Effect of Orally Administered Semaglutide Versus Dulaglutide on Diabetes-Related Quality of Life in Japanese Patients with Type 2 Diabetes: The PIONEER 10 Randomized, Active-Controlled Trial.

Ishii H, Hansen BB, Langer J, Horio H

Diabetes therapy : research, treatment and education of diabetes and related disorders18 Jan 2021Cited by 12 (Europe PMC)

PMID33460016PMCIDPMC7846658DOI10.1007/s13300-020-00985-wPepBankPUB-33460016

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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 study14

14 results from studies that gave the peptide. 14 results from people.

01HumanRandomized controlled trialEfficacy outcome
In Japanese T2D patients, oral semaglutide 7 mg improved total quality-of-life score more than dulaglutide 0.75 mg.
In plain wordsIn Japanese patients with diabetes, oral semaglutide improved overall quality of life more than dulaglutide.
Peptide
Semaglutide
Outcome
IncreaseDTR-QoL total score
Study
n: not reported in source
Comparator
Dulaglutide 0.75 mg
Outcome group
Quality of life · Whole body
Studied dose
7 mg daily · oral · 52 weeksAs given in this study (human).
Measurements
Score change
7.3 points
semaglutide 7 mg
Score change
3.3 points
dulaglutide 0.75 mg
ETD
3.9 points
versus dulaglutide
Source sentences
Summary
Using the treatment policy estimand, orally administered semaglutide 7 and 14 mg improved HRQoL versus dulaglutide 0.75 mg for the total score (estimated mean change from baseline [CfB] 7.3 and 8.1 vs 3.3; estimated treatment difference [ETD] 3.9 and 4.8)
3 context sentences(design, population, supporting numbers)
Summary · context
Health-related quality of life (HRQoL) in PIONEER 10 was assessed using the Japanese-specific Diabetes Therapy-Related Quality of Life (DTR-QoL) questionnaire.
Summary · context
Two estimands were prespecified: treatment policy (regardless of treatment discontinuation or rescue medication use) and trial product (assuming on treatment without rescue medication) in all randomized patients.
Summary · context
Outcomes were assessed at weeks 26 and 52.
Report a problemFND-3346001601
02HumanRandomized controlled trialEfficacy outcome
In Japanese T2D patients, oral semaglutide 14 mg improved total quality-of-life score more than dulaglutide 0.75 mg.
In plain wordsIn Japanese patients with diabetes, oral semaglutide improved overall quality of life more than dulaglutide.
Peptide
Semaglutide
Outcome
IncreaseDTR-QoL total score
Study
n: not reported in source
Comparator
Dulaglutide 0.75 mg
Outcome group
Quality of life · Whole body
Studied dose
14 mg daily · oral · 52 weeksAs given in this study (human).
Measurements
Score change
8.1 points
semaglutide 14 mg
Score change
3.3 points
dulaglutide 0.75 mg
ETD
4.8 points
versus dulaglutide
Source sentences
Summary
Using the treatment policy estimand, orally administered semaglutide 7 and 14 mg improved HRQoL versus dulaglutide 0.75 mg for the total score (estimated mean change from baseline [CfB] 7.3 and 8.1 vs 3.3; estimated treatment difference [ETD] 3.9 and 4.8)
3 context sentences(design, population, supporting numbers)
Summary · context
Health-related quality of life (HRQoL) in PIONEER 10 was assessed using the Japanese-specific Diabetes Therapy-Related Quality of Life (DTR-QoL) questionnaire.
Summary · context
Two estimands were prespecified: treatment policy (regardless of treatment discontinuation or rescue medication use) and trial product (assuming on treatment without rescue medication) in all randomized patients.
Summary · context
Outcomes were assessed at weeks 26 and 52.
Report a problemFND-3346001602
03HumanRandomized controlled trialEfficacy outcome
In Japanese T2D patients, oral semaglutide 7 mg improved anxiety and dissatisfaction scores more than dulaglutide 0.75 mg.
In plain wordsIn Japanese patients with diabetes, oral semaglutide improved treatment anxiety and dissatisfaction scores more than dulaglutide.
Peptide
Semaglutide
Outcome
IncreaseAnxiety and dissatisfaction domain
Study
n: not reported in source
Comparator
Dulaglutide 0.75 mg
Outcome group
Quality of life · Whole body
Studied dose
7 mg daily · oral · 52 weeksAs given in this study (human).
