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Quick reference for prescribing Onglyza

  • +Indications and use
    Onglyza is approved for the treatment of patients with Type 2 diabetes as monotherapy* or as add-on therapy to metformin, a SU, a TZD, metformin plus a SU or insulin (with or without metformin), when these alone, together with diet and exercise, do not provide adequate glycaemic control.1 More on Onglyza indications available here.

    *In patients inadequately controlled by diet or exercise for whom metformin is inappropriate due to contraindications or intolerance.

    When Onglyza is used in combination with insulin or a SU, a lower dose of insulin or the SU may be required to reduce the risk of hypoglycaemia.1
  • +Dosing and administration Onglyza is taken as one 5 mg tablet anytime, with or without food. For patients with Type 2 diabetes and moderate or severe renal impairment, Onglyza is taken as one 2.5 mg tablet anytime, with or without food.1 More on Onglyza dosing available here.
  • +Contraindications Onglyza is contraindicated in patients with a hypersensitivity to the active substance or to any of the excipients, or with a history of a serious hypersensitivity reaction, including anaphylactic reaction, anaphylactic shock, and angioedema, to any DPP4 inhibitor.1 More on Onglyza contraindications available here.
  • +Known drug interactions There is a low risk of clinically meaningful interactions.1 More on drug interactions available here.
  • +Side effects Onglyza is generally well tolerated with a similar adverse-event profile to placebo.1 More on Onglyza tolerability available here.

Full Onglyza prescribing information available here.

SAVOR: Onglyza demonstrates proven CV safety in a diverse population of Type 2 diabetes patients with high CV risk20

In the largest CV outcomes trial to date, Onglyza added to standard of care has demonstrated no increased risk versus placebo added to standard of care for CV death, non-fatal MI or non-fatal ischaemic stroke in 16,492 adult patients with Type 2 diabetes who are at high risk for CV events.20

  • Study design

    SAVOR was a multicentre, randomised (1:1), double-blind trial of Onglyza added to standard of care versus placebo added to standard of care. The study involved 16,492 patients with HbA1c of 6.5–12.0% with established CVD or multiple CV risk factors (men aged ≥55 years or women aged ≥60 years and at least one of the following: Dyslipidaemia, hypertension, current smoking). A subgroup of patients had moderate-to-severe renal impairment (estimated glomerular filtration rate ≤50 mL/min).20

    Watch a short video on the
    diverse SAVOR patient
    population

    • A total of 28 patients were lost to follow-up and 388 withdrew consent20

    Adapted from Scirica BM,et al. N Engl J Med 2013.20

    Post-marketing, multicentre, randomised, double-blind trial to evaluate Onglyza added to standard of care versus placebo added to standard of care in 16,492 adult patients with Type 2 diabetes with HbA1c 6.5% to 12.0% and at high risk for CV events. Onglyza was administered as 5 mg once daily (or 2.5 mg once daily in patients with estimated glomerular filtration rate ≤50 mL/min).

    Standard of care: All other therapy for the management of the patient’s diabetes and CVD (including adding, discontinuing or changing the dose of concomitant antihyperglycaemic drugs) was at the discretion of the responsible physician.20

  • Endpoints

    SAVOR assessed the CV outcomes with Onglyza added to standard of care versus placebo added to standard of care in patients with Type 2 diabetes at high CV risk.20

    Primary endpoint:20

    • A composite endpoint of non-fatal MI, non-fatal ischaemic stroke or CV death

    Onglyza did not increase the risk of MI, ischaemic stroke or CV death20

    Watch a short video
    summarising the key
    findings
    from SAVOR

    Adapted from Scirica BM,et al. N Engl J Med 2013.20

    SOC, standard of care: All other therapy for the management of the patient’s diabetes and CVD (including adding, discontinuing or changing the dose of concomitant antihyperglycaemic drugs) was at the discretion of the responsible physician.20


    Secondary efficacy endpoint20

    • Primary composite endpoint plus hospitalisation for heart failure, coronary revascularisation or unstable angina

    There was no increased risk for the secondary composite endpoint of MACE (CV death, MI or ischaemic stroke) or hospitalisation* for Onglyza added to standard of care versus placebo added to standard of care at 2 years20

    *Hospitalisation for unstable angina, coronary revascularisation or heart failure.

    SOC, standard of care: All other therapy for the management of the patient’s diabetes and CVD (including adding, discontinuing or changing the dose of concomitant antihyperglycaemic drugs) was at the discretion of the responsible physician.

    Adapted from Scirica BM,et al. N Engl J Med 2013.20

    • One component of the composite secondary endpoint, hospitalisation for heart failure, occurred at a greater rate with Onglyza added to standard of care (3.5%) versus placebo added to standard of care (2.8%)20
    • There was no imbalance in CV deaths due to heart failure (0.5% in each group according to 2-year Kaplan-Meier estimates)20

    Post-marketing, multicentre, randomised, double-blind trial to evaluate Onglyza added to standard of care versus placebo added to standard of care in 16,492 adult patients with Type 2 diabetes with HbA1c 6.5% to 12.0% and at high risk for CV events. Standard of care: All other therapy for the management of the patient’s diabetes and CVD (including adding, discontinuing or changing the dose of concomitant antihyperglycaemic drugs) was at the discretion of the responsible physician.

  • Glycaemic control

    During the study, therapy for the management of the patient’s Type 2 diabetes and CVD (including adding, discontinuing or changing the dose of concomitant antihyperglycaemic drugs) was at the discretion of the responsible physician.20

    • Patients treated with Onglyza added to standard of care had significantly lower HbA1c levels at Years 1 and 2 compared with placebo added to standard of care20

    • With Onglyza added to standard of care, significantly more patients had HbA1c levels <7% at 2 years of treatment versus placebo added to standard of care (40.0% vs 30.3%; p<0.001)20
    • Fewer patients required a dose increase or addition of another antidiabetes treatment with Onglyza added to standard of care versus placebo added to standard of care over 2 years20

     

    Post-marketing, multicentre, randomised, double-blind trial to evaluate Onglyza added to standard of care versus placebo added to standard of care in 16,492 adult patients with Type 2 diabetes at high CV risk. Standard of care: All other therapy for the management of the patient’s diabetes and CVD (including adding, discontinuing or changing the dose of concomitant antihyperglycaemic drugs) was at the discretion of the responsible physician.20

  • Safety and tolerability

    In the largest Type 2 diabetes CV outcomes trial to date, Onglyza has demonstrated a well characterised safety profile.20

    Pancreatitis and pancreatic cancer

    • Independently adjudicated incidence of pancreatitis was similar with Onglyza added to standard of care and placebo added to standard of care (0.3% for both)20
    • Overall rates of malignancy were balanced, and the observed rates of pancreatic cancer were lower in the Onglyza added to standard of care group (five patients) than the placebo added to standard of care group (12 patients)20

     

    Development and progression of microalbuminuria

    • Onglyza added to standard of care reduced the development and progression of microalbuminuria versus placebo added to standard of care over 2 years20

    Hypoglycaemia

    The incidence of hypoglycaemia was actively documented throughout the study. Overall rates of hypoglycaemia were higher with Onglyza added to standard of care (15.3%) versus placebo added to standard of care (13.4%)20

    • The rate of hypoglycaemia was not increased with Onglyza added to standard of care versus placebo added to standard of care in patients not receiving other antidiabetes treatments at baseline, in patients treated with metformin alone or insulin alone, or in patients with baseline HbA1c ≥7% taking insulin in combination with other antidiabetes treatments21
    • The rate of hypoglycaemia was increased with Onglyza added to standard of care versus placebo added to standard of care:
      • In patients taking a SU (a class of agents known to cause hypoglycaemia)21
      • In patients with baseline HbA1c <7% who were treated with insulin in combination with other antidiabetes treatments21

    Post-marketing, multicentre, randomised, double-blind trial to evaluate Onglyza added to standard of care versus placebo added to standard of care in 16,492 adult patients with Type 2 diabetes at high CV risk. Standard of care: All other therapy for the management of the patient’s diabetes and CVD (including adding, discontinuing or changing the dose of concomitant antihyperglycaemic drugs) was at the discretion of the responsible physician.20

                                                                                                                                                                     

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Working Together In Diabetes

Welcome to the international Onglyza® (saxagliptin)
website for healthcare professionals

This website is an international information resource intended for international healthcare professionals with an interest in Onglyza® (saxagliptin) and the treatment of type 2 diabetes. Please choose which site you require.

While the internet serves a global community, the pharmaceutical industry is subject to country-specific regulatory considerations. This means that the registration status and approved product labels of Onglyza® (saxagliptin) may not be the same in different countries. Information on this site is based on the Summary of Product Characteristics (SmPC) for Onglyza® (saxagliptin) in the EU. Please refer to your local Prescribing Information for full details.

Access the international Onglyza® (saxagliptin) website for healthcare professionals

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