Summary

Type I diabetes mellitus (T1DM) is a metabolic disease characterized by chronic hyperglycemia, and is caused by defective insulin secretion by pancreatic beta cells. Under normal circumstances these cells would secrete insulin into the blood stream, which facilitates the uptake of glucose by target cells for metabolism, subsequently lowering blood glucose levels. The disease typically has childhood onset and patients cannot survive without pharmacotherapy, which has historically consisted of multiple subcutaneous administrations of insulin analogs per day. Furthermore, the disease is associated with organ failure and diabetic ketoacidosis, which are both potentially fatal side-effects. The disease therefore represents a significant burden and daily inconvenience for patients.

There is currently no cure for the disease and the annual cost of therapy is high. Significant unmet need exists, both for more cost-effective treatment options, and also for effective treatment with favorable routes of administration. There a number of ways in which the T1DM market is evolving in order to satisfy unmet need, including the repositioning of T2DM drugs and the development of novel forms of therapy.

This tabular heatmap framework, designed to provide an easily digestible summary of clinical characteristics, provides detailed information on all late-stage clinical trial results for products in the T1DM market and late-stage pipeline. These are split along therapy lines, and are therefore reflective of the treatment algorithm.

All safety and efficacy endpoints reported in these trials are displayed, for both the drug and placebo groups. In addition, key study characteristics such as the size, composition and patient segment of the study population are provided. These results are presented in a visually accessible, color-coded manner in order to maximize ease of use.

The accompanying text provides a detailed analysis of the clinical benchmarks set by the current market landscape, and the anticipated changes to these benchmarks, and to the treatment algorithm, as a result of the late-stage pipeline.

Scope

- How is the T1DM market landscape expected to evolve with the repositioning of currently successful products and the advent of promising novel pipeline products?
- What are the clinical characteristics of currently approved therapies for T1DM, in terms of specific safety and efficacy parameters?
- How are clinical safety and efficacy parameters linked to the key unmet needs in this indication?
- How will new therapeutic forms affect the market for currently successful recombinant peptides, and are they able to yield comparable clinical efficacy results to currently favored therapies?
- In a market dominated by recombinant peptides, do small molecule therapies have sufficient differentiating characteristics to have a strong impact?
- How will the repositioning of currently successful T2DM therapies affect the competitive landscape?

Reasons to buy

- Understand the current clinical landscape by considering the treatment options available for each patient segment.
- Visually compare the currently approved treatments available at each line of therapy, based on the most important efficacy and safety parameters tested in clinical trials.
- Assess the current late-stage pipeline, in terms of the likely positioning of each product and the implications for the clinical landscape at each line of therapy.
- Understand the relative strengths and weaknesses of the studies used to gather these data.
- Build up a nuanced understanding of the clinical benchmarks set by these products, and consider how the current late-stage pipeline will affect these benchmarks.
- Assess your own pipeline programs in light of these benchmarks in order to optimally position them and maximize uptake by clinicians.