Primary outcomeNumber· Weeks 0-30
Number of Treatment Emergent Adverse Events (TEAEs)
| Group | Value (Number of events) |
|---|---|
| Semaglutide 0.5 mg | 228 |
| Semaglutide 1.0 mg | 197 |
| Sitagliptin | 186 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataA Trial Comparing the Safety and Efficacy of Semaglutide Once Weekly Versus Sitagliptin Once Daily in Japanese Subjects With Type 2 Diabetes
Short name SUSTAIN™
NCTNCT02254291 (opens ClinicalTrials.gov in a new tab)Other idNN9535-4092Other idU1111-1140-5334Other idJapicCTI-142663
Overview
- Status
- Completed
- Phase
- Phase 3
- Enrollment
- 308 participants (actual)
- Sponsor
- Novo Nordisk A/S · Industry
- Design
- Randomized · Open label (no masking)
- Countries
1 country
Japan
- Start
- 2 Oct 2014
- Primary completion
- 11 Nov 2015
- Completion
- 11 Nov 2015
- First posted
- 1 Oct 2014 (estimated)
- Last update posted
- 13 Sept 2018
- Conditions
- Diabetes · Diabetes Mellitus, Type 2
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
201420152016
- Ph 3
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- semaglutideDrug
- semaglutideDrug
- sitagliptinDrug
Arms3
Experimental
Semaglutide 0.5 mg
Experimental
Semaglutide 1.0 mg
Active comparator
Sitagliptin 100 mg
Primary outcomes1
Outcomes the sponsor listed as primary.
Number of Treatment Emergent Adverse Events (TEAEs)
Time frame · Weeks 0-30
Registry description
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 outcomes(2)
Number of Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes
Time frame · Weeks 0-30
Registry 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 0-30 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)
Time frame · Week 0 and week 30
Registry description
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.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(2)
Secondary outcomeNumber· Weeks 0-30
Number of Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes
| Group | Value (Number of episodes) |
|---|---|
| Semaglutide 0.5 mg | 0 |
| Semaglutide 1.0 mg | 1 |
| Sitagliptin | 0 |
Secondary outcomeLeast squares mean· Week 0 and week 30
Change in Glycosylated Haemoglobin A1c (HbA1c)
| Group | Value (Percentage of glycosylated haemoglobin) | Spread |
|---|---|---|
| Semaglutide 0.5 mg | -1.87 | 0.07 |
| Semaglutide 1.0 mg | -2.18 | 0.07 |
| Sitagliptin | -0.74 | 0.07 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Semaglutide 0.5 mgSubjects were randomized to receive semaglutide 0.5 mg once weekly subcutaneously (s.c.; under the skin) in the thigh, abdomen, or upper arm for a duration of 30 weeks. Subjects followed a fixed dose escalation pattern to improve tolerability concerns, starting with once-weekly doses of 0.25 mg for 4 weeks (4 doses), then escalated to 0.5 mg once weekly maintenance dose for 26 weeks (maximum dose). Doses were not changed during the trial after the maintenance dose was reached. Semaglutide 1.34 mg/mL was supplied in a 1.5 mL pre-filled PDS290 pen-injector and administered on the same day of every week during the trial. For subjects previously treated with OAD monotherapy, their 8-week pre-trial OAD was washed out before randomisation. All subjects continued their pre-trial treatment of diet and exercise therapy throughout the trial. | – | 6 / 103 | 53 / 103 |
| Semaglutide 1.0 mgSubjects were randomized to receive semaglutide 1.0 mg once weekly subcutaneously (s.c.; under the skin) in the thigh, abdomen, or upper arm for a duration of 30 weeks. Subjects followed a fixed dose escalation pattern to improve tolerability concerns, starting with once-weekly doses of 0.25 mg for 4 weeks (4 doses), then escalated to 0.5 mg once weekly for 4 weeks, and finally escalated to 1.0 mg once weekly maintenance dose for 22 weeks (maximum dose). Doses were not changed during the trial after the maintenance dose was reached. Semaglutide 1.34 mg/mL was supplied in a 1.5 mL pre-filled PDS290 pen-injector and administered on the same day of every week during the trial. For subjects previously treated with OAD monotherapy, their 8-week pre-trial OAD was washed out before randomisation. All subjects continued their pre-trial treatment of diet and exercise therapy throughout the trial. | – | 2 / 102 | 46 / 102 |
| SitagliptinThe subjects in this arm received oral fixed dose of sitagliptin 100 mg tablet once daily for a duration of 30 weeks. For subjects previously treated with OAD monotherapy, their pre-trial OAD was washed out before randomisation. Doses of sitagliptin were not changed throughout the trial. All subjects continued their pre-trial treatment of diet and exercise therapy throughout the trial. | – | 2 / 103 | 36 / 103 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies2
Studies that cite this trial.
Studies with results
1 study on this page
Indexing hint: Randomized controlled trial · 2018
11 results
Safety and efficacy of semaglutide once weekly vs sitagliptin once daily, both as monotherapy in Japanese people with type 2 diabetes.
Seino et al. 2018Diabetes, obesity & metabolismcited by 97
PMID 28786547PMC5813234DOI 10.1111/dom.13082PUB-28786547
Free to read · publisher termsCC BY-NC11 results
More studies
1 study on this page
PubMed tag: none · 2020
Effects of semaglutide on risk of cardiovascular events across a continuum of cardiovascular risk: combined post hoc analysis of the SUSTAIN and PIONEER trials.
Husain et al. 2020Cardiovascular diabetologycited by 33
PMID 32998732PMC7526237DOI 10.1186/s12933-020-01106-4PUB-32998732
CC BY
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 20 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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
PepBank is a research reference. Talk to a doctor before you use any peptide.