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Safety and Efficacy of Oral Semaglutide Versus Dulaglutide Both in Combination With One OAD (Oral Antidiabetic Drug) in Japanese Subjects With Type 2 Diabetes (PIONEER 10)

Primary Purpose

Diabetes, Diabetes Mellitus, Type 2

Status

Completed

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

Semaglutide

Dulaglutide

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Arm Label

Oral semaglutide 3 mg

Oral semaglutide 7 mg

Oral semaglutide 14 mg

Dulaglutide 0.75 mg

Arm Description

Outcomes

Primary Outcome Measures

Number of Treatment-emergent Adverse Events (TEAEs)

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 Outcome Measures

Change in HbA1c

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

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

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

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)

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 (%)

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)

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

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)

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)

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)

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)

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)

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)

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)

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)

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)

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).

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)

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

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.

Time to Rescue Medication

Presented results are the number of participants who had taken rescue medication anytime during the periods, from week 0 to week 26 and week 0 to week 52. Rescue medication was defined as any new anti-diabetic medication used as add-on to trial product and used for more than 21 days with the initiation at or after randomisation (week 0) and before last day on trial product, 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 last day on trial product. Results are based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.

Change in Amylase (Ratio to Baseline)

Change from baseline (week 0) in amylase (measured as units per liter [U/L]) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

Change in Lipase (Ratio to Baseline)

Change from baseline (week 0) in lipase (measured as U/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

Change in Pulse Rate

Change from baseline (week 0) in pulse rate was evaluated at weeks 26 and 52. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

Change in Blood Pressure

Change from baseline (week 0) in blood pressure (systolic blood pressure [SBP] and diastolic blood pressure [DBP]) was evaluated at weeks 26 and 52. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

Change in ECG Evaluation

Change from baseline (week 0) in electrocardiogram (ECG) was evaluated at weeks 26 and 52. Change from baseline results are presented as shift in findings (normal, abnormal and not clinically significant (NCS) and abnormal and clinically significant (CS)) from week 0 to week 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 Physical Examination

Participants with physical examination findings, normal, abnormal NCS and abnormal CS at baseline (weeks -2), week 26 and weeks 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. Results are presented for the following examinations: 1) Cardiovascular system; 2) Central and peripheral nervous system; 3) Gastrointestinal system, incl. mouth; 4) General appearance; 5) Head, ears, eyes, nose, throat, neck; 6) Lymph node palpation; 7) Musculoskeletal system; 8) Respiratory system; 9) Skin; 10) Thyroid gland.

Change in Eye Examination Category

Participants with eye examination (fundoscopy) findings, normal, abnormal NCS and abnormal CS at baseline (week -2) and week 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.

Number of Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes

Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded during weeks 0-57 (52-week treatment period plus the 5-week follow-up period). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a subject was on treatment with trial product, including any period after initiation of rescue medication. 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: Confirmed by a glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.

Participants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes

Participants with treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded from week 0 to week 83 (78-week treatment period plus the 5-week follow-up period). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a subject was on treatment with trial product, including any period after initiation of rescue medication. 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: Confirmed by a glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.

Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)

SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ (acute version) questionnaire measured eight domains of functional health and well-being as well as two component summary scores (physical component summary (PCS) and mental component summary (MCS)). The 0-100 scale scores (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively of the 2009 U.S. general population. Change from baseline (week 0) in the domain scores and component summary (PCS and MCS) scores were evaluated at weeks 26 and 52. A positive change score indicates an improvement since baseline. Results are based on the data from the in-trial observation period.

Diabetes Therapy-Related Quality of Life (DTR-QoL): Total Score and Scores for the 4 Domains

DTR-QoL questionnaire is a 29-item patient-reported survey of patient health that measures the influence of diabetes treatment on health related-QoL on 4 domains on individual scale ranges: "Burden on social activities and daily activities", "Anxiety and dissatisfaction with treatment", "Hypoglycemia" and "Satisfaction with treatment" on a 7-point graded response scale. The domain score is calculated from the mean score of the attribute items, and the scoring range is converted to 0 - 100 (best-case response = 100; worst case response = 0). The total score, after simple addition of the item scores, is converted to 0 - 100 (best-case response = 100; worst case response = 0). Change from baseline (week 0) in the scores were evaluated at week 26, week 52. Data based on in-trial observation period is presented. W26 and W52 refer to week 26 and week 52 respectively.

