Category Archives: Diabetes


“According to the World diabetes atlas and Japi, South East Asia (primarily India) has the highest diabetic patient population. India contributes to 64 % of the total impaired glucose population in SE Asia and to 48% of the total diabetes population in SE Asia. Prevalence indicators point towards rising prevalence of diabetes in urban India, especially Southern India. Prevalence Indicators point towards prevalence of IGT higher then diabetes higher in the age group below 40 years. ”

“Half of all adults in the US have one chronic condition associated with an increased risk of cardiovascular disease, according to data from the National Health and Nutrition Examination Survey.
The report, from the Centers for Disease Control and Prevention, showed that 45% of individuals 20 years of age and older have hypercholesterolemia, hypertension, or diabetes. Of these, 3% of adults had all three conditions and 13% had two conditions. Hypertension and hypercholesterolemia were present in 9% of adults, and 3% of adults had high blood pressure and diabetes.
The prevalence of diagnosed or undiagnosed high blood pressure, elevated cholesterol levels, or diabetes varied by ethnicity, with non-Hispanic black individuals more likely than non-Hispanic white and Mexican American individuals to have at least one of these three conditions.
Compared with Mexican Americans, non-Hispanic white individuals were more likely to have only one of these chronic conditions, while non-Hispanic black people were more likely than white individuals and Mexican American individuals, 16.4% vs 12.8% and 12.7%, respectively, to have two comorbid conditions. In total, 4.6% of non-Hispanic black people have hypertension, hypercholesterolemia, and diabetes ”

“Since their introduction into the arsenal of metabolic research tools by DeFronzo et al. in the late seventies, glucose clamps have increasingly gained importance. Based on this technical principle, including its variants, e.g., hyperglycemic, euglycemic, and hypoglycemic glucose clamps, a great variety of different scientific topics can be tackled. For example, by means of the glucose clamp technique, both whole-body and organ-specific insulin sensitivity can be measured, predefined blood glucose concentrations for various purposes can be generated, and most importantly, blood glucose properties of almost any anti diabetic drug can be characterized with respect to their time-action profile. The latter can be done with a high level of precision and accuracy so that authorities like the European Medicines Agency regard glucose clamps as the gold standard for the investigation of new blood glucose-lowering drugs.
Beyond a specific experience in how to manage a glucose clamp, which is sometimes referred to as an “”art,”” the key factor for the success of each and every glucose clamp is the frequent, fast, and reliable measurement of the subject’s actual blood glucose. This is of huge importance as the deviation of actual blood glucose from blood glucose target level provides the signal on which the computation of the amount of glucose to be infused intravenously, aiming to adjust actual blood glucose to the predefined blood glucose target, is based. Meaning, the actual data from blood glucose measurements represent the input variable for some form of algorithm, either software or investigator based (the latter is also called experience, which will then determine the amount of glucose to be administered until the next blood glucose measurement is due).
The principal objective of this approach is to maintain blood glucose during glucose clamps both stable and close to the blood glucose target, i.e., to minimize deviations of the actual blood glucose from the target value. Based on inaccurate blood glucose measurements, however, it becomes quite easy to under- or over estimate true glucose requirements of subjects, leading to potential study endpoint bias. Most obviously, flawed study results could turn into misleading conclusions about the properties of a drug or a device in development.
References: J Diabetes Sci Technol Vol 2, Issue 5, September 2008″

“Diabetes, primarily type 2, is associated with an increased risk for some cancers, including liver, pancreas, endometrium, colorectal, breast, and bladder, but it is also associated with a decreased risk for prostate cancer. For other cancer types there is no association or the evidence is inconclusive.
The issue of diabetic treatments being associated with cancer risk has come up only recently.
However, these observed associations might be confounded by biologic changes that occur with diabetes, for which the drugs are being prescribed, the expert group points out. In addition, the association appears to exist for some types of cancer but not others.
When it comes to choosing between available diabetes therapies for the average patient, the experts state that “”cancer risk should not be a major factor”” in the choice, although “”more careful consideration”” might be required for selected patients who have a very high risk for cancer occurrence.”

“The risk for overall mortality is similar in patients with type 2 diabetes receiving glipizide, glyburide,or glimepiride monotherapy, according to the results of a retrospective cohort study, reported online March 9 in Diabetes Care. However, the findings suggest that glimepiride may be the preferred sulfonylurea in patients with underlying coronary artery disease (CAD).
Using an academic health center enterprise-wide electronic health record system, the investigators identified 11,141 patients with type 2 diabetes receiving sulfonylurea monotherapy who were at least 18 years old, with and without a history of CAD, and not taking insulin or a noninsulin injectable at baseline. Of these patients, 4279 had started monotherapy with glyburide, 4325 with glipizide, and 2537 with glimepiride.
Mortality rate was determined from the electronic health record and Social Security Death Index, and cohorts were compared with multivariable Cox models.
In the entire cohort, these agents did not differ significantly in the risk for overall mortality. In patients with documented CAD, however, there was a trend towards increased overall mortality risk with glyburide vs glimepiride (hazard ratio[HR], 1.36; 95% confidence interval [CI], 0.96 – 1.91) and glipizide vs glimepiride (HR, 1.39; 95% CI, 0.99 – 1.96).
On the basis of these findings, the investigators concluded that no increased mortality risk among the individual sulfonylureas was identified. However, they did suggest that glimepiride may be the preferred sulfonylurea in patients with underlying CAD.”

“The companies which have core focus on diabetes since the last 2-3 decades are mainly Elli Lilly, Novo Nordisk and Sanofi Aventis to name the major ones. Players of the mentioned i.e. Sanofi and Elli Lilly have placed their presence and footage in the other therapeutic areas of cancer, CNS to name a few. These companies have showcased their prospective drug pipelines at major events and conferences in the last few months. The objective of this showcasing is to invite outsourcing partners or licensing partners to carry out the strategic objectives and growth paths towards a next step. If the investor confidence during that period of showcasing is high then the forecasts for the drug coming to the market are elevated.
The companies are also engaged in separate ventures of taking their core focus areas like diabetes forward as well. One of the latest examples if of Sanofi which has recently entered into a US $335 million deal with a diabetic deal with CureDM, a USA based company.
With this deal, Sanofi Aventis get access to a novel human peptide, Pancreate, which could restore a patients’ ability to produce insulin.
Under the terms of the deal, the French drug maker could pay out up to $335 million (the size of the upfront payment has not been disclosed) to get an exclusive worldwide license for the treatment.
Pancreate (proisletide acetate) is a first-in-class bioactive peptide sequence of a naturally occurring human protein that has been shown in preclinical studies to stimulate the growth of new insulin producing islets in the pancreas and Phase I studies are planned for later this year.”

“The Diabetes major players like Novo Nordisk have declared their plans to the media that they would be launching their major and new diabetes products in the Indian market with a tie-up with Indian Pharma. Prospects for tie-Up are under review and the diabetes major has its entire plans for research in the European geographic region. The next 3 years will give European Research in diabetes a new dimension with the tie between European Foundation for the Study of Diabetes with Novo Nordisk. This will lend an extensive support to the diabetes major as an industry-academia partnership and will facilitate the EFSD to achieve further milestones in its commitment to diabetes research since its inception in 1999.
Veeda Clinical Research® is the first CRO to offer clients a specialised renal clinical pharmacology unit in India located in the Muljibhai Patel Urological Hospital (MPUH). MPHU is located approximately 40kms from Ahmedabad, the location of Veeda CR’s 116 bedded clinical pharmacology unit. MPHU is a premier institution providing health services in Urology and Nephrology including kidney transplantation and postgraduate education centre for DNB.
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The global diabetic market has been forecasted to grow to an estimated size of US$45bn growing at 8.5-9%. The reins of the overall market are vested with the USA and the EU where the combined geographic regions are forecasted to have a market share of 75% of the total market by the year 2015. The remaining market share would be occupied by the Rest of the world (primarily India) which accounts for 82% of the total world’s diabetic population and which would have a premium forecasted growth by the year 2015 despite a very low “”awareness””/””undetected “”diabetic population. For the US and the EU, although the awareness levels of the populations are extremely high, the known diabetic population numbers are less than 20% of the total population.
The conventional Diabetic drugs are the PPAR agonist which accounts for 46% of all oral /non –insulin diabetic drugs. DPP-4 inhibitors are novel class of inhibitors which accounts for 11.5% of the of all oral /non –insulin diabetic drugs in terms of revenue for the year 2008 and this scene is likely to dominate the forecasted revenue till the emergence of the “”newer”” therapies for diabetes in the next 10 years.
The total market for diabetes is dominated particularly insulin market is dominated by Novo Nordisk (50%), Elli Lilly (25%) and Sanofi Aventis (25%). The total market for Diabetes as a whole ( Insulin and non –insulin ) is dominated by Novo Nordisk ( 23%), Takeda ( 18%) , Sanofi Aventis( 15%), Elli Lilly( 12%), Merck (8%) and GSK (7%) i.e. in all a total of 6 major global players.
A graphical representation of the same is as follows:
Total Insulin Market Global

Total Diabetes Market Global

Veeda CR unit is familiar with a wide range of diabetology studies including euglycaemic and hyperglycaemic glucose clamping and assays such as insulin and glucagon, DPP inhibition and other enzymatic assays. We have access to populations of diabetics and pre-diabetics and the obese, clinically non-diabetic population.
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