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A Trial Comparing the Safety and Efficacy of Semaglutide Once Weekly Versus Sitagliptin Once Daily in Japanese Subjects With Type 2 Diabetes (SUSTAIN™)

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: NCT02254291
Recruitment Status : Completed
First Posted : October 1, 2014
Results First Posted : September 13, 2018
Last Update Posted : September 13, 2018
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This trial is conducted in Japan. The purpose is to compare the safety of once-weekly dosing of semaglutide (0.5 and 1.0 mg) versus sitagliptin (100 mg) once daily, both as monotherapy during 30 weeks of treatment in Japanese subjects with type 2 diabetes.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Drug: semaglutide Drug: sitagliptin Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 308 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Semaglutide Once Weekly Versus Sitagliptin Once Daily, Both as Monotherapy in Japanese Subjects With Type 2 Diabetes
Actual Study Start Date : October 2, 2014
Actual Primary Completion Date : November 11, 2015
Actual Study Completion Date : November 11, 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Semaglutide 0.5 mg Drug: semaglutide
Once weekly doses of 0.5 mg semaglutide after an initial dose escalation step of 0.25 mg (4 weeks). Total duration of treatment is 30 weeks. Administered subcutaneously (s.c. under the skin).

Experimental: Semaglutide 1.0 mg Drug: semaglutide
Once weekly doses of 1.0 mg semaglutide after an initial dose escalation step of 0.25 mg (4 weeks) followed by 0.5 mg for 4 weeks. Total duration of treatment is 30 weeks. Administered subcutaneously (s.c. under the skin).

Active Comparator: Sitagliptin 100 mg Drug: sitagliptin
Daily doses of 100 mg sitagliptin. Total duration of treatment is 30 weeks. Administered as oral tablets.




Primary Outcome Measures :
  1. Number of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Weeks 0-30 ]
    An adverse events (AEs) was defined as any unfavourable 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 0-30 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 0-30 ]
    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 0-30 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 and week 30 ]
    Mean changes in HbA1c values from baseline after 30 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.



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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 20 years or older at the time of signing informed consent
  • Glycated hemoglobin (HbA1c) between 6.5% and 9.5% (48-80 mmol/mol) (both inclusive) for subjects treated with oral antidiabetic drug (OAD) monotherapy and between 7.0% and 10.5% (53-91 mmol/mol) (both inclusive) for subjects treated with diet and exercise therapy at screening
  • Japanese subjects diagnosed with type 2 diabetes who are: a) on stable OAD monotherapy at a half-maximum dose or below according to the approved Japanese labelling in addition to diet and exercise therapy for at least 30 days prior to screening (week -8) (For metformin only: the maximum dose of 750 mg/day is allowed except for METGLUCO®. For METGLUCO®, the allowable half-max dose of 1125 mg/day must be applied.). 'Stable' is defined as unchanged medication and unchanged dose, or b) on stable diet and exercise therapy for at least 30 days prior to screening (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, diaphragm, condom [by the partner], intrauterine device, sponge, spermicide or oral contraceptives) throughout the trial including the 5-week follow-up period
  • Treatment with once-weekly glucagon-like peptide-1 (GLP-1) receptor agonists within 90 days prior to screening
  • Treatment with any glucose lowering agent(s) (except for pre-trial OAD for subject treated with OAD monotherapy) in a period of 60 days prior to screening. An exception is short-term treatment (7 days or less 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 of 50 ng/L (pg/mL) or greater
  • 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) less than 60 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
  • Heart failure, New York Heart Association (NYHA) class IV

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): NCT02254291


Locations
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Japan
Novo Nordisk Investigational Site
Asahikawa-shi, Hokkaido, Japan, 070 0002
Novo Nordisk Investigational Site
Chitose, Hokkaido, Japan, 066-0032
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
Ebina-shi, Japan, 243 0432
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
Kumamoto-shi,Kumamoto, Japan, 862 0976
Novo Nordisk Investigational Site
Naka-shi, Ibaraki, Japan, 311 0113
Novo Nordisk Investigational Site
Nishinomiya-shi, Hygo, Japan, 662 0971
Novo Nordisk Investigational Site
Oita-shi, Japan, 870 0039
Novo Nordisk Investigational Site
Osaka-shi, Osaka, Japan, 553 0003
Novo Nordisk Investigational Site
Ota-ku, Tokyo, Japan, 144 0035
Novo Nordisk Investigational Site
Ota-ku, Tokyo, Japan
Novo Nordisk Investigational Site
Sapporo-shi, Hokkaido, Japan, 060 0062
Novo Nordisk Investigational Site
Sapporo-shi, Hokkaido, Japan, 060-0001
Novo Nordisk Investigational Site
Shimotsuke-shi, Tochigi, Japan, 329 0433
Novo Nordisk Investigational Site
Shinjuku-ku, Tokyo, Japan, 160-0008
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, 181-0013
Novo Nordisk Investigational Site
Yokohama, Kanagawa, Japan, 236-0004
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
Additional Information:
Publications of Results:
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT02254291    
Other Study ID Numbers: NN9535-4092
U1111-1140-5334 ( Other Identifier: WHO )
JapicCTI-142663 ( Registry Identifier: JAPIC )
First Posted: October 1, 2014    Key Record Dates
Results First Posted: September 13, 2018
Last Update Posted: September 13, 2018
Last Verified: December 2017
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action