Abstract
Introduction: 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.Keywords: Type 1 diabetes, new drug development, regulatory environment, FDA, EMA, new mechanisms of action, insulins; anti-inflammatory drugs, immunomodulatory, islet regeneration.
Current Diabetes Reviews
Title:Addressing Unmet Medical Needs in Type 1 Diabetes: A Review of Drugs Under Development
Volume: 13 Issue: 3
Author(s): Friedrich Mittermayer*, Erica Caveney, Claudia De Oliveira, G. Alexander Fleming, Loukas Gourgiotis, Mala Puri, Li-Jung Tai and J. Rick Turner
Affiliation:
- Quintiles GmbH, Stella-Klein-Löw Weg 15, Rund 4, Haus B, OG 4, 1020 Vienna,Austria
Keywords: Type 1 diabetes, new drug development, regulatory environment, FDA, EMA, new mechanisms of action, insulins; anti-inflammatory drugs, immunomodulatory, islet regeneration.
Abstract: Introduction: 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.Export Options
About this article
Cite this article as:
Mittermayer Friedrich*, Caveney Erica, De Oliveira Claudia, Fleming Alexander G., Gourgiotis Loukas, Puri Mala, Tai Li-Jung and Turner Rick J., Addressing Unmet Medical Needs in Type 1 Diabetes: A Review of Drugs Under Development, Current Diabetes Reviews 2017; 13 (3) . https://dx.doi.org/10.2174/1573399812666160413115655
DOI https://dx.doi.org/10.2174/1573399812666160413115655 |
Print ISSN 1573-3998 |
Publisher Name Bentham Science Publisher |
Online ISSN 1875-6417 |
- Author Guidelines
- Graphical Abstracts
- Fabricating and Stating False Information
- Research Misconduct
- Post Publication Discussions and Corrections
- Publishing Ethics and Rectitude
- Increase Visibility of Your Article
- Archiving Policies
- Peer Review Workflow
- Order Your Article Before Print
- Promote Your Article
- Manuscript Transfer Facility
- Editorial Policies
- Allegations from Whistleblowers
- Announcements
Related Articles
-
Uncommon Association Between Diabetic Ketoacidosis, Thyrotoxicosis, Cutaneous Abscess and Acute Pericarditis in an Immunocompetent Patient: A Single Case Report and Literature Review
Current Diabetes Reviews Serum Insulin Degrading Enzyme Level and Other Factors in Type 2 Diabetic Patients with Mild Cognitive Impairment
Current Alzheimer Research Exercise and Nutraceuticals: Eminent Approach for Diabetic Neuropathy
Current Molecular Pharmacology The IGF-I Signaling Pathway
Current Pharmaceutical Design Role of Monocarboxylate Transporters in Drug Delivery to the Brain
Current Pharmaceutical Design An Approach to Diabetic Ketoacidosis in an Emergency Setting
Reviews on Recent Clinical Trials Is it Worth CANVASing for CREDENCE? A Benefit-risk Analysis
Current Diabetes Reviews A Case Report: Euglycemic Diabetic Ketoacidosis Presenting as Chest Pain in a Patient on a Low Carbohydrate Diet
Current Diabetes Reviews Association Between Seizures and Diabetes Mellitus: A Comprehensive Review of Literature
Current Diabetes Reviews Sodium Glucose Cotransporter-2 Inhibitor Treatment and the Risk of Diabetic Ketoacidosis in Denmark: A Retrospective Cohort Study of Five Years of Use
Current Drug Safety The Role of Diabetes Mellitus in Sexual and Reproductive Health: An Overview of Pathogenesis, Evaluation, and Management
Current Diabetes Reviews Growing Burden of Diabetes in Sub- Saharan Africa: Contribution of Pesticides ?
Current Diabetes Reviews Maturity-Onset Diabetes of the Young: An Overview with Focus on the Middle East
Current Molecular Medicine Renoprotective Effects of SGLT2 Inhibitors: Beyond Glucose Reabsorption Inhibition
Current Vascular Pharmacology Current Concepts in Gastric Motility in Diabetes Mellitus
Current Diabetes Reviews Clinical Management of Diabetes Mellitus in the Older Adult Patient
Current Diabetes Reviews Sex-Gender Differences in Diabetes Vascular Complications and Treatment
Endocrine, Metabolic & Immune Disorders - Drug Targets Challenges for Gene Therapy of Type 1 Diabetes
Current Gene Therapy Brittle Type 1 Diabetes Mellitus
Current Medicinal Chemistry Non-glycemic Adverse Effects of Insulin
Current Diabetes Reviews