following a full submission
saxagliptin (Onglyza®) is accepted for use within NHS Scotland.
Indication under review: In adult patients aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control as combination therapy with insulin (with or without metformin), when this regimen alone, with diet and exercise, does not provide adequate glycaemic control.
A phase IIIb, randomised, double-blind, placebo-controlled, parallel-group study in adult patients with type 2 diabetes mellitus and inadequate glycaemic control on a stable dose of insulin showed that addition of saxagliptin 5mg daily was superior to placebo for the primary endpoint of change from baseline in HbA1c at 24 weeks.
The manufacturer’s submission related only to the use of saxagliptin in combination with insulin (with or without metformin). SMC cannot recommend the use of saxagliptin as monotherapy.
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Medicine details
- Medicine name:
- saxagliptin (Onglyza)
- SMC ID:
- 772/12
- Indication:
- In adult patients aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control as combination therapy with insulin (with or without metformin), when this regimen alone, with diet and exercise, does not provide adequate glycaemic control.
- Pharmaceutical company
- AstraZeneca UK Ltd
- BNF chapter
- Endocrine system
- Submission type
- Full
- Status
- Accepted
- Date advice published
- 10 November 2014