Oral Diabetes Drugs

Diabetes is a disease caused by high levels of blood glucose resulting from improper production of insulin or action of insulin.

• Type 1: In this Diabetes, the cells that make the hormone insulin regulate the blood glucose are destroyed by the body immune system. This is also called as juvenile onset diabetes as it occurs mainly in children and young adults. 5%-10% of all the cases of diabetes have Type I diabetes. Clinical trials are being pursued and planned to prevent type I diabetes. This is also called as Insulin Dependent Diabetes Mellitus (IDDM).
• Type 2: In this case, either the cells do not use insulin properly or the body does not produce enough insulin. 90% - 95% of the diabetics have Type 2 diabetes. This type of disease is also called as non-insulin dependent diabetes mellitus (NIDDM) and is mainly observed in people with old age, obese, family history of diabetes, history of gestational diabetes, impaired glucose metabolism, physical inactivity and race/ethnicity.
• Gestational Diabetes: Increase in the levels of blood sugar during pregnancy is called gestational diabetes.

Incidence

In year 2004, diabetes ( Both type I and type II ) was diagnosed in 1.4 million adults between the age of 18-79 years (Figure 1). The incidence of diabetes was lower in adults having an age between 18-44 years compared to other groups (Figure 2). From 1997 through 2004, the age adjusted incidence of diagnosed diabetes ( Both type I and type II )increased by 35% among men and 46% among women (Figure 3).

Figure 1. Annual number (in thousands) of new cases of diagnosed diabetes among adults aged 18-79 years, in United States from 1997-2004. Source

Figure 3. Gender based incidence of diagnosed diabetes per 1000 population aged from 18-79 years in U.S. Source

Figure 2. Incidence of diagnosed diabetes per 1000 population aged 18-79 years, by age in U.S from 1997 to 2004. Source

• The following table attempts to extrapolate the incidence rate for Diabetes( both type I and type II ) to the populations of various countries and regions.Cure reasearch, Statistics by Country for Diabetes

Prevalence

The prevalence of diabetes( Both type I and type II ) in U.S. during the years 1980 to 2005, increased from 5.6 million to 15.8 million (Figure 4). Especially people aged from 65 to 74 had the highest prevalence compared to other age groups (Figure 5). The prevalence of the disease was similar in both men and women till the year 1998 but from 1999, the prevalence of the disease increased highly in men compared to females (Figure 6).

Figure 4. Number (millions) of persons with diagnosed diabetes from year 1980 to 2005 in United States. Source

Figure 5. Age dependent Prevalence of diagnosed diabetes in United States from year 1980 to 2005. Source

Figure 6. Gender dependent Prevalence of diagnosed diabetes in United States from year 1980 to 2005. Source

• The following table attempts to extrapolate the prevalence rate for Diabetes( both type I and type II ) to the populations of various countries and regions.Cure reasearch, Statistics by Country for Diabetes.

• The Insulin market in 2006 was largely dominated by two players, Novo Nordisk of Denmark and Eli Lilly of USA.
• India and China are emerging as the most potential future markets for insulin delivery devices.
• Growing at a CAGR of 14.09%, global insulin market will reach US$ 14.5 Billion by 2010 from US$ 7.5 Billion in 2005.
• Over 60% of the insulin sold in 2006 was sold in pen devices.
• Insulin pen devices dominate the market in Europe and Japan whereas syringes and pumps dominate the US market.
• There was a big improvement in the global diabetes market for innovation particularly in the field of non-invasive methods of insulin delivery, including inhalable, oral and patch technology. Source
• There are 3 key new OAD classes; PPAR agonists, GLP-1 agonists/DPP IV inhibitors, and amlinomimetic agents. High forecasted sales are anticipated in 2011 for the GLP-1 agonist Exenatide LAR and the DPP-IV inhibitor Galvus at $2,902.9m and $1,228.7m, respectively. Source

A. Competitive dynamics of the leading players in the global diabetes market, 2005 B. Global diabetes market share by geography, 2005] C. Worldwide Diabetes Market, 2000, 2001, 2002 and 2007 D. Global* market share of leading insulins (%), 1999-2003

Overall categorization of diabetes treatments

Products: Oral Hypoglycemic Agents

Products: Fixed Drug Combinations

Product pipeline

Product Pathways

Product

Product pipeline

Search strategy

• Database/Vendor: Micropat
• Search scope: US Granted US Applications EP-A EP-B WO JP (bibliographic data only) DE-C,B DE-A DE-T DE-U GB-A FR-A; English Title
• Years: Issue/Publication Date: >20051231
• Search String: (Diabetes OR diabetic) AND (treatment OR treating)
• Hits: 618/217 patents (with/with out family members)
• Date of search: 11 July 2007

Top players and IPC classes

IPC code definition

Geographical Distribution and Treatment Approaches

IP activity and Treatment Approaches

• Decline in the IP activity during 2005 and 2006 is due 18 months publication delay of patent document.

Approved/On-going

• Diabetes Mellitus, Insulin Action and Resistance at Breckenridge, Colorado from January 22 - 27, 2008
• Diabetes UK Annual Professional Conference 2008 at Glasgow from 05 Mar 2008 09:00 to 07 Mar 2008 17:00
• 7th International Diabetes Federation Western Pacific Region Congress at Wellington, New Zealand on 30 Mar 2008.
• 1st International Conference on Advanced Technologies & Treatments for Diabetes at Czech Republic during 27 Feb to 01 Mar 2008.
• Discovery Strategies Conference: Modeling Human Metabolic Syndrome and Type 2 Diabetes in Rodents at US during Aug-05-2007.
• 7th International Conference for Clinical Endocrinology,Diabetes and Infertility at Egypt during Sep-06-2007.
• CDA/CSEM Professional Conference and Annual Meetings at British Columbia during October 24-27, 2007.

Conference Update: American Diabetic Association 2007

Conference highlights for Oral Hypoglycemic Agents

1. Oral hypoglecemic agents and their role in diabetes treatment. The focus was the recent meta analysis published in NEJM, showing increase CV mortality with Rosiglitazone. The panel consensus was that while awaiting more safety data, for now those patients who are tolerating Rosiglitazone should continue taking them, whereas newly diagnosed patients should try alternative treatment. Also all PPAR agonists should be treated as distinct entities rather than having class effect.
2. 12 different diabetes products are in various stages of development, and there were about 55 abstracts talking about DPP–IV inhibitors. They are especially useful for:
   • The elderly
   • Those with renal insufficiency
   • Heart failure patients
3. Amyline analogue (Pramlinitide) was combined with Insulin for treatment of Type 2 DM and results were favorable.
4. Continuous glucose monitoring using implanted glucose sensors is a step forward in evolving technology. Yet it is still very expensive and best for highly trained patients on intensive insulin therapy.

Samir Raiyani

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