KineMed and Daiichi Sankyo : New Discovery of Key Difference in Bile Acid Metabolism in Patients With Type 2 Diabetes May Suggest Underlying Disorder

June 9, 2008 - KineMed, Inc. and Daiichi Sankyo, Inc. announced that researchers have discovered a key difference in bile acid metabolism in people with type 2 diabetes which may suggest a newly identified underlying disorder.

It has long been known that bile acids help the body absorb fat and cholesterol. In the last decade, we learned that bile acids are important signaling molecules that regulate the metabolism of glucose, fat, and energy. And until now, there has been only preliminary data suggesting alterations in bile acid metabolism in people with type 2 diabetes. Now new data highlight crucial alterations in bile acid metabolism in this population. Researchers reported results from the first controlled study addressing this issue, which they hope will lead to a better understanding of how bile acid metabolism is impacted in people with type 2 diabetes.

The study found that the most important bile acid, cholic acid (CA), had a significantly higher synthesis rate in people with type 2 diabetes than in patients with normal glucose levels. Researchers also learned that the rate at which deoxycholic acid (DCA) was recycled back into the liver (i.e. DCA input rate) was almost twice as great in those with type 2 diabetes as in the healthy subjects. In addition, the total amount of bile acid synthesized by the liver was elevated, although not statistically significantly, in people who have type 2 diabetes as compared to the healthy control group... [PDF] Daiichi Sankyo's Press Release -

Tranzyme Pharma to Present “Ghrelin Agonist (TZP-101) Effects on Patients with Severe Symptomatic Diabetic Gastroparesis” at ADA 2008

June 5, 2008 - Tranzyme Pharma, a leading biopharmaceutical company that discovers and develops small molecule drugs for the treatment of gastrointestinal and metabolic diseases, announced that Dr. Niels Ejskjaer, MD, PhD of Aarhus University Hospital, Denmark, will present Phase IIa trial results of Tranzyme’s first-in-class ghrelin agonist TZP-101 at the American Diabetes Association, 68th Annual Meeting to be held in San Francisco, CA, June 6-10, 2008.
Using scintigraphy and a standardized radiolabeled meal, this double blind, randomized, two-way crossover study assessed the effects of TZP-101 on gastric emptying in 10 patients with long standing type 1 or type 2 diabetes and severe symptomatic gastroparesis... Tranzyme Pharma's Press Release -

Speedel : SPP100 (TEKTURNA/RASILEZ) DEMONSTRATES POTENTIAL TO PROTECT KIDNEYS FROM DAMAGE

4 June 2008 - Data from the AVOID study published in the New England Journal of Medicine demonstrate that the first-in-class direct renin inhibitor Rasilez®1 (aliskiren), known as Tekturna®[1] in the US, may have potential kidney-protective benefits that are independent of its already proven ability to provide powerful blood pressure reductions[2],[4]. AVOID is the first substantial clinical trial to present data on potential kidney-protective benefits of Rasilez[1]. Damage to the kidneys caused by diabetes is the leading cause of end-stage renal disease in developed countries, affecting more than 1.5 million people worldwide[2],[5].

In the AVOID study, Rasilez/Tekturna1 reduced albuminuria, a key indicator of kidney disease, by an additional 20% in type 2 diabetic patients with kidney disease who also had a diagnosis of high blood pressure. These patients were already taking the maximum dose of the angiotensin-receptor blocker (ARB) losartan, which has been shown to slow the progression of diabetic kidney disease[2],[6].

In patients with diabetes, the first sign of kidney disease is the presence of albumin in the urine, a condition called albuminuria[3]. Albuminuria is a key indicator of kidney disease and cardiovascular disease[3]. Reducing albuminuria is associated with a reduction of cardiovascular events[7] and slows the progression of kidney disease, which can reduce the risk of chronic kidney failure in type 2 diabetic patients with kidney disease and high blood pressure[8],[9]... Speedel's Press Release -

Novo Nordisk and Sciele Pharma : FDA Approves PrandiMet, a Replaglinide and Metformin Fixed Dose Combination Tablet for Treatment of Type 2 Diabetes

June 24, 2008 - Sciele Pharma, Inc. (NASDAQ