Full Information

NCT ID

NCT03015220

First Posted

January 6, 2017

Last Updated

February 11, 2021

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT03015220

Brief Title

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

Acronym

PIONEER 10

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Completed

Study Start Date

January 10, 2017 (Actual)

Primary Completion Date

July 12, 2018 (Actual)

Study Completion Date

July 12, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novo Nordisk A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes, Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

458 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Oral semaglutide 3 mg

Arm Type

Experimental

Arm Title

Oral semaglutide 7 mg

Arm Type

Experimental

Arm Title

Oral semaglutide 14 mg

Arm Type

Experimental

Arm Title

Dulaglutide 0.75 mg

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Semaglutide

Intervention Description

Oral administration once-daily, as add-on to pre-trial oral antidiabetic drug (OAD).

Intervention Type

Drug

Intervention Name(s)

Dulaglutide

Intervention Description

Subcutaneously administration (s.c., under the skin) once-weekly, as add-on to pre-trial oral antidiabetic drug (OAD).

Primary Outcome Measure Information:

Title

Number of Treatment-emergent Adverse Events (TEAEs)

Description

Time Frame

Weeks 0-57

Secondary Outcome Measure Information:

Title

Change in HbA1c

Description

Time Frame

Week 0, week 26, week 52

Title

Change in Fasting Plasma Glucose

Description

Time Frame

Week 0, week 26, week 52

Title

Change in Self-measured Plasma Glucose 7-point Profile (SMPG) - Mean 7-point Profile

Description

Time Frame

Week 0, week 26, week 52

Title

Change in Self-measured Plasma Glucose (SMPG) - Mean Postprandial Increment Over All Meals

Description

Time Frame

Week 0, week 26, week 52

Title

Change in Body Weight (kg)

Description

Time Frame

Week 0, week 26, week 52

Title

Change in Body Weight (%)

Description

Time Frame

Week 0, week 26, week 52

Title

Change in Body Mass Index (BMI)

Description

Time Frame

Week 0, week 26, week 52

Title

Change in Waist Circumference

Description

Time Frame

Week 0, week 26, week 52

Title

Change in Fasting Total Cholesterol (Ratio to Baseline)

Description

Time Frame

Week 0, week 26, week 52

Title

Change in Fasting Low-density Lipoprotein (LDL) - Cholesterol (Ratio to Baseline)

Description

Time Frame

Week 0, week 26, week 52

Title

Change in Fasting High-density Lipoprotein (HDL) - Cholesterol (Ratio to Baseline)

Description

Time Frame

Week 0, week 26, week 52

Title

Change in Fasting Very-low Density Lipoprotein (VLDL) - Cholesterol (Ratio to Baseline)

Description

Time Frame

Week 0, week 26, week 52

Title

Change in Fasting Triglyceride (Ratio to Baseline)

Description

Time Frame

Week 0, week 26, week 52

Title

Participants Who Achieve HbA1c Below 7% (53 mmol/Mol), American Diabetes Association Target (Yes/No)

Description

Time Frame

Week 26, week 52

Title

Participants Who Achieve HbA1c Below or Equal to 6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists Target (Yes/No)

Description

Time Frame

Week 26, week 52

Title

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)

Description

Time Frame

Week 26, week 52

Title

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)

Description

Time Frame

Week 26, week 52

Title

Participants Who Achieve Weight Loss More Than or Equal to 5% (Yes/No).

Description

Time Frame

Week 26, week 52

Title

Participants Who Achieve Weight Loss More Than or Equal to 10% (Yes/No)

Description

Time Frame

Week 26, week 52

Title

Time to Additional Anti-diabetic Medication

Description

Time Frame

Weeks 0-52

Title

Time to Rescue Medication

Description

Time Frame

Weeks 0-52

Title

Change in Amylase (Ratio to Baseline)

Description

Time Frame

Week 0, week 26, week 52

Title

Change in Lipase (Ratio to Baseline)

Description

Time Frame

Week 0, week 26, week 52

Title

Change in Pulse Rate

Description

Time Frame

Week 0, week 26, week 52

Title

Change in Blood Pressure

Description

Time Frame

Week 0, week 26, week 52

Title

Change in ECG Evaluation

Description

Time Frame

Week 0, week 26, week 52

Title

Change in Physical Examination

Description

Time Frame

Week -2, week 26, week 52

Title

Change in Eye Examination Category

Description

Time Frame

Week -2, week 52

Title

Number of Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes

Description

Time Frame

Weeks 0-57

Title

Participants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes

Description

Time Frame

Weeks 0-57

Title

Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)

Description

Time Frame

Week 0, week 26, week 52

Title

Diabetes Therapy-Related Quality of Life (DTR-QoL): Total Score and Scores for the 4 Domains

Description

Time Frame

week 0, week 26, week 52

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Novo Nordisk Investigational Site