Measurements
Score change
9.7 points
semaglutide 7 mg
Score change
3.7 points
dulaglutide 0.75 mg
ETD
6 points
versus dulaglutide
Source sentences
Summary
and the "anxiety and dissatisfaction with treatment" domain (CfB 9.7 and 10.9 vs 3.7; ETD 6.0 and 7.2) at week 52.
4 context sentences(design, population, supporting numbers)
Summary · context
Using the treatment policy estimand, orally administered semaglutide 7 and 14 mg improved HRQoL versus dulaglutide 0.75 mg
Summary · context
Health-related quality of life (HRQoL) in PIONEER 10 was assessed using the Japanese-specific Diabetes Therapy-Related Quality of Life (DTR-QoL) questionnaire.
Summary · context
Two estimands were prespecified: treatment policy (regardless of treatment discontinuation or rescue medication use) and trial product (assuming on treatment without rescue medication) in all randomized patients.
Summary · context
Outcomes were assessed at weeks 26 and 52.
Report a problemFND-3346001603
04HumanRandomized controlled trialEfficacy outcome
In Japanese T2D patients, oral semaglutide 14 mg improved anxiety and dissatisfaction scores more than dulaglutide 0.75 mg.
In plain wordsIn Japanese patients with diabetes, oral semaglutide improved treatment anxiety and dissatisfaction scores more than dulaglutide.
Peptide
Semaglutide
Outcome
IncreaseAnxiety and dissatisfaction domain
Study
n: not reported in source
Comparator
Dulaglutide 0.75 mg
Outcome group
Quality of life · Whole body
Studied dose
14 mg daily · oral · 52 weeksAs given in this study (human).
Measurements
Score change
10.9 points
semaglutide 14 mg
Score change
3.7 points
dulaglutide 0.75 mg
ETD
7.2 points
versus dulaglutide
Source sentences
Summary
and the "anxiety and dissatisfaction with treatment" domain (CfB 9.7 and 10.9 vs 3.7; ETD 6.0 and 7.2) at week 52.
4 context sentences(design, population, supporting numbers)
Summary · context
Using the treatment policy estimand, orally administered semaglutide 7 and 14 mg improved HRQoL versus dulaglutide 0.75 mg
Summary · context
Health-related quality of life (HRQoL) in PIONEER 10 was assessed using the Japanese-specific Diabetes Therapy-Related Quality of Life (DTR-QoL) questionnaire.
Summary · context
Two estimands were prespecified: treatment policy (regardless of treatment discontinuation or rescue medication use) and trial product (assuming on treatment without rescue medication) in all randomized patients.
Summary · context
Outcomes were assessed at weeks 26 and 52.
Report a problemFND-3346001604
05HumanRandomized controlled trialEfficacy outcome
In Japanese T2D patients, oral semaglutide 14 mg improved treatment satisfaction scores more than dulaglutide 0.75 mg.
In plain wordsIn Japanese patients with diabetes, oral semaglutide improved treatment satisfaction more than dulaglutide.
Peptide
Semaglutide
Outcome
IncreaseTreatment satisfaction domain
Study
n: not reported in source
Comparator
Dulaglutide 0.75 mg
Outcome group
Quality of life · Whole body
Studied dose
14 mg daily · oral · 52 weeksAs given in this study (human).
Measurements
Score change
13.8 points
semaglutide 14 mg
Score change
5.7 points
dulaglutide 0.75 mg
ETD
8.1 points
versus dulaglutide
Source sentences
Summary
Orally administered semaglutide 14 mg improved the "satisfaction with treatment" domain versus dulaglutide 0.75 mg (CFB 13.8 vs 5.7; ETD 8.1).
3 context sentences(design, population, supporting numbers)
Summary · context
Health-related quality of life (HRQoL) in PIONEER 10 was assessed using the Japanese-specific Diabetes Therapy-Related Quality of Life (DTR-QoL) questionnaire.
Summary · context
Two estimands were prespecified: treatment policy (regardless of treatment discontinuation or rescue medication use) and trial product (assuming on treatment without rescue medication) in all randomized patients.
Summary · context
Outcomes were assessed at weeks 26 and 52.
