What SUSTAIN measured first
| Semaglutide 0.5 mgn=103 | Semaglutide 1.0 mgn=102 | Sitagliptinn=103 |
|---|---|---|
| 228 | 197 | 186 |
Safety and Efficacy of Semaglutide Once Weekly Versus Sitagliptin Once Daily, Both as Monotherapy in Japanese Subjects With Type 2 Diabetes
Number of Treatment Emergent Adverse Events (TEAEs) (Number of events), Weeks 0-30. Semaglutide 0.5 mg: 228; Semaglutide 1.0 mg: 197; Sitagliptin: 186.
As posted on ClinicalTrials.gov (NCT02254291), updated at source Sep 13, 2018. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.
| Semaglutide 0.5 mgn=103 | Semaglutide 1.0 mgn=102 | Sitagliptinn=103 |
|---|---|---|
| 228 | 197 | 186 |
Percent of participants affected, All AEs presented here are treatment emergent adverse events (TEAE). A TEAE included events that had onset date (or increase in severity) on or after the first day of exposure (week 0) to randomised.... The most common events the registry lists.
| Event | Semaglutide 0.5 mg | Semaglutide 1.0 mg | Sitagliptin |
|---|---|---|---|
| Any serious event | 5.8% | 2% | 1.9% |
| Nasopharyngitis | 16.5% | 17.6% | 29.1% |
| Constipation | 14.6% | 11.8% | 3.9% |
| Nausea | 10.7% | 12.7% | 0% |
| Lipase increased | 9.7% | 6.9% | 3.9% |
| Diarrhoea | 6.8% | 8.8% | 1.9% |
| Decreased appetite | 8.7% | 7.8% | 0% |
| Abdominal discomfort | 3.9% | 6.9% | 0% |
| Amylase increased | 5.8% | 2% | 1.9% |
| Semaglutide 0.5 mgn=103 | Semaglutide 1.0 mgn=102 | Sitagliptinn=103 |
|---|---|---|
| 0 | 1 | 0 |
| Semaglutide 0.5 mgn=103 | Semaglutide 1.0 mgn=102 | Sitagliptinn=103 |
|---|---|---|
| -1.87(0.07) | -2.18(0.07) | -0.74(0.07) |
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.
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
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.