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

• Register: ClinicalTrials.gov
• Last refreshed on: 25 January 2021
• Main ID: NCT03015220
• Date of registration: 06/01/2017
• Prospective Registration: Yes
• Primary sponsor: Novo Nordisk A/S
• Public 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 PIONEER 10
• Scientific title: Safety and Efficacy of Oral Semaglutide Versus Dulaglutide Both in Combination With One OAD in Japanese Subjects With Type 2 Diabetes
• Date of first enrolment: January 10, 2017
• Target sample size: 458
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03015220
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Japan

Key inclusion & exclusion 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), a-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, a-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



Age minimum: 20 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Diabetes Mellitus, Type 2

Diabetes

Intervention(s)

Drug: Dulaglutide

Drug: Semaglutide

Primary Outcome(s)

Number of Treatment-emergent Adverse Events (TEAEs) [Time Frame: Weeks 0-57]

Secondary Outcome(s)

Number of Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes [Time Frame: Weeks 0-57]

Participants Who Achieve Weight Loss More Than or Equal to 10% (Yes/No) [Time Frame: Week 26, week 52]

Time to Rescue Medication [Time Frame: Weeks 0-52]

Change in Amylase (Ratio to Baseline) [Time Frame: Week 0, week 26, week 52]

Change in Body Weight (%) [Time Frame: Week 0, week 26, week 52]

Change in Eye Examination Category [Time Frame: Week -2, week 52]

Change in HbA1c [Time Frame: Week 0, week 26, week 52]

Change in Pulse Rate [Time Frame: Week 0, week 26, week 52]

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]

Participants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes [Time Frame: Weeks 0-57]

Change in Fasting Plasma Glucose [Time Frame: Week 0, week 26, week 52]

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) [Time Frame: Week 0, week 26, week 52]

Change in Body Mass Index (BMI) [Time Frame: Week 0, week 26, week 52]

Change in Physical Examination [Time Frame: Week -2, week 26, week 52]

Change in Blood Pressure [Time Frame: Week 0, week 26, week 52]

Change in Body Weight (kg) [Time Frame: Week 0, week 26, week 52]

Diabetes Therapy-Related Quality of Life (DTR-QoL): Total Score and Scores for the 4 Domains [Time Frame: week 0, week 26, week 52]

Participants Who Achieve HbA1c Below 7% (53 mmol/Mol), American Diabetes Association Target (Yes/No) [Time Frame: Week 26, week 52]

Change in Fasting Triglyceride (Ratio to Baseline) [Time Frame: Week 0, week 26, week 52]

Change in Waist Circumference [Time Frame: Week 0, week 26, week 52]

Change in ECG Evaluation [Time Frame: Week 0, week 26, week 52]

Change in Fasting High-density Lipoprotein (HDL) - Cholesterol (Ratio to Baseline) [Time Frame: Week 0, week 26, week 52]

Change in Fasting Low-density Lipoprotein (LDL) - Cholesterol (Ratio to Baseline) [Time Frame: Week 0, week 26, week 52]

Change in Lipase (Ratio to Baseline) [Time Frame: Week 0, week 26, week 52]

Change in Self-measured Plasma Glucose 7-point Profile (SMPG) - Mean 7-point Profile [Time Frame: Week 0, week 26, week 52]

Time to Additional Anti-diabetic Medication [Time Frame: Weeks 0-52]

Change in Fasting Total Cholesterol (Ratio to Baseline) [Time Frame: Week 0, week 26, week 52]

Change in Fasting Very-low Density Lipoprotein (VLDL) - Cholesterol (Ratio to Baseline) [Time Frame: Week 0, week 26, week 52]

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]

Change in Self-measured Plasma Glucose (SMPG) - Mean Postprandial Increment Over All Meals [Time Frame: Week 0, week 26, week 52]

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]

Participants Who Achieve Weight Loss More Than or Equal to 5% (Yes/No). [Time Frame: Week 26, week 52]

Secondary ID(s)

NN9924-4282

U1111-1181-4133

JapicCTI-173485

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 30/12/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03015220