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.
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Table of Contents
1 Table of Contents
1 Table of Contents 2
2 Introduction 3
2.1 Report Guidance 4
3 Marketed Products 5
3.1 Basal Insulin Therapies (Administered Subcutaneously One to Two Times Daily) 5
3.2 Bolus Insulin Therapies 7
3.2.1 Bolus Insulin (Administered Subcutaneously around Meal Times) 7
3.2.2 Bolus Insulin (Administered via CSII) 8
3.3 Insulin Combination Therapies 8
3.4 Non-Insulin Adjuvant Therapies 8
3.5 Disease Modifying Therapies 9
4 Pipeline Products 10
4.1 Changes to Basal Insulin Therapies (Administered Subcutaneously One to Two Times Daily), 2016-2022 10
4.2 Changes to Bolus Insulin Therapies, 2016-2022 10
4.2.1 Changes to Bolus Insulin (Administered Subcutaneously around Meal Times) 10
4.2.2 Changes to Bolus Insulin (Administered via CSII) 11
4.3 Changes to Combination Therapies, 2016-2022 11
4.4 Changes to Non-Insulin Adjuvant Therapies, 2016-2022 11
4.5 Changes to Disease-Modifying Therapies, 2016-2022 12
5 Appendix 14
5.1 Abbreviations 14
5.2 References 14
5.3 Research Methodology 17
5.4 Contact Us 17
5.5 Disclaimer 17
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