Emerging drugs for the treatment of type 1 diabetes mellitus: a review of phase 2 clinical trials

ABSTRACT

Introduction

Despite therapeutic advances in the field of diabetes management since the discovery of insulin 100 years ago, there are still unmet clinical needs for people with type 1 diabetes mellitus (T1DM).

Areas covered

Genetic testing and islet autoantibodies testing allow researchers to design prevention studies. This review discusses the emerging therapy for prevention of T1DM, disease modification therapy in early course of T1DM, and therapies and technologies for established T1DM. We focus on phase 2 clinical trials with promising results, thus avoiding the exhausted list of every new therapy for T1DM.

Expert opinion

Teplizumab has demonstrated potential as a preventative agent for individuals at risk prior to the onset of overt dysglycemia. However, these agents are not without side effects, and there are uncertainties on long-term safety. Technological advances have led a substantial influence on quality of life of people suffering from T1DM. There remains variation in uptake of new technologies across the globe. Novel insulins (ultra-long acting), oral insulin, and inhaled insulin attempt to narrow the gap of unmet needs. Islet cell transplant is another exciting field, and stem cell therapy might have potential to provide unlimited supply of islet cells.

KEYWORDS:

• Immunotherapy
• insulin pump
• oral insulin
• type 1 diabetes
• therapy for type 1 diabetes
• ultra-long-acting insulin

Declaration of interest

T Min reports receiving personal fees and travel grants from AstraZeneca, Boehringer Ingelheim & Napp. S Bain reports receiving grants and personal fees from AstraZeneca, Novo Nordisk and Sanofi-Aventis, as well as personal fees from Boehringer Ingelheim, Eli Lilly and Merck Sharp & Dohme. S Bain also report receiving grants from Medscape and has provided expert advice to All-Wales Medicines Strategy Group and National Institute for Health and Care Excellence UK, with a partnership in Glycosmedia. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

A reviewer on this manuscript has disclosed that they have served on advisory boards for some of the companies discussed in this review, have conducted clinical trials that were discussed in this review, and have served on Data and Safety Monitoring Boards associated with some of these agents. Peer reviewers on this manuscript have no other relevant financial relationships or otherwise to disclose.

Additional information

Funding

This paper was not funded.