Display Settings:

Format

Send to:

Choose Destination
See comment in PubMed Commons below
Perspect Clin Res. 2012 Jul;3(3):109-12. doi: 10.4103/2229-3485.100660.

Diabetes mellitus: Exploring the challenges in the drug development process.

Author information

  • 1Dr. Reddy's Laboratories Ltd, Global Medical Affairs, Hyderabad, Andhra Pradesh, India.

Abstract

Diabetes mellitus has reached epidemic proportions and continues to be a major burden on society globally. The International Diabetes Federation (IDF) estimated the global burden of diabetes to be 366 million in 2011 and predicted that by 2030 this will have risen to 552 million. In spite of newer and effective treatment options, newer delivery and diagnostic devices, stricter glycaemic targets, better treatment guidelines and increased awareness of the disease, baseline glycosylated hemoglobin remains relatively high in subjects diagnosed and treated with type 2 diabetes. The search continues for an ideal anti diabetic drug that will not only normalize blood glucose but also provide beta cell rest and possibly restoration of beta cell function. The development of anti diabetic drugs is riddled with fundamental challenges. The concept of beta cell rest and restoration is yet to be completely understood and proven on a long term. The ideal therapeutic approach to treating type 2 diabetes is not yet determined. Our understanding of drug safety in early clinical development is primarily limited to "Type A" reactions. Until marketing authorization most drugs are approved based on the principle of confirming non-inferiority with an existing gold standard or determining superiority to a placebo. The need to obtain robust pharmaco-economic data prior to marketing authorization in order to determine appropriate pricing of a new drug remains a major challenge. The present review outlines some of the challenges in drug development of anti-diabetic drugs citing examples of pulmonary insulin, insulin analogues, thiazolidinediones and the GLP1 analogues.

KEYWORDS:

Anti diabetic drugs; GLP1 analogues; drug development; insulin analogues; pulmonary insulin; type 2 diabetes mellitus

PMID:
23125962
[PubMed]
PMCID:
PMC3487225
Free PMC Article
PubMed Commons home

PubMed Commons

0 comments
How to join PubMed Commons

    Supplemental Content

    Full text links

    Icon for Medknow Publications and Media Pvt Ltd Icon for PubMed Central
    Loading ...
    Write to the Help Desk