A Trial Comparing the Safety and Efficacy of Semaglutide Once Weekly in Monotherapy or in Combination With One OAD in Japanese Subjects With Type 2 Diabetes (SUSTAIN™)

June 21, 2018 updated by: Novo Nordisk A/S

Safety and Efficacy of Semaglutide Once Weekly in Monotherapy or in Combination With One OAD in Japanese Subjects With Type 2 Diabetes Who Are Insufficiently Controlled on Diet/Exercise Therapy or OAD Monotherapy

This trial is conducted in Asia. The aim of the trial is to investigate safety and efficacy of semaglutide once weekly in monotherapy or in combination with one OAD (oral anti-diabetic drug) in Japanese subjects with type 2 diabetes who are insufficiently controlled on diet/exercise therapy or OAD monotherapy.

All subjects will continue their pre-trial treatment (diet and exercise therapy or OAD monotherapy in addition to diet and exercise therapy) during the trial.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

601

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Akita-shi, Akita, Japan, 010 8543
        • Novo Nordisk Investigational Site
      • Annaka-shi, Gunma, Japan, 379 0116
        • Novo Nordisk Investigational Site
      • Asahikawa-shi, Hokkaido, Japan, 070 0002
        • Novo Nordisk Investigational Site
      • Asahikawa-shi, Hokkaido, Japan, 078 8510
        • Novo Nordisk Investigational Site
      • Bunkyo-ku, Tokyo, Japan, 113 8431
        • Novo Nordisk Investigational Site
      • Chuo-ku Tokyo, Japan, 103-0027
        • Novo Nordisk Investigational Site
      • Chuo-ku Tokyo, Japan, 104-0031
        • Novo Nordisk Investigational Site
      • Chuo-ku, Tokyo, Japan, 103 0027
        • Novo Nordisk Investigational Site
      • Chuo-ku, Tokyo, Japan, 103 0002
        • Novo Nordisk Investigational Site
      • Chuo-ku, Tokyo, Japan, 104-0061
        • Novo Nordisk Investigational Site
      • Fukuoka, Japan, 812 0025
        • Novo Nordisk Investigational Site
      • Higashiosaka-shi, Osaka, Japan
        • Novo Nordisk Investigational Site
      • Izumisano-shi, Japan, 598 0048
        • Novo Nordisk Investigational Site
      • Kashiwara-shi, Osaka, Japan, 582 0005
        • Novo Nordisk Investigational Site
      • Katsushika-ku, Tokyo, Japan, 125 0054
        • Novo Nordisk Investigational Site
      • Kitakyushu-shi, Fukuoka, Japan, 800 0252
        • Novo Nordisk Investigational Site
      • Koriyama-shi, Fukushima, Japan, 963 8851
        • Novo Nordisk Investigational Site
      • Kumamoto-shi,Kumamoto, Japan, 862 0976
        • Novo Nordisk Investigational Site
      • Kyoto-shi, Kyoto, Japan, 615 8125
        • Novo Nordisk Investigational Site
      • Mito-shi, Ibaraki, Japan
        • Novo Nordisk Investigational Site
      • Miyazaki-shi, Japan, 880 0034
        • Novo Nordisk Investigational Site
      • Naka-shi, Ibaraki, Japan, 311 0113
        • Novo Nordisk Investigational Site
      • Nishinomiya-shi, Hygo, Japan, 662 0971
        • Novo Nordisk Investigational Site
      • Nishinomiya-shi, Hyogo, Japan, 663-8501
        • Novo Nordisk Investigational Site
      • Okawa-shi, Fukuoka, Japan, 831 0016
        • Novo Nordisk Investigational Site
      • Okayama-shi, Okayama, Japan, 700 8505
        • Novo Nordisk Investigational Site
      • Osaka-shi, Osaka, Japan, 532 0003
        • Novo Nordisk Investigational Site
      • Ota-ku, Tokyo, Japan, 144 0035
        • Novo Nordisk Investigational Site
      • Ota-ku, Tokyo, Japan
        • Novo Nordisk Investigational Site
      • Oyama-shi, Tochigi, Japan, 323 0022
        • Novo Nordisk Investigational Site
      • Saga-shi,Saga, Japan, 849 0937
        • Novo Nordisk Investigational Site
      • Sapporo-shi, Hokkaido, Japan, 060 0062
        • Novo Nordisk Investigational Site
      • Sapporo-shi, Hokkaido, Japan, 062 0007
        • Novo Nordisk Investigational Site
      • Sendai-shi, Japan, 980 0021
        • Novo Nordisk Investigational Site
      • Shimotsuke-shi, Tochigi, Japan, 329 0433
        • Novo Nordisk Investigational Site
      • Shinjuku-ku, Tokyo, Japan, 160-0008
        • Novo Nordisk Investigational Site
      • Shizuoka-shi, Japan, 424 0853
        • Novo Nordisk Investigational Site
      • Suita-shi, Osaka, Japan, 565-0853
        • Novo Nordisk Investigational Site
      • Takatsuki-shi, Osaka, Japan, 569 1096
        • Novo Nordisk Investigational Site
      • Tokyo, Japan, 103-0028
        • Novo Nordisk Investigational Site
      • Tokyo, Japan, 123-0845
        • Novo Nordisk Investigational Site
      • Ube-shi, Yamaguchi, Japan
        • Novo Nordisk Investigational Site
      • Yokohama-shi, Japan, 235 0045
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female, age at least 20 years at the time of signing informed consent
  • HbA1c (glycosylated haemoglobin A1c) between 7.0% and 10.5% (53-91 mmol/mol) (both inclusive)
  • Japanese subjects with type 2 diabetes mellitus (diagnosed clinically) and on stable treatment (defined as unchanged medication and unchanged dose) who are: a) on diet and exercise therapy for at least 30 days before Visit 1 (week -2). or b) on OAD monotherapy (either of SU (sulfonylurea), glinide, a-GI (a-glucosidase inhibitor) or TZD (thiazolidinediones)) within approved Japanese labelling in addition to diet and exercise therapy for at least 60 days before Visit 1 (week -2)

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 (e.g., abstinence [not having sex], diaphragm, condom [by the partner], intrauterine device, sponge, spermicide or oral contraceptives) throughout the trial including the 5 week follow-up period
  • Treatment with glucose lowering agent(s) other than stated in the inclusion criteria within 60 days before Visit 1 (week -2) and treatment with once weekly glucagon-like peptide-1 (GLP-1) receptor agonists within 90 days before Visit 1 (week -2). An exception is short-term treatment (below or equal to 7 days in total) with insulin in connection with inter-current illness
  • Any disorder which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol
  • History of chronic or idiopathic acute pancreatitis
  • Screening calcitonin value above or equal to 50 ng/L (pg/mL)
  • Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2)
  • Impaired renal function defined as estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m^2 per modification of diet in renal disease (MDRD) formula (4 variable version)
  • Acute coronary or cerebrovascular event within 90 days before randomisation (Visit 2 [week 0])
  • Heart failure, New York Heart Association (NYHA) class IV

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Semaglutide 0.5 mg
Drug: semaglutide
Subject will receive either a dose of 0.5 or 1.0 mg of semaglutide once weekly (subcutaneous (s.c.) injection).Treatment duration 56 weeks.
Experimental: Semaglutide 1.0 mg
Drug: semaglutide
Subject will receive either a dose of 0.5 or 1.0 mg of semaglutide once weekly (subcutaneous (s.c.) injection).Treatment duration 56 weeks.
Active Comparator: One additional OAD + pre-trial treatment
The type and dosage of the additional OAD will be selected by the investigators according to the approved Japanese labelling including drug combinations and contraindications. One of DPP-4 inhibitor (dipeptidyl peptidase-4), SU (sulfonylurea), glinide, biguanide, α-GI (α-glucosidase inhibitor)or TZD (thiazolidinediones) will be selected as the additional OAD. For the subjects treated with OAD monotherapy as pre-trial treatment, the type and dosage of the additional OAD with a different mechanism of action from the pre-trial OAD should be chosen.
Drug: DPP-4 inhibitor
Subjects will receive one DPP-4 inhibitor in addition to pre-trial OAD monotherapy, if any, for 56 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Treatment Emergent Adverse Events (TEAEs)
Time Frame: Weeks 0-56
An adverse event (AEs) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. All AEs mentioned here are treatment emergent adverse events (TEAE) defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment (week 0-56 treatment period) and no later than the follow-up visit during the on-treatment observation period (date of last dose + 42 days).
Weeks 0-56

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes
Time Frame: Weeks 0-56
Severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe and/or BG confirmed by a plasma glucose value of <56 mg/dL (3.1 mmol/L), with symptoms consistent with hypoglycaemia. Severe hypoglycaemia: was an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. The episodes mentioned here are treatment emergent hypoglycaemic episodes and defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment (week 0-56 treatment period) and no later than the follow-up visit during the on-treatment observation period (date of last dose + 42 days).
Weeks 0-56
Change in Glycosylated Haemoglobin A1c (HbA1c)
Time Frame: Week 0, week 56
The observed mean change in HbA1c values from baseline after 56 weeks of treatment. Changes in HbA1c were analysed using a mixed model for repeated measurements (MMRM) with treatment and pre-trial treatment at screening as fixed factors and baseline value as covariate. The data were analysed for the "on-treatment without rescue medication" observation period which includes observations noted at or after the date of first dose of randomised treatment and not after the last dose of the trial product (+ a 7-day visit window) or initiation of rescue medication.
Week 0, week 56

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 4, 2014

Primary Completion (Actual)

February 27, 2016

Study Completion (Actual)

February 27, 2016

Study Registration Dates

First Submitted

August 1, 2014

First Submitted That Met QC Criteria

August 1, 2014

First Posted (Estimate)

August 4, 2014

Study Record Updates

Last Update Posted (Actual)

January 7, 2019

Last Update Submitted That Met QC Criteria

June 21, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN9535-4091
  • U1111-1140-3081 (Other Identifier: WHO)
  • JapicCTI-142640 (Registry Identifier: JAPIC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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