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Insulin Delivery Systems

Oral Insulin (ORMD-0801) Effects on Glucose Parameters in Uncontrolled T2DM on OADs

book_2 Source: ADA 2020 - Poster session
calendar_today Published on Medfyle: July 2020
headphones 5 min

This Medfyle was published more than two years ago. More recent Medfyle on this topic may now be available.

Key messages

  • This randomized, placebo-controlled, multi-center, phase 2b study aimed to assess the efficacy of 12-weeks of 32 mg ORMD-0801, administered once, twice or three times daily in 272 T2DM subjects.
  • ORMD-0801 was not associated with an increased risk of hypoglycemia or with severe or serious side effects.
  • No significant weight gain or postprandial glucose parameters were recorded over the 12-week treatment period.
  • This study clearly demonstrated that when considering changes in 12-week HbA1c levels, there is no significant benefit to be derived from dosing more than once daily, at night.
  • QD dosing will certainly enhance subject compliance and reduce treatment costs.
Presenting Author
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Julio Rosenstock, MD
Institute of Endocrinology, Metabolism & Hypertension, Tel-Aviv Sourasky Medical Center

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J. Rosenstock: Other Relationship; Self; Applied Therapeutics, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Intarcia Therapeutics, Janssen Pharmaceuticals, Inc., Novo Nordisk Inc., Sanofi, Research Support; Self; AstraZeneca, Bristol-Myers Squibb, Genentech, Inc., GlaxoSmithKline plc., Lexicon Pharmaceuticals, Inc., Oramed Pharmaceuticals, PegBio Co., Ltd., Pfizer Inc., REMD Biotherapeutics.