Primary outcomeNumber· Weeks 0-57
Number of Treatment-emergent Adverse Events (TEAEs)
| Group | Value (Events) |
|---|---|
| Oral Semaglutide 3 mg | 330 |
| Oral Semaglutide 7 mg | 350 |
| Oral Semaglutide 14 mg | 324 |
| Dulaglutide 0.75 mg | 178 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataSafety and Efficacy of Oral Semaglutide Versus Dulaglutide Both in Combination With One OAD (Oral Antidiabetic Drug) in Japanese Subjects With Type 2 Diabetes
Short name PIONEER 10
NCTNCT03015220 (opens ClinicalTrials.gov in a new tab)Other idNN9924-4282Other idU1111-1181-4133Other idJapicCTI-173485
Overview
- Status
- Completed
- Phase
- Phase 3
- Enrollment
- 458 participants (actual)
- Sponsor
- Novo Nordisk A/S · Industry
- Design
- Randomized · Open label (no masking)
- Countries
1 country
Japan
- Start
- 10 Jan 2017
- Primary completion
- 12 Jul 2018
- Completion
- 12 Jul 2018
- First posted
- 9 Jan 2017 (estimated)
- Last update posted
- 2 Mar 2021
- Conditions
- Diabetes · Diabetes Mellitus, Type 2
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
201720182019
- Ph 3
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This trial is conducted in Asia. The aim of this trial is to investigate Safety and efficacy of oral semaglutide versus dulaglutide both in combination with one OAD (oral antidiabetic drug) in Japanese subjects with type 2 diabetes.
Interventions
- SemaglutideDrug
- DulaglutideDrug
Arms4
Experimental
Oral semaglutide 3 mg
Experimental
Oral semaglutide 7 mg
Experimental
Oral semaglutide 14 mg
Active comparator
Dulaglutide 0.75 mg
Primary outcomes1
Outcomes the sponsor listed as primary.
Number of Treatment-emergent Adverse Events (TEAEs)
Time frame · Weeks 0-57
Registry description
Treatment emergent adverse events (TEAEs) were recorded from week 0 to week 57 (52-week treatment period plus the 5-week follow-up period). Adverse events (AEs) with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period: Time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Secondary outcomes(20)
Change in HbA1c
Time frame · Week 0, week 26, week 52
Registry description
Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at weeks 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Change in Fasting Plasma Glucose
Time frame · Week 0, week 26, week 52
Registry description
Change from baseline (week 0) in fasting plasma glucose (FPG) was evaluated at weeks 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Change in Self-measured Plasma Glucose 7-point Profile (SMPG) - Mean 7-point Profile
Time frame · Week 0, week 26, week 52
Registry description
Change from baseline (week 0) in mean 7-point SMPG profile was evaluated at weeks 26 and 52. SMPG was recorded at the following 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after dinner and at bedtime. Mean 7-point profile was defined as the area under the profile, calculated using the trapezoidal method, divided by the measurement time. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Change in Self-measured Plasma Glucose (SMPG) - Mean Postprandial Increment Over All Meals
Time frame · Week 0, week 26, week 52
Registry description
Change from baseline (week 0) in the average of the post-prandial increments over all meals was evaluated at weeks 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Change in Body Weight (kg)
Time frame · Week 0, week 26, week 52
Registry description
Change from baseline (week 0) in body weight was evaluated at weeks 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Change in Body Weight (%)
Time frame · Week 0, week 26, week 52
Registry description
Relative change from baseline (week 0) in body weight (kg) was evaluated at weeks 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Change in Body Mass Index (BMI)
Time frame · Week 0, week 26, week 52
Registry description
Change from baseline (week 0) in BMI was evaluated at weeks 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Change in Waist Circumference
Time frame · Week 0, week 26, week 52
Registry description
Change from baseline (week 0) in waist circumference was evaluated at weeks 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Change in Fasting Total Cholesterol (Ratio to Baseline)
Time frame · Week 0, week 26, week 52
Registry description
Change from baseline (week 0) in fasting total cholesterol (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Change in Fasting Low-density Lipoprotein (LDL) - Cholesterol (Ratio to Baseline)
Time frame · Week 0, week 26, week 52
Registry description
Change from baseline (week 0) in fasting low-density lipoprotein (LDL) (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Change in Fasting High-density Lipoprotein (HDL) - Cholesterol (Ratio to Baseline)
Time frame · Week 0, week 26, week 52
Registry description
Change from baseline (week 0) in fasting high-density lipoprotein (HDL) (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Change in Fasting Very-low Density Lipoprotein (VLDL) - Cholesterol (Ratio to Baseline)
Time frame · Week 0, week 26, week 52
Registry description
Change from baseline (week 0) in fasting very-low density lipoprotein (VLDL) (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Change in Fasting Triglyceride (Ratio to Baseline)
Time frame · Week 0, week 26, week 52
Registry description
Change from baseline (week 0) in fasting triglycerides (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Participants Who Achieve HbA1c Below 7% (53 mmol/Mol), American Diabetes Association Target (Yes/No)
Time frame · Week 26, week 52
Registry description
Participants who achieved HbA1c below 7.0% (53 millimoles per mole \[mmol/mol\]) according to American Diabetes Association (ADA) target (yes/no) at weeks 26 and 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Participants Who Achieve HbA1c Below or Equal to 6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists Target (Yes/No)
Time frame · Week 26, week 52
Registry description
Participants who achieved HbA1c below or equal to 6.5% (48 mmol/mol), American Association of Clinical Endocrinologists (AACE) target (yes/no) at weeks 26 and 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Participants Who Achieve HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain (Yes/No)
Time frame · Week 26, week 52
Registry description
Participants who achieved HbA1c below 7.0% (53 mmol/mol) without severe or blood glucose (BG) confirmed symptomatic hypoglycaemia episodes and without weight gain (yes/no) at weeks 26 and 52 are presented. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia was defined as an episode with plasma glucose value \<3.1 mmol/L with symptoms consistent with hypoglycaemia. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Participants Who Achieve HbA1c Reduction More Than or Equal to 1% (10.9 mmol/Mol) and Weight Loss More Than or Equal to 3% (Yes/No)
Time frame · Week 26, week 52
Registry description
Participants who achieved HbA1c reduction more than or equal to 1% (10.9 mmol/mol) and weight loss more than or equal to 3% (yes/no) at weeks 26 and 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Participants Who Achieve Weight Loss More Than or Equal to 5% (Yes/No).