City

Adachi-ku, Tokyo

ZIP/Postal Code

123-0845

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Annaka-shi, Gunma

ZIP/Postal Code

379-0116

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Arakawa-ku, Tokyo

ZIP/Postal Code

116-0012

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Chiba-shi, Chiba

ZIP/Postal Code

260-0804

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Chuo-ku, Tokyo

ZIP/Postal Code

104-0061

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Fukushima

ZIP/Postal Code

963-8851

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Gunma

ZIP/Postal Code

373-0036

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Ibaraki

ZIP/Postal Code

311-0113

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Iruma-shi, Saitama

ZIP/Postal Code

358-0011

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Kanagawa

ZIP/Postal Code

232-0064

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Kashiwara-shi, Osaka

ZIP/Postal Code

582-0005

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Kawagoe-shi, Saitama

ZIP/Postal Code

350-0851

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Kawaguchi-shi, Saitama

ZIP/Postal Code

332-8558

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Kumamoto

ZIP/Postal Code

862-0976

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Kurashiki-shi, Okayama

ZIP/Postal Code

701-0192

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Kyoto-shi, Kyoto

ZIP/Postal Code

601-1495

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Mitaka-shi, Tokyo

ZIP/Postal Code

181-0013

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Mito-shi, Ibaraki

ZIP/Postal Code

310-0826

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Miyazaki

ZIP/Postal Code

880-0034

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Osaka

ZIP/Postal Code

569-1045

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Ota-ku, Tokyo

ZIP/Postal Code

144-0051

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Sapporo-shi, Hokkaido

ZIP/Postal Code

004-0004

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Sapporo-shi

ZIP/Postal Code

062 0007

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Sendai-shi, Miyagi

ZIP/Postal Code

980-0021

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Shimotsuke-shi, Tochigi

ZIP/Postal Code

329-0433

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Shinagawa-ku, Tokyo

ZIP/Postal Code

141-0032

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Shizuoka-shi, Shizuoka

ZIP/Postal Code

424-0853

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Suita-shi, Osaka

ZIP/Postal Code

565-0853

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Tokyo

ZIP/Postal Code

103-0027

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Tokyo

ZIP/Postal Code

104-0031

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Tokyo

ZIP/Postal Code

125-0054

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Tokyo

ZIP/Postal Code

160-0008

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Toshima-ku, Tokyo

ZIP/Postal Code

171-0021

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Yamato-shi, Kanagawa

ZIP/Postal Code

242-0004

Country

Japan

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

According to the Novo Nordisk disclosure commitent on novonordisk-trials.com

IPD Sharing URL

http://novonordisk-trials.com/

Citations:

PubMed Identifier

33460016

Citation

Ishii H, Hansen BB, Langer J, Horio H. 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. Diabetes Ther. 2021 Feb;12(2):613-623. doi: 10.1007/s13300-020-00985-w. Epub 2021 Jan 18.

Results Reference

result

PubMed Identifier

32333876

Citation

Yabe D, Nakamura J, Kaneto H, Deenadayalan S, Navarria A, Gislum M, Inagaki N; PIONEER 10 Investigators. 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. Lancet Diabetes Endocrinol. 2020 May;8(5):392-406. doi: 10.1016/S2213-8587(20)30074-7.

Results Reference

result

PubMed Identifier

32998732

Citation

Husain M, Bain SC, Holst AG, Mark T, Rasmussen S, Lingvay I. Effects of semaglutide on risk of cardiovascular events across a continuum of cardiovascular risk: combined post hoc analysis of the SUSTAIN and PIONEER trials. Cardiovasc Diabetol. 2020 Sep 30;19(1):156. doi: 10.1186/s12933-020-01106-4.

Results Reference

derived

PubMed Identifier

32267058

Citation

Thethi TK, Pratley R, Meier JJ. Efficacy, safety and cardiovascular outcomes of once-daily oral semaglutide in patients with type 2 diabetes: The PIONEER programme. Diabetes Obes Metab. 2020 Aug;22(8):1263-1277. doi: 10.1111/dom.14054. Epub 2020 May 13.

Results Reference

derived

PubMed Identifier

31903692

Citation

Husain M, Bain SC, Jeppesen OK, Lingvay I, Sorrig R, Treppendahl MB, Vilsboll T. Semaglutide (SUSTAIN and PIONEER) reduces cardiovascular events in type 2 diabetes across varying cardiovascular risk. Diabetes Obes Metab. 2020 Mar;22(3):442-451. doi: 10.1111/dom.13955. Epub 2020 Feb 5.

Results Reference

derived

Learn more about this trial

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

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Safety and Efficacy of Oral Semaglutide Versus Dulaglutide Both in Combination With One OAD (Oral Antidiabetic Drug) in Japanese Subjects With Type 2 Diabetes (PIONEER 10)

Diabetes, Diabetes Mellitus, Type 2

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial