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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™)

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ClinicalTrials.gov Identifier: NCT02207374
Recruitment Status : Completed
First Posted : August 4, 2014
Results First Posted : January 7, 2019
Last Update Posted : January 7, 2019
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Drug: semaglutide Drug: DPP-4 inhibitor Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 601 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 4, 2014
Actual Primary Completion Date : February 27, 2016
Actual Study Completion Date : February 27, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Semaglutide

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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).

  2. 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.


Eligibility Criteria
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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:

  • 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
Contacts and Locations
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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): NCT02207374


Locations
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Japan
Novo Nordisk Investigational Site
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 0002
Novo Nordisk Investigational Site
Chuo-ku, Tokyo, Japan, 103 0027
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
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information
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Additional Information:

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT02207374    
Other Study ID Numbers: NN9535-4091
U1111-1140-3081 ( Other Identifier: WHO )
JapicCTI-142640 ( Registry Identifier: JAPIC )
First Posted: August 4, 2014    Key Record Dates
Results First Posted: January 7, 2019
Last Update Posted: January 7, 2019
Last Verified: June 2018
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Dipeptidyl-Peptidase IV Inhibitors
 Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs