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Dose-response, Safety and Efficacy of Oral Semaglutide Versus Placebo and Versus Liraglutide, All as Monotherapy in Japanese Subjects With Type 2 Diabetes (PIONEER 9)

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ClinicalTrials.gov Identifier: NCT03018028
Recruitment Status : Completed
First Posted : January 11, 2017
Last Update Posted : May 15, 2019
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This trial is conducted in Asia. The aim of this trial is to investigate the dose-response relationship of once-daily dosing of three dose levels (3, 7 and 14 mg) of oral semaglutide versus placebo as monotherapy on glycaemic control in Japanese subjects with type 2 diabetes mellitus

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Drug: Semaglutide Drug: Placebo Drug: Liraglutide Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 243 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Dose-response, Safety and Efficacy of Oral Semaglutide Versus Placebo and Versus Liraglutide, All as Monotherapy in Japanese Subjects With Type 2 Diabetes
Actual Study Start Date : January 10, 2017
Actual Primary Completion Date : January 9, 2018
Actual Study Completion Date : August 15, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Oral semaglutide 3 mg Drug: Semaglutide
Oral administration once daily

Experimental: Oral semaglutide 7 mg Drug: Semaglutide
Oral administration once daily

Experimental: Oral semaglutide 14 mg Drug: Semaglutide
Oral administration once daily

Placebo Comparator: Oral placebo Drug: Placebo
Oral administration once daily

Active Comparator: Liraglutide 0.9 mg Drug: Liraglutide
Subcutaneous (s.c., under the skin) injection once daily




Primary Outcome Measures :
  1. Change in HbA1c [ Time Frame: week 0, week 26 ]

Secondary Outcome Measures :
  1. Change in HbA1c [ Time Frame: Week 0, week 52 ]
  2. Change in Fasting plasma glucose [ Time Frame: week 0, week 26, week 52 ]
  3. Change in Body weight (kg) [ Time Frame: week 0, week 26, week 52 ]
  4. Number of subjects achieving Yes/No in level of glycosylated haemoglobin (HbA1c) below 7% (53 mmol/mol) [ Time Frame: After week 26 and week 52 ]
    (American Diabetes Association [ADA] target)



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 30 days prior to day of screening
  • HbA1c 6.5%−9.5% (48−80 mmol/mol) (both inclusive) for subjects treated with oral antidiabetic drug as monotherapy and 7.0%−10.0% (53−86 mmol/mol) (both inclusive) for subjects treated with diet and exercise therapy alone
  • Treatment for at least 30 days prior to day of screening with;- stable daily dose of oral anti-diabetic drug as monotherapy (allowed oral anti-diabetic drugs are: metformin, sulphonylurea, glinide, α-glucosidase inhibitor, dipeptidyl peptidase-4 inhibitor and sodium-glucose cotransporter-2 inhibitor) at a half-maximum approved dose or below according to Japanese labelling in addition to diet and exercise therapy. or - diet and exercise therapy alone

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 and 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 within the past 180 days prior to the day of screening and randomisation
  • Subject 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 agonist (GLP-1 RA), once weekly dipeptidyl peptidase-4 (DPP-4) inhibitor or thiazolidinedione in a period of 90 days before the day of screening
  • Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 60 days before the day of screening. An exception is short-term insulin treatment for acute illness for a total of below or equal to 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)
  • Initiation of anti-diabetic medication between the day of screening and the day of randomisation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03018028


Locations
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Japan
Novo Nordisk Investigational Site
Akita-shi, Akita, Japan, 010-8543
Novo Nordisk Investigational Site
Arakawa-ku, Tokyo, Japan, 116-0012
Novo Nordisk Investigational Site
Ebina-shi, Kanagawa, Japan, 243-0432
Novo Nordisk Investigational Site
Gunma, Japan, 373-0036
Novo Nordisk Investigational Site
Kanagawa, Japan, 232-0064
Novo Nordisk Investigational Site
Minato-ku, Tokyo, Japan, 108-0075
Novo Nordisk Investigational Site
Naka-shi, Japan, 311 0113
Novo Nordisk Investigational Site
Osaka-shi, Osaka, Japan, 553-0003
Novo Nordisk Investigational Site
Ota-ku, Tokyo, Japan, 144-0051
Novo Nordisk Investigational Site
Saga-shi, Saga, Japan, 849-0937
Novo Nordisk Investigational Site
Sendai-shi, Miyagi, Japan, 980-8574
Novo Nordisk Investigational Site
Suita-shi, Osaka, Japan, 565-0853
Novo Nordisk Investigational Site
Tokyo, Japan, 103-0027
Novo Nordisk Investigational Site
Tokyo, Japan, 103-0028
Novo Nordisk Investigational Site
Tokyo, Japan, 160-0008
Sponsors and Collaborators
Novo Nordisk A/S

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT03018028     History of Changes
Other Study ID Numbers: NN9924-4281
U1111-1181-4048 ( Other Identifier: WHO )
JapicCTI-173489 ( Other Identifier: JAPIC )
First Posted: January 11, 2017    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists