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A 28-week, prospective, single-arm, open label phase 4 study to evaluate treatment optimization with once-daily insulin glargine HOE901-300 IU/ml in combination with prandial rapid-acting insulin analogue in patients with type 1 diabetes previously uncontrolled on twice daily basal insulin as part of basal-bolus therapy

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A 28-week, prospective, single-arm, open label phase 4 study to evaluate treatment optimization with once-daily insulin glargine HOE901-300 IU/ml in combination with prandial rapid-acting insulin analogue in patients with type 1 diabetes previously uncontrolled on twice daily basal insulin as part of basal-bolus therapy

Status: Completed
Phase of Trial: Phase IV

Latest Information Update: 16 Jul 2019

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At a glance

  • Drugs Insulin glargine (Primary)
  • Indications Type 1 diabetes mellitus
  • Focus Therapeutic Use
  • Acronyms OPTIMIZE
  • Sponsors Sanofi

    • Most Recent Events

    • 11 Jun 2019 Primary endpoint (Mean HbA1c change) has been met, according to results presented at the 79th Annual Scientific Sessions of the American Diabetes Association.
    • 11 Jun 2019 Results presented at the 79th Annual Scientific Sessions of the American Diabetes Association
    • 26 Jun 2018 Results of Phase 4 OPTIMIZE Study, Belgian Cohort (n=48) presented at the 78th Annual Scientific Sessions of the American Diabetes Association

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