QTERN (saxagliptin/dapagliflozin)

QTERN™ is a fixed dose combination of saxagliptin and dapagliflozin and is indicated in adults aged 18 years and older with type 2 diabetes mellitus1

Safety and Tolerability

QTERN™: A safety profile similar to its DPP-4 inhibitor and SGLT2 inhibitor monocomponents*1

  • No major hypoglycaemic events were reported in clinical trials.
  • Data from a pooled safety analysis of randomised, double-blind, active-/placebo-controlled phase 3 trials.
  • Qtern safety profile
    Qtern safety profile

     

    The safety profile of the combined use of saxagliptin plus dapagliflozin in these trials for up to 52 weeks was comparable to the safety profiles for the monocomponents.1

    The incidence of hypoglycaemia was low (1.4%) in subjects treated with saxagliptin plus dapagliflozin plus metformin. No episodes of major hypoglycaemia were reported, and no subject discontinued the study treatment due to hypoglycaemia.1

    *Data from a pooled safety analysis of randomised, double-blind active-/placebo-controlled phase 3 trials.

    Adverse reactions reported in ≥ 2 % of subjects treated with the combined use of saxagliptin + dapagliflozin in the pooled safety analysis, or if reported in < 2 % in the pooled safety analysis, they were based on the individual mono-components data.

    Urinary tract infection includes the following preferred terms: urinary tract infection, Escherichia urinary tract infection, pyelonephritis, and prostatitis.

    §Vulvovaginitis, balanitis and related genital infection include the following preferred terms: vulvovaginal mycotic infection, balanoposthitis, genital infection fungal, vaginal infection, and vulvovaginitis.

    "Adverse reactions were reported in ≥ 2 % of subjects with either mono-component and ≥ 1 % more than placebo, but not in the pooled analysis.

    Upper respiratory tract infection includes the following preferred terms: nasopharyngitis, influenza, upper respiratory tract infection, pharyngitis, rhinitis, sinusitis, pharyngitis bacterial, tonsillitis, acute tonsillitis, laryngitis, viral pharyngitis, and viral upper respiratory tract infection.

    #Dyslipidaemia includes the following preferred terms: dyslipidaemia, hyperlipidaemia, hypercholesterolaemia, and hypertriglyceridaemia.

    **Adverse reaction originated from saxagliptin or dapagliflozin post-marketing surveillance data

    ††Polyuria includes the following preferred terms: polyuria, and pollakiuria.

    ‡‡Haematocrit values > 55 % were reported in 1.3 % of the subjects treated with dapagliflozin 10 mg versus 0.4% of placebo subjects.

    §§Rash was reported during the postmarketing use of saxagliptin and dapagliflozin. Preferred terms reported in dapagliflozin clinical trials included in order of frequency: rash, rash generalised, rash pruritic, rash macular, rash maculo-papular, rash pustular, rash vesicular, and rash erythematous.

    DPP-4= dipeptidyl peptidase-4; SGLT2 = sodium-glucose cotransporter 2.