Report a problemFND-3346001605
06HumanRandomized controlled trialEfficacy outcome
In Japanese T2D patients, dulaglutide 0.75 mg improved total quality-of-life score less than oral semaglutide 7 mg.
In plain wordsIn Japanese patients with diabetes, dulaglutide improved overall quality of life less than oral semaglutide.
Peptide
Dulaglutide (Trulicity)
Outcome
DecreaseDTR-QoL total score
Study
n: not reported in source
Comparator
Oral semaglutide 7 mg
Outcome group
Quality of life · Whole body
Studied dose
0.75 mg · 52 weeksAs given in this study (human).
Measurements
Score change
3.3 points
dulaglutide
ETD
3.9 points
oral semaglutide 7 mg minus dulaglutide
Source sentences
Summary
Using the treatment policy estimand, orally administered semaglutide 7 and 14 mg improved HRQoL versus dulaglutide 0.75 mg for the total score (estimated mean change from baseline [CfB] 7.3 and 8.1 vs 3.3; estimated treatment difference [ETD] 3.9 and 4.8)
3 context sentences(design, population, supporting numbers)
Summary · context
Health-related quality of life (HRQoL) in PIONEER 10 was assessed using the Japanese-specific Diabetes Therapy-Related Quality of Life (DTR-QoL) questionnaire.
Summary · context
Two estimands were prespecified: treatment policy (regardless of treatment discontinuation or rescue medication use) and trial product (assuming on treatment without rescue medication) in all randomized patients.
Summary · context
Outcomes were assessed at weeks 26 and 52.
Report a problemFND-3346001606
07HumanRandomized controlled trialEfficacy outcome
In Japanese T2D patients, dulaglutide 0.75 mg improved total quality-of-life score less than oral semaglutide 14 mg.
In plain wordsIn Japanese patients with diabetes, dulaglutide improved overall quality of life less than oral semaglutide.
Peptide
Dulaglutide (Trulicity)
Outcome
DecreaseDTR-QoL total score
Study
n: not reported in source
Comparator
Oral semaglutide 14 mg
Outcome group
Quality of life · Whole body
Studied dose
0.75 mg · 52 weeksAs given in this study (human).
Measurements
Score change
3.3 points
dulaglutide
ETD
4.8 points
oral semaglutide 14 mg minus dulaglutide
Source sentences
Summary
Using the treatment policy estimand, orally administered semaglutide 7 and 14 mg improved HRQoL versus dulaglutide 0.75 mg for the total score (estimated mean change from baseline [CfB] 7.3 and 8.1 vs 3.3; estimated treatment difference [ETD] 3.9 and 4.8)
3 context sentences(design, population, supporting numbers)
Summary · context
Health-related quality of life (HRQoL) in PIONEER 10 was assessed using the Japanese-specific Diabetes Therapy-Related Quality of Life (DTR-QoL) questionnaire.
Summary · context
Two estimands were prespecified: treatment policy (regardless of treatment discontinuation or rescue medication use) and trial product (assuming on treatment without rescue medication) in all randomized patients.
Summary · context
Outcomes were assessed at weeks 26 and 52.
Report a problemFND-3346001607
08HumanRandomized controlled trialEfficacy outcome
In Japanese T2D patients, dulaglutide 0.75 mg improved anxiety and dissatisfaction scores less than oral semaglutide 7 mg.
In plain wordsIn Japanese patients with diabetes, dulaglutide improved treatment anxiety and dissatisfaction scores less than oral semaglutide.
Peptide
Dulaglutide (Trulicity)
Outcome
DecreaseAnxiety and dissatisfaction domain
Study
n: not reported in source
Comparator
Oral semaglutide 7 mg
Outcome group
Quality of life · Whole body
Studied dose
0.75 mg · 52 weeksAs given in this study (human).
Measurements
Score change
3.7 points
dulaglutide
ETD
6 points
oral semaglutide 7 mg minus dulaglutide
Source sentences
Summary
and the "anxiety and dissatisfaction with treatment" domain (CfB 9.7 and 10.9 vs 3.7; ETD 6.0 and 7.2) at week 52.
4 context sentences(design, population, supporting numbers)
Summary · context
Using the treatment policy estimand, orally administered semaglutide 7 and 14 mg improved HRQoL versus dulaglutide 0.75 mg
Summary · context
Health-related quality of life (HRQoL) in PIONEER 10 was assessed using the Japanese-specific Diabetes Therapy-Related Quality of Life (DTR-QoL) questionnaire.
