaneous dulaglutide 0·75 mg for 52 weeks, as an add-on to their background medication.
Report a problemFND-3233387607
24HumanRandomized controlled trialSafety outcome
In Japanese patients with diabetes, adverse events caused premature treatment discontinuation in two dulaglutide recipients.
In plain wordsIn Japanese patients with diabetes, two dulaglutide recipients stopped treatment because of adverse events.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableDiscontinuation due to adverse events
Study
n = 65
Outcome group
Adverse events · Whole body
Studied dose
0.75 mg weekly · subcutaneous · 52 weeksAs given in this study (human).
Measurements
Discontinuation
3%
dulaglutide
Discontinuations due to adverse events
2 participants
dulaglutide
Source sentences
Summary
and two (3%) of 65 receiving dulaglutide.
1 context sentence(design, population, supporting numbers)
Summary · context
Patients aged 20 years and older with uncontrolled type 2 diabetes were randomly assigned (2:2:2:1) to receive once-daily oral semaglutide 3 mg, 7 mg, or 14 mg, or once-weekly subcutaneous dulaglutide 0·75 mg for 52 weeks, as an add-on to their background medication.
Report a problemFND-3233387623
25HumanRandomized controlled trialSafety outcome
In Japanese patients with diabetes, no deaths occurred in the trial, including the dulaglutide arm.
In plain wordsNo patients died in the trial, including those who received dulaglutide.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableDeaths
Study
n = 65
Outcome group
Mortality · Whole body
Studied dose
0.75 mg weekly · subcutaneous · 52 weeksAs given in this study (human).
Source sentences
Summary
No deaths or severe hypoglycaemic events were reported.
1 context sentence(design, population, supporting numbers)
Summary · context
Patients aged 20 years and older with uncontrolled type 2 diabetes were randomly assigned (2:2:2:1) to receive once-daily oral semaglutide 3 mg, 7 mg, or 14 mg, or once-weekly subcutaneous dulaglutide 0·75 mg for 52 weeks, as an add-on to their background medication.
Report a problemFND-3233387624
26HumanRandomized controlled trialSafety outcome
In Japanese patients with diabetes, no severe hypoglycaemic events occurred, including in the dulaglutide arm.
In plain wordsNo patients had severe low blood sugar, including those who received dulaglutide.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableSevere hypoglycaemia
Study
n = 65
Outcome group
Adverse events · Metabolic and weight
Studied dose
0.75 mg weekly · subcutaneous · 52 weeksAs given in this study (human).
Source sentences
Summary
No deaths or severe hypoglycaemic events were reported.
1 context sentence(design, population, supporting numbers)
Summary · context
Patients aged 20 years and older with uncontrolled type 2 diabetes were randomly assigned (2:2:2:1) to receive once-daily oral semaglutide 3 mg, 7 mg, or 14 mg, or once-weekly subcutaneous dulaglutide 0·75 mg for 52 weeks, as an add-on to their background medication.
Report a problemFND-3233387625
27HumanRandomized controlled trialSafety outcome
In Japanese adults with type 2 diabetes, gastrointestinal adverse events, mostly mild and transient constipation and nausea, occurred in a dose-dependent manner with oral semaglutide.
In plain wordsIn Japanese adults with type 2 diabetes, oral semaglutide caused more stomach and gut side effects at higher doses, mostly mild and brief.
Peptide
Semaglutide
Outcome
IncreaseGastrointestinal adverse events by oral semaglutide dose
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
3 mg, 7 mg and 14 mg once daily · oral · 52 weeksAs given in this study (human).
Source sentences
Summary
Gastrointestinal adverse events (mostly mild and transient constipation and nausea) occurred in a dose-dependent manner with oral semaglutide.
1 context sentence(design, population, supporting numbers)
Summary · context
Patients aged 20 years and older with uncontrolled type 2 diabetes were randomly assigned (2:2:2:1) to receive once-daily oral semaglutide 3 mg, 7 mg, or 14 mg, or once-weekly subcutaneous dulaglutide 0·75 mg for 52 weeks, as an add-on to their background medication.
Report a problemFND-3233387604
28HumanRandomized controlled trialSafety outcome
In Japanese adults with type 2 diabetes, the most common adverse events in the trial were infections and gastrointestinal events.
In plain wordsIn Japanese adults with type 2 diabetes, the most common side effects in the trial were infections and stomach or gut problems.
Peptide
Semaglutide
Outcome
Not applicableMost common adverse events
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
3 mg, 7 mg and 14 mg once daily · oral · 52 weeksAs given in this study (human).
Source sentences
Summary
The most common adverse events were infections and gastrointestinal events.
Report a problemFND-3233387619

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 postedNCT03015220

Safety and Efficacy of Oral Semaglutide Versus Dulaglutide Both in Combination With One OAD (Oral Antidiabetic Drug) in Japanese Subjects With Type 2 Diabetes

Novo Nordisk A/Sn = 45810 Jan 2017 to 12 Jul 2018

Diabetes · Diabetes Mellitus, Type 2

Trial page ClinicalTrials.govUpdated 2 Mar 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.

Versions 4 to 9Current
28 Oct 2026, 02:03 UTC
The same notice was added 6 times, first on 22 Oct 2026, 02:26 UTC. The status did not change between them.
Study results updated
Version 3
21 Oct 2026, 18:59 UTC
Study data updated · source update from Europe PMC
Version 2
11 Oct 2026, 00:50 UTC
Study results updated
Version 1
9 Oct 2026, 03:06 UTC
First added · source update from Europe PMC