What SUSTAIN 3 measured first
| Semaglutide 1.0 mgn=404 | Exenatide ER 2.0 mgn=405 |
|---|---|
| -1.54(0.06) | -0.92(0.06) |
Efficacy and Safety of Semaglutide Once-weekly Versus Exenatide ER 2.0 mg Once-weekly as add-on to 1-2 Oral Antidiabetic Drugs (OADs) in Subjects With Type 2 Diabetes (SUSTAIN™ 3 - vs. QW GLP-1)
Change From Baseline in HbA1c (Glycosylated Haemoglobin) (percentage of glycosylated haemoglobin), Week 0, week 56. Semaglutide 1.0 mg: -1.54; Exenatide ER 2.0 mg: -0.92.
As posted on ClinicalTrials.gov (NCT01885208), updated at source Jun 13, 2019. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.
| Semaglutide 1.0 mgn=404 | Exenatide ER 2.0 mgn=405 |
|---|---|
| -1.54(0.06) | -0.92(0.06) |
Percent of participants affected, All adverse events are treatment-emergent adverse events (TEAEs). 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 | Sema 1.0 mg | Exenatide ER |
|---|---|---|
| Any serious event | 9.4% | 5.9% |
| Nausea | 22.3% | 11.9% |
| Injection site nodule | 0% | 12.1% |
| Lipase increased | 10.1% | 12.1% |
| Diarrhoea | 11.4% | 8.4% |
| Nasopharyngitis | 9.7% | 9.4% |
| Headache | 9.4% | 9.6% |
| Decreased appetite | 7.9% | 5.2% |
| Vomiting | 7.2% | 6.2% |
| Dyspepsia | 6.7% | 4.7% |
| Constipation | 6.4% | 5.2% |
| Semaglutide 1.0 mgn=404 | Exenatide ER 2.0 mgn=405 |
|---|---|
| -5.63(0.29) | -1.85(0.29) |
| Semaglutide 1.0 mgn=404 | Exenatide ER 2.0 mgn=405 |
|---|---|
| -51.22(2.36) | -36.1(2.45) |
| Measure | Semaglutide 1.0 mgn=404 | Exenatide ER 2.0 mgn=405 |
|---|---|---|
| Systolic blood pressure | -4.6(0.68) | -2.23(0.7) |
| Diastolic blood pressure | -1.0(0.45) | -0.1(0.46) |
| Semaglutide 1.0 mgn=404 | Exenatide ER 2.0 mgn=405 |
|---|---|
| 4.98(0.26) | 3.96(0.27) |
| Measure | Semaglutide 1.0 mgn=404 | Exenatide ER 2.0 mgn=405 |
|---|---|---|
| Yes | 190 | 89 |
| No | 214 | 316 |
This trial is conducted in Europe and North and South America. The aim of the trial is to investigate the efficacy and safety of semaglutide once-weekly versus exenatide ER (extended release) 2.0 mg once-weekly as add-on to 1-2 oral antidiabetic drugs (OADs) in subjects with type 2 diabetes.
Inclusion Criteria: - Subjects diagnosed with type 2 diabetes and on stable diabetes treatment with 1-2 OADs (Metformin equal to or above 1500 mg or maximum tolerated dose and/or thiazolidinedione (TZD) and sulfonylureas (SUs) equal to or above half of maximum dose allowed according to national label) for at least 90 days prior to screening. Stable is defined as unchanged medication and unchanged dose - HbA1c 7.0 - 10.5 % (53 - 91 mmol/mol) (both inclusive) Exclusion Criteria: - Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using an adequate contraceptive method throughout the trial including the 5 week follow-up period (adequate contraceptive measures as required by local law or practice) - Any chronic disorder or severe disease which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol - Treatment with glucose lowering agent(s) other than stated in the inclusion criteria in a period of 90 days before screening. An exception is short-term treatment (7 days or less in total) with insulin in connection with inter-current illness - History of chronic or idiopathic acute pancreatitis - Screening calcitonin value equal to or above 50 ng/L (pg/mL) - Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2) - Impaired renal function defined as estimated glomerular filtration rate (eGFR) below 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.