Time frame · Week 26, week 52
Registry description
Participants who achieved weight loss more than or equal to 5% (yes/no) at weeks 26 and 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Participants Who Achieve Weight Loss More Than or Equal to 10% (Yes/No)
Time frame · Week 26, week 52
Registry description
Participants who achieved weight loss more than or equal to 10% (yes/no) at weeks 26 and 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Time to Additional Anti-diabetic Medication
Time frame · Weeks 0-52
Registry description
Presented results are the number of participants who had taken additional anti-diabetic medication anytime during the periods, from week 0 to week 26 and week 0 to week 52. Additional anti-diabetic medication was defined as any new anti-diabetic medication used for more than 21 days with the initiation at or after randomisation (week 0) and before (planned) end-of-treatment, and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomisation and before (planned) end-of-treatment. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(7)
Secondary outcomeMean· Week 0, week 26, week 52
Change in HbA1c
| Group | Value (Percentage of HbA1c) | Spread |
|---|---|---|
| Oral Semaglutide 3 mg | -1.1 | 0.9 |
| Oral Semaglutide 7 mg | -1.7 | 0.9 |
| Oral Semaglutide 14 mg | -2.0 | 1.0 |
| Dulaglutide 0.75 mg | -1.6 | 0.9 |
Secondary outcomeMean· Week 0, week 26, week 52
Change in Fasting Plasma Glucose
| Group | Value (mmol/L) | Spread |
|---|---|---|
| Oral Semaglutide 3 mg | -1.23 | 1.54 |
| Oral Semaglutide 7 mg | -2.25 | 1.93 |
| Oral Semaglutide 14 mg | -2.72 | 1.86 |
| Dulaglutide 0.75 mg | -2.22 | 1.71 |
Secondary outcomeMean· Week 0, week 26, week 52
Change in Self-measured Plasma Glucose 7-point Profile (SMPG) - Mean 7-point Profile
| Group | Value (mmol/L) | Spread |
|---|---|---|
| Oral Semaglutide 3 mg | -1.8 | 2.2 |
| Oral Semaglutide 7 mg | -2.7 | 2.1 |
| Oral Semaglutide 14 mg | -3.5 | 2.3 |
| Dulaglutide 0.75 mg | -2.9 | 2.4 |
Secondary outcomeMean· Week 0, week 26, week 52
Change in Self-measured Plasma Glucose (SMPG) - Mean Postprandial Increment Over All Meals
| Group | Value (mmol/L) | Spread |
|---|---|---|
| Oral Semaglutide 3 mg | -0.9 | 2.5 |
| Oral Semaglutide 7 mg | -1.3 | 2.0 |
| Oral Semaglutide 14 mg | -1.2 | 2.4 |
| Dulaglutide 0.75 mg | -0.7 | 2.3 |
Secondary outcomeMean· Week 0, week 26, week 52
Change in Body Weight (kg)
| Group | Value (kg) | Spread |
|---|---|---|
| Oral Semaglutide 3 mg | -0.1 | 2.0 |
| Oral Semaglutide 7 mg | -1.0 | 3.0 |
| Oral Semaglutide 14 mg | -2.2 | 3.2 |
| Dulaglutide 0.75 mg | 0.3 | 2.1 |
Secondary outcomeMean· Week 0, week 26, week 52
Change in Body Weight (%)
| Group | Value (Percentage change) | Spread |
|---|---|---|
| Oral Semaglutide 3 mg | -0.28 | 2.79 |
| Oral Semaglutide 7 mg | -1.49 | 4.25 |
| Oral Semaglutide 14 mg | -3.21 | 4.32 |
| Dulaglutide 0.75 mg | 0.25 | 3.33 |
Secondary outcomeMean· Week 0, week 26, week 52
Change in Body Mass Index (BMI)
| Group | Value (Kilogram per square meter (kg/m^2)) | Spread |
|---|---|---|
| Oral Semaglutide 3 mg | -0.1 | 0.7 |
| Oral Semaglutide 7 mg | -0.4 | 1.1 |
| Oral Semaglutide 14 mg | -0.8 | 1.2 |
| Dulaglutide 0.75 mg | 0.1 | 0.8 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Oral Semaglutide 3 mgParticipants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52. | 0 / 131 | 9 / 131 | 65 / 131 |
| Oral Semaglutide 7 mgParticipants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52. | 0 / 132 | 4 / 132 | 79 / 132 |
| Oral Semaglutide 14 mgParticipants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52. | 0 / 130 | 7 / 130 | 84 / 130 |
| Dulaglutide 0.75 mgParticipants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52. | 0 / 65 | 1 / 65 | 36 / 65 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies5
Studies that cite this trial.
