Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03015220
Recruitment Status : Completed
First Posted : January 9, 2017
Last Update Posted : July 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 Safety and efficacy of oral semaglutide versus dulaglutide both in combination with one OAD (oral antidiabetic drug) in Japanese subjects with type 2 diabetes.

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 458 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Oral Semaglutide Versus Dulaglutide Both in Combination With One OAD in Japanese Subjects With Type 2 Diabetes
Actual Study Start Date : January 10, 2017
Actual Primary Completion Date : July 12, 2018
Actual Study Completion Date : July 12, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Oral semaglutide 3 mg Drug: Semaglutide
Oral administration once-daily, as add-on to pre-trial oral antidiabetic drug (OAD).

Experimental: Oral semaglutide 7 mg Drug: Semaglutide
Oral administration once-daily, as add-on to pre-trial oral antidiabetic drug (OAD).

Experimental: Oral semaglutide 14 mg Drug: Semaglutide
Oral administration once-daily, as add-on to pre-trial oral antidiabetic drug (OAD).

Active Comparator: Dulaglutide 0.75 mg Drug: Dulaglutide
Subcutaneously administration (s.c., under the skin) once-weekly, as add-on to pre-trial oral antidiabetic drug (OAD).




Primary Outcome Measures :
  1. Number of treatment-emergent adverse events [ Time Frame: Week 0 - 57 ]

Secondary Outcome Measures :
  1. Number of treatment-emergent severe or blood glucose-confirmed symptomatic hypoglycaemic episodes [ Time Frame: Week 0 - 57 ]
  2. Change in HbA1c [ Time Frame: Week 0, week 26, week 52 ]
  3. Change in Body weight (kg) [ Time Frame: Week 0, week 26, week 52 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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 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

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): NCT03015220


Locations
Layout table for location information
Japan
Novo Nordisk Investigational Site
Adachi-ku, Tokyo, Japan, 123-0845
Novo Nordisk Investigational Site
Annaka-shi, Gunma, Japan, 379-0116
Novo Nordisk Investigational Site
Arakawa-ku, Tokyo, Japan, 116-0012
Novo Nordisk Investigational Site
Chiba-shi, Chiba, Japan, 260-0804
Novo Nordisk Investigational Site
Chuo-ku, Tokyo, Japan, 104-0061
Novo Nordisk Investigational Site
Fukushima, Japan, 963-8851
Novo Nordisk Investigational Site
Gunma, Japan, 373-0036
Novo Nordisk Investigational Site
Ibaraki, Japan, 311-0113
Novo Nordisk Investigational Site
Iruma-shi, Saitama, Japan, 358-0011
Novo Nordisk Investigational Site
Kanagawa, Japan, 232-0064
Novo Nordisk Investigational Site
Kashiwara-shi, Osaka, Japan, 582-0005
Novo Nordisk Investigational Site
Kawagoe-shi, Saitama, Japan, 350-0851
Novo Nordisk Investigational Site
Kawaguchi-shi, Saitama, Japan, 332-8558
Novo Nordisk Investigational Site
Kumamoto, Japan, 862-0976
Novo Nordisk Investigational Site
Kurashiki-shi, Okayama, Japan, 701-0192
Novo Nordisk Investigational Site
Kyoto-shi, Kyoto, Japan, 601-1495
Novo Nordisk Investigational Site
Mitaka-shi, Tokyo, Japan, 181-0013
Novo Nordisk Investigational Site
Mito-shi, Ibaraki, Japan, 310-0826
Novo Nordisk Investigational Site
Miyazaki, Japan, 880-0034
Novo Nordisk Investigational Site
Osaka, Japan, 569-1045
Novo Nordisk Investigational Site
Ota-ku, Tokyo, Japan, 144-0051
Novo Nordisk Investigational Site
Sapporo-shi, Hokkaido, Japan, 004-0004
Novo Nordisk Investigational Site
Sapporo-shi, Japan, 062 0007
Novo Nordisk Investigational Site
Sendai-shi, Miyagi, Japan, 980-0021
Novo Nordisk Investigational Site
Shimotsuke-shi, Tochigi, Japan, 329-0433
Novo Nordisk Investigational Site
Shinagawa-ku, Tokyo, Japan, 141-0032
Novo Nordisk Investigational Site
Shizuoka-shi, Shizuoka, Japan, 424-0853
Novo Nordisk Investigational Site
Suita-shi, Osaka, Japan, 565-0853
Novo Nordisk Investigational Site
Tokyo, Japan, 103-0027
Novo Nordisk Investigational Site
Tokyo, Japan, 125-0054
Novo Nordisk Investigational Site
Tokyo, Japan, 160-0008
Novo Nordisk Investigational Site
Toshima-ku, Tokyo, Japan, 171-0021
Novo Nordisk Investigational Site
Yamato-shi, Kanagawa, Japan, 242-0004
Sponsors and Collaborators
Novo Nordisk A/S

Layout table for additonal information
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT03015220     History of Changes
Other Study ID Numbers: NN9924-4282
U1111-1181-4133 ( Other Identifier: WHO )
JapicCTI-173485 ( Other Identifier: Japic )
First Posted: January 9, 2017    Key Record Dates
Last Update Posted: July 15, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitent on novonordisk-trials.com
URL: http://novonordisk-trials.com/

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Dulaglutide
Hypoglycemic Agents
Immunoglobulin Fc Fragments
Physiological Effects of Drugs
Immunologic Factors