Summary · context
Two estimands were prespecified: treatment policy (regardless of treatment discontinuation or rescue medication use) and trial product (assuming on treatment without rescue medication) in all randomized patients.
Summary · context
Outcomes were assessed at weeks 26 and 52.
Report a problemFND-3346001608
09HumanRandomized controlled trialEfficacy outcome
In Japanese T2D patients, dulaglutide 0.75 mg improved anxiety and dissatisfaction scores less than oral semaglutide 14 mg.
In plain wordsIn Japanese patients with diabetes, dulaglutide improved treatment anxiety and dissatisfaction scores less than oral semaglutide.
Peptide
Dulaglutide (Trulicity)
Outcome
DecreaseAnxiety and dissatisfaction domain
Study
n: not reported in source
Comparator
Oral semaglutide 14 mg
Outcome group
Quality of life · Whole body
Studied dose
0.75 mg · 52 weeksAs given in this study (human).
Measurements
Score change
3.7 points
dulaglutide
ETD
7.2 points
oral semaglutide 14 mg minus dulaglutide
Source sentences
Summary
and the "anxiety and dissatisfaction with treatment" domain (CfB 9.7 and 10.9 vs 3.7; ETD 6.0 and 7.2) at week 52.
4 context sentences(design, population, supporting numbers)
Summary · context
Using the treatment policy estimand, orally administered semaglutide 7 and 14 mg improved HRQoL versus dulaglutide 0.75 mg
Summary · context
Health-related quality of life (HRQoL) in PIONEER 10 was assessed using the Japanese-specific Diabetes Therapy-Related Quality of Life (DTR-QoL) questionnaire.
Summary · context
Two estimands were prespecified: treatment policy (regardless of treatment discontinuation or rescue medication use) and trial product (assuming on treatment without rescue medication) in all randomized patients.
Summary · context
Outcomes were assessed at weeks 26 and 52.
Report a problemFND-3346001609
10HumanRandomized controlled trialEfficacy outcome
In Japanese T2D patients, dulaglutide 0.75 mg improved treatment satisfaction scores less than oral semaglutide 14 mg.
In plain wordsIn Japanese patients with diabetes, dulaglutide improved treatment satisfaction less than oral semaglutide.
Peptide
Dulaglutide (Trulicity)
Outcome
DecreaseTreatment satisfaction domain
Study
n: not reported in source
Comparator
Oral semaglutide 14 mg
Outcome group
Quality of life · Whole body
Studied dose
0.75 mg · 52 weeksAs given in this study (human).
Measurements
Score change
5.7 points
dulaglutide
ETD
8.1 points
oral semaglutide 14 mg minus dulaglutide
Source sentences
Summary
Orally administered semaglutide 14 mg improved the "satisfaction with treatment" domain versus dulaglutide 0.75 mg (CFB 13.8 vs 5.7; ETD 8.1).
3 context sentences(design, population, supporting numbers)
Summary · context
Health-related quality of life (HRQoL) in PIONEER 10 was assessed using the Japanese-specific Diabetes Therapy-Related Quality of Life (DTR-QoL) questionnaire.
Summary · context
Two estimands were prespecified: treatment policy (regardless of treatment discontinuation or rescue medication use) and trial product (assuming on treatment without rescue medication) in all randomized patients.
Summary · context
Outcomes were assessed at weeks 26 and 52.
Report a problemFND-3346001610
11HumanRandomized controlled trialEfficacy outcome
In Japanese T2D patients, oral semaglutide quality-of-life scores tended to persist longer than dulaglutide scores.
In plain wordsIn Japanese patients with diabetes, quality-of-life improvements tended to last longer with oral semaglutide than dulaglutide.
Peptide
Semaglutide
Outcome
IncreaseDTR-QoL durability
Study
n: not reported in source
Comparator
Dulaglutide
Outcome group
Quality of life · Whole body
Studied dose
Dose not stated · 52 weeksAs given in this study (human).
Source sentences
Summary
DTR-QoL scores for orally administered semaglutide tended to be more durable (sustained over time) than for dulaglutide.
3 context sentences(design, population, supporting numbers)
Summary · context
Health-related quality of life (HRQoL) in PIONEER 10 was assessed using the Japanese-specific Diabetes Therapy-Related Quality of Life (DTR-QoL) questionnaire.
Summary · context
Two estimands were prespecified: treatment policy (regardless of treatment discontinuation or rescue medication use) and trial product (assuming on treatment without rescue medication) in all randomized patients.
Summary · context
Outcomes were assessed at weeks 26 and 52.
Report a problemFND-3346001611
12HumanRandomized controlled trialEfficacy outcome
In Japanese T2D patients, dulaglutide quality-of-life scores tended to be less durable than oral semaglutide scores.
In plain wordsIn Japanese patients with diabetes, quality-of-life improvements tended to last less long with dulaglutide than oral semaglutide.
Peptide
Dulaglutide (Trulicity)
Outcome
DecreaseDTR-QoL durability
Study
n: not reported in source
Comparator
Oral semaglutide
Outcome group
Quality of life · Whole body
Studied dose
Dose not stated · 52 weeksAs given in this study (human).
Source sentences
Summary
DTR-QoL scores for orally administered semaglutide tended to be more durable (sustained over time) than for dulaglutide.
3 context sentences(design, population, supporting numbers)
Summary · context
Health-related quality of life (HRQoL) in PIONEER 10 was assessed using the Japanese-specific Diabetes Therapy-Related Quality of Life (DTR-QoL) questionnaire.
Summary · context
Two estimands were prespecified: treatment policy (regardless of treatment discontinuation or rescue medication use) and trial product (assuming on treatment without rescue medication) in all randomized patients.
Summary · context
Outcomes were assessed at weeks 26 and 52.
Report a problemFND-3346001612
13HumanRandomized controlled trialEfficacy outcome
In Japanese T2D patients, oral semaglutide quality-of-life results under the trial product estimand resembled treatment policy results versus dulaglutide.
In plain wordsIn Japanese patients with diabetes, the alternative analysis gave similar quality-of-life results for oral semaglutide compared with dulaglutide.
Peptide
Semaglutide
Outcome
IncreaseTrial product estimand outcomes
Study
n: not reported in source
Comparator
Dulaglutide
Outcome group
Quality of life · Whole body
Studied dose
Dose not stated · 52 weeksAs given in this study (human).
Source sentences
Summary
Outcomes for the trial product estimand were similar.
3 context sentences(design, population, supporting numbers)
Summary · context
Health-related quality of life (HRQoL) in PIONEER 10 was assessed using the Japanese-specific Diabetes Therapy-Related Quality of Life (DTR-QoL) questionnaire.
Summary · context
Two estimands were prespecified: treatment policy (regardless of treatment discontinuation or rescue medication use) and trial product (assuming on treatment without rescue medication) in all randomized patients.
Summary · context
Outcomes were assessed at weeks 26 and 52.
Report a problemFND-3346001613
14HumanRandomized controlled trialEfficacy outcome
In Japanese T2D patients, dulaglutide quality-of-life results under the trial product estimand resembled treatment policy results versus oral semaglutide.
In plain wordsIn Japanese patients with diabetes, the alternative analysis gave similar quality-of-life results for dulaglutide compared with oral semaglutide.
Peptide
Dulaglutide (Trulicity)
Outcome
DecreaseTrial product estimand outcomes
Study
n: not reported in source
Comparator
Oral semaglutide
Outcome group
Quality of life · Whole body
Studied dose
Dose not stated · 52 weeksAs given in this study (human).
Source sentences
Summary
Outcomes for the trial product estimand were similar.
3 context sentences(design, population, supporting numbers)
Summary · context
Health-related quality of life (HRQoL) in PIONEER 10 was assessed using the Japanese-specific Diabetes Therapy-Related Quality of Life (DTR-QoL) questionnaire.
Summary · context
Two estimands were prespecified: treatment policy (regardless of treatment discontinuation or rescue medication use) and trial product (assuming on treatment without rescue medication) in all randomized patients.
Summary · context
Outcomes were assessed at weeks 26 and 52.
Report a problemFND-3346001614

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.

Version 3Current
22 Oct 2026, 02:25 UTC
Study results updated
Version 2
21 Oct 2026, 18:59 UTC
Study data updated · source update from Europe PMC
Version 1
9 Oct 2026, 03:06 UTC
First added · source update from Europe PMC