Studies with results
2 studies on this page
PubMed tag: none · 2021
14 results
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 et al. 2021Diabetes therapy : research, treatment and education of diabetes and related disorderscited by 12
PMID 33460016PMC7846658DOI 10.1007/s13300-020-00985-wPUB-33460016
Free to read · publisher termsCC BY-NC14 results
Indexing hint: Randomized controlled trial · 2020
28 results
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 et al. 2020The lancet. Diabetes & endocrinologycited by 153
PMID 32333876DOI 10.1016/s2213-8587(20)30074-7PUB-32333876
Full text at the publisher28 results
More studies
3 studies on this page
PubMed tag: none · 2020
Semaglutide (SUSTAIN and PIONEER) reduces cardiovascular events in type 2 diabetes across varying cardiovascular risk.
Husain et al. 2020Diabetes, obesity & metabolismcited by 154
PMID 31903692PMC7064975DOI 10.1111/dom.13955PUB-31903692
Free to read · publisher termsCC BY-NC
Indexing hint: Review · 2020
Efficacy, safety and cardiovascular outcomes of once-daily oral semaglutide in patients with type 2 diabetes: The PIONEER programme.
Thethi et al. 2020Diabetes, obesity & metabolismcited by 98
PMID 32267058PMC7384149DOI 10.1111/dom.14054PUB-32267058
Free to read · publisher termsCC BY-NC
PubMed tag: none · 2020
Effects of semaglutide on risk of cardiovascular events across a continuum of cardiovascular risk: combined post hoc analysis of the SUSTAIN and PIONEER trials.
Husain et al. 2020Cardiovascular diabetologycited by 33
PMID 32998732PMC7526237DOI 10.1186/s12933-020-01106-4PUB-32998732
CC BY
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 20 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
* Japanese male or female, age above or equal to 20 years at the time of signing informed consent
* Diagnosed with type 2 diabetes mellitus for at least 60 days prior to day of screening
* HbA1c (glycosylated haemoglobin) between 7.0%-10.5% (53-91 mmol/mol) (both inclusive)
* OAD (oral antidiabetic drug) monotherapy with stable daily dose for at least 60 days prior to the day of screening of one of SU (sulphonylurea) glinide , TZD (thiazolidinedione), α-GI (alpha-glucosidase inhibitor) or SGLT-2 (sodium-glucose cotransporter-2) inhibitor according to Japanese labelling
Exclusion Criteria:
* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method. Adequate contraceptive measures are abstinence (not having sex), diaphragm, condom (by the partner), intrauterine device, sponge, spermicide or oral contraceptives
* Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol
* Family or personal history of multiple endocrine neoplasia type 2 (MEN 2) or medullary thyroid carcinoma (MTC)
* History of pancreatitis (acute or chronic)
* History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery)
* Any of the following: myocardial infarction, stroke or hospitalisation for unstable angina or transient ischaemic attack (TIA) within the past 180 days prior to the day of screening and randomisation
* Subjects presently classified as being in New York Heart Association (NYHA) Class IV
* Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
* Subjects with alanine aminotransferase (ALT) above 2.5 x upper normal limit (UNL)
* Renal impairment defined as estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m\^2 as per Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI)
* Treatment with once-weekly glucagon-like peptide-1 receptor agonists (GLP-1 RA) or once weekly dipeptidyl peptidase-4 (DPP-4) inhibitor in a period of 90 days before the day of screening
* For subjects treated with an OAD other than TZD at screening: Treatment with TZD in a period of 90 days before the day of screening
* Treatment with any medication for the indication of diabetes or obesity in addition to background OAD medication (SU, glinide, TZD, α-GI or SGLT-2 inhibitor) in a period of 60 days before the day of screening with the exception of short-term insulin treatment for acute illness for a total of at least 14 days
* Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus photography or dilated fundoscopy performed within 90 days prior to randomisation
* History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and in situ carcinomas)
* History of diabetic ketoacidosis
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