Phase 3
Completed N=601
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
Source: ClinicalTrials.gov NCT02207374 ↗Enrolled (actual)
601
Serious AEs
6.5%
Results posted
Jan 2019
Primary outcomePrimary: Number of Treatment Emergent Adverse Events (TEAEs) — 909; 954; 269 Number of events
◆ Published Evidence
Highly cited
125citations · ~16 / year
Safety and efficacy of once-weekly semaglutide vs additional oral antidiabetic drugs in Japanese people with inadequately controlled type 2 diabetes: A randomized trial.
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.
Linked Publications (4)
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Safety and efficacy of once-weekly semaglutide vs additional oral antidiabetic drugs in Japanese people with inadequately controlled type 2 diabetes: A randomized trial.
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Exposure-response analysis for evaluation of semaglutide dose levels in type 2 diabetes.
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Semaglutide s.c. Once-Weekly in Type 2 Diabetes: A Population Pharmacokinetic Analysis.
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Effects of semaglutide on risk of cardiovascular events across a continuum of cardiovascular risk: combined post hoc analysis of the SUSTAIN and PIONEER trials.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Treatment Emergent Adverse Events (TEAEs) |
909; 954; 269 | — |
| SECONDARY Number of Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes |
4; 8; 2 | — |
| SECONDARY Change in Glycosylated Haemoglobin A1c (HbA1c) |
-1.74; -2.03; -0.67 | — |
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
Data sourced from ClinicalTrials.gov (NCT02207374) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.