title: Addressing Unmet Medical Needs in Type 1 Diabetes: A Review of Drugs Under Development.
abstract: The incidence of type 1 diabetes (T1D) is increasing worldwide and there is a very large need for effective therapies. Essentially no therapies other than insulin are currently approved for the treatment of T1D. Drugs already in use for type 2 diabetes and many new drugs are under clinical development for T1D, including compounds with both established and new mechanisms of action. Content of the Review: Most of the new compounds in clinical development are currently in Phase 1 and 2. Drug classes discussed in this review include new insulins, SGLT inhibitors, GLP-1 agonists, immunomodulatory drugs including autoantigens and anti-cytokines, agents that regenerate β-cells and others. Regulatory Considerations: In addition, considerations are provided with regard to the regulatory environment for the clinical development of drugs for T1D, with a focus on the United States Food and Drug Administration and the European Medicines Agency. Future opportunities, such as combination treatments of immunomodulatory and beta-cell regenerating therapies, are also discussed.
authors.affiliation: Quintiles GmbH, Stella-Klein-Löw Weg 15, Rund 4, Haus B, OG 4, 1020 Vienna. Austria.
authors.forename: Friedrich
authors.initials: F
authors.lastname: Mittermayer
authors.affiliation: Diabetes Center of Excellence, Quintiles, Durham, NC. United States.
authors.forename: Erica
authors.initials: E
authors.lastname: Caveney
authors.affiliation: Cardiovascular and Metabolic Diseases, Quintiles, Durham, NC. United States.
authors.forename: Claudia
authors.initials: C
authors.lastname: De Oliveira
authors.affiliation: Kinexum, Harpers Ferry, WV. United States.
authors.forename: G Alexander
authors.initials: GA
authors.lastname: Fleming
authors.affiliation: Cardiovascular and Metabolic Diseases, Quintiles, Reading. United Kingdom.
authors.forename: Loukas
authors.initials: L
authors.lastname: Gourgiotis
authors.affiliation: Cardiovascular and Metabolic Diseases, Quintiles, Durham, NC. United States.
authors.forename: Mala
authors.initials: M
authors.lastname: Puri
authors.affiliation: Ionis Pharmaceuticals, Carlsbad, CA. United States.
authors.forename: Li-Jung
authors.initials: LJ
authors.lastname: Tai
authors.affiliation: Diabetes Center of Excellence, Quintiles, Durham, NC. United States.
authors.forename: J Rick
authors.initials: JR
authors.lastname: Turner
mesh_terms: D000818:Animals; D003922:Diabetes Mellitus, Type 1 / Q000188:drug therapy*; D055808:Drug Discovery; D006801:Humans; D007004:Hypoglycemic Agents / Q000494:pharmacology* / Q000627:therapeutic use
chemical_list: D007004:Hypoglycemic Agents
keywords: EMA; FDA; Type 1 diabetes; immunomodulatory; insulins;
  anti-inflammatory drugs; islet regeneration; new drug development; new mechanisms of action; regulatory environment