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Long -Term Efficacy of Dapagliflozin in T2DM Patients Receiving High-Dose Insulin

Long -Term Efficacy of Dapagliflozin in T2DM Patients Receiving High-Dose Insulin. John P.H. Wilding, DM, FRCP. Efficacy Outcome Measures. At week 24 Primary efficacy outcome Change in HbA1c Secondary efficacy outcomes Change in total body weight Change in mean daily insulin dose

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Long -Term Efficacy of Dapagliflozin in T2DM Patients Receiving High-Dose Insulin

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  1. Long-Term Efficacy of Dapagliflozin in T2DM Patients Receiving High-Dose Insulin John P.H. Wilding, DM, FRCP

  2. Efficacy Outcome Measures • At week 24 • Primary efficacy outcome • Change in HbA1c • Secondary efficacy outcomes • Change in total body weight • Change in mean daily insulin dose • Patients with mean daily insulin dose reductions ≥10% from baseline • Change in fasting plasma glucose • At week 48 • Are changes seen at 24 weeks maintained? Wilding JPH, et al. Ann Intern Med. 2012;156:405-415.

  3. Change in HbA1c at 24 and 48 Weeks *P <.001 Wilding JPH, et al. Ann Intern Med. 2012;156:405-415.

  4. Change in Body Weight at 24 and 48 Weeks *P <.001 Wilding JPH, et al. Ann Intern Med. 2012;156:405-415.

  5. Change in Daily Insulin Dose at 24 and 48 Weeks *P <.001 Wilding JPH, et al. Ann Intern Med. 2012;156:405-415.

  6. % Patients with Mean Daily Dose Reductions ≥ 10% from Baseline Wilding JPH, et al. Ann Intern Med. 2012;156:405-415.

  7. Change in Fasting Plasma Glucose at 24 and 48 Weeks *P <.001) Wilding JPH, et al. Ann Intern Med. 2012; 156: 405-415.

  8. Safety (% Patients) • Treatment-related adverse events • Placebo: 20.8% • DAPA: 21.3% (2.5 mg); 29.2% (5 mg); 29.1% (10 mg) • Serious adverse events • Placebo: 13.2% • DAPA: <13.4% • ≥1 event of hypoglycemia • Placebo: 51.8% • DAPA: 60.4% (2.5 mg); 55.7% (5 mg); 53.6% (10 mg) • Serious/severe hypoglycemia • Placebo: 1 hypoglycemic coma • DAPA: 2 patients in 5 mg group Wilding JPH, et al. Ann Intern Med. 2012;156:405-415.

  9. Genital/Urinary Tract Infections • Compared with placebo, a significantly greater % of patients receiving DAPA had events suggesting genital infection • There was no significant difference between % of placebo and DAPA patients with events suggesting urinary tract infections • Most suggestive events were mild to moderate and responded to routine treatment Wilding JPH, et al. Ann Intern Med. 2012;156:405-415.

  10. Renal EffectsDAPA •  Urinary glucose, hematocrit, serum creatinine, blood urea nitrogen, and cystatin C levels • Serum uric acid levels and calculated creatinine • Greater absolute changes in the dapagliflozin groups, compared with placebo • These changes were not accompanied by increased rates of renal impairment or failure, hypotension, dehydration, or hypovolemia Wilding JPH, et al. Ann Intern Med. 2012;156:405-415.

  11. Conclusions • Compared with placebo + insulin, DAPA + insulin resulted in significant reductions from baseline in HbA1c, body weight, mean daily insulin dose, and fasting plasma glucose, and a significant increase in % patients with ≥10% decrease in daily insulin dose • In comparison to a decrease in insulin dose in DAPA groups at 24 and 48 weeks, insulin requirement increased in placebo patients • Benefits seen at 24 weeks were sustained or improved at 48 weeks, demonstrating that DAPA continues to work as long as the patient’s kidneys continue to function • There was no kidney damage associated with DAPA in this study • Genital/urinary infections were mild to moderate and managed with routine therapy • DAPA + insulin is an appropriate choice for T2DM patients who have poor glycemic control on insulin, particularly those who are obese Wilding JPH, et al. Ann Intern Med. 2012; 156: 405-415.

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