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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™)

Primary Purpose

Diabetes, Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
semaglutide
DPP-4 inhibitor
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Semaglutide 0.5 mg

Semaglutide 1.0 mg

One additional OAD + pre-trial treatment

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of Treatment Emergent Adverse Events (TEAEs)
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

Number of Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes
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).
Change in Glycosylated Haemoglobin A1c (HbA1c)
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.

Full Information

First Posted
August 1, 2014
Last Updated
June 21, 2018
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT02207374
Brief Title
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
Acronym
SUSTAIN™
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
August 4, 2014 (Actual)
Primary Completion Date
February 27, 2016 (Actual)
Study Completion Date
February 27, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
601 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Semaglutide 0.5 mg
Arm Type
Experimental
Arm Title
Semaglutide 1.0 mg
Arm Type
Experimental
Arm Title
One additional OAD + pre-trial treatment
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
semaglutide
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
DPP-4 inhibitor
Intervention Description
Subjects will receive one DPP-4 inhibitor in addition to pre-trial OAD monotherapy, if any, for 56 weeks.
Primary Outcome Measure Information:
Title
Number of Treatment Emergent Adverse Events (TEAEs)
Description
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).
Time Frame
Weeks 0-56
Secondary Outcome Measure Information:
Title
Number of Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes
Description
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).
Time Frame
Weeks 0-56
Title
Change in Glycosylated Haemoglobin A1c (HbA1c)
Description
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.
Time Frame
Week 0, week 56

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Akita-shi, Akita
ZIP/Postal Code
010 8543
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Annaka-shi, Gunma
ZIP/Postal Code
379 0116
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Asahikawa-shi, Hokkaido
ZIP/Postal Code
070 0002
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Asahikawa-shi, Hokkaido
ZIP/Postal Code
078 8510
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Bunkyo-ku, Tokyo
ZIP/Postal Code
113 8431
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Chuo-ku Tokyo
ZIP/Postal Code
103-0027
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Chuo-ku Tokyo
ZIP/Postal Code
104-0031
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Chuo-ku, Tokyo
ZIP/Postal Code
103 0002
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Chuo-ku, Tokyo
ZIP/Postal Code
103 0027
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Chuo-ku, Tokyo
ZIP/Postal Code
104-0061
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Fukuoka
ZIP/Postal Code
812 0025
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Higashiosaka-shi, Osaka
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Izumisano-shi
ZIP/Postal Code
598 0048
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Kashiwara-shi, Osaka
ZIP/Postal Code
582 0005
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Katsushika-ku, Tokyo
ZIP/Postal Code
125 0054
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Kitakyushu-shi, Fukuoka
ZIP/Postal Code
800 0252
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Koriyama-shi, Fukushima
ZIP/Postal Code
963 8851
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Kumamoto-shi,Kumamoto
ZIP/Postal Code
862 0976
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Kyoto-shi, Kyoto
ZIP/Postal Code
615 8125
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Mito-shi, Ibaraki
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Miyazaki-shi
ZIP/Postal Code
880 0034
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Naka-shi, Ibaraki
ZIP/Postal Code
311 0113
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Nishinomiya-shi, Hygo
ZIP/Postal Code
662 0971
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Nishinomiya-shi, Hyogo
ZIP/Postal Code
663-8501
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Okawa-shi, Fukuoka
ZIP/Postal Code
831 0016
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Okayama-shi, Okayama
ZIP/Postal Code
700 8505
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Osaka-shi, Osaka
ZIP/Postal Code
532 0003
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Ota-ku, Tokyo
ZIP/Postal Code
144 0035
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Ota-ku, Tokyo
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Oyama-shi, Tochigi
ZIP/Postal Code
323 0022
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Saga-shi,Saga
ZIP/Postal Code
849 0937
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Sapporo-shi, Hokkaido
ZIP/Postal Code
060 0062
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Sapporo-shi, Hokkaido
ZIP/Postal Code
062 0007
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Sendai-shi
ZIP/Postal Code
980 0021
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Shimotsuke-shi, Tochigi
ZIP/Postal Code
329 0433
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Shinjuku-ku, Tokyo
ZIP/Postal Code
160-0008
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Shizuoka-shi
ZIP/Postal Code
424 0853
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Suita-shi, Osaka
ZIP/Postal Code
565-0853
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Takatsuki-shi, Osaka
ZIP/Postal Code
569 1096
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Tokyo
ZIP/Postal Code
103-0028
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Tokyo
ZIP/Postal Code
123-0845
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Ube-shi, Yamaguchi
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Yokohama-shi
ZIP/Postal Code
235 0045
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
29322610
Citation
Kaku K, Yamada Y, Watada H, Abiko A, Nishida T, Zacho J, Kiyosue A. Safety and efficacy of once-weekly semaglutide vs additional oral antidiabetic drugs in Japanese people with inadequately controlled type 2 diabetes: A randomized trial. Diabetes Obes Metab. 2018 May;20(5):1202-1212. doi: 10.1111/dom.13218. Epub 2018 Feb 21.
Results Reference
result
PubMed Identifier
29748996
Citation
Petri KCC, Ingwersen SH, Flint A, Zacho J, Overgaard RV. Exposure-response analysis for evaluation of semaglutide dose levels in type 2 diabetes. Diabetes Obes Metab. 2018 Sep;20(9):2238-2245. doi: 10.1111/dom.13358. Epub 2018 Jun 15.
Results Reference
result
PubMed Identifier
29907893
Citation
Carlsson Petri KC, Ingwersen SH, Flint A, Zacho J, Overgaard RV. Semaglutide s.c. Once-Weekly in Type 2 Diabetes: A Population Pharmacokinetic Analysis. Diabetes Ther. 2018 Aug;9(4):1533-1547. doi: 10.1007/s13300-018-0458-5. Epub 2018 Jun 15.
Results Reference
result
PubMed Identifier
32998732
Citation
Husain M, Bain SC, Holst AG, Mark T, Rasmussen S, Lingvay I. Effects of semaglutide on risk of cardiovascular events across a continuum of cardiovascular risk: combined post hoc analysis of the SUSTAIN and PIONEER trials. Cardiovasc Diabetol. 2020 Sep 30;19(1):156. doi: 10.1186/s12933-020-01106-4.
Results Reference
derived
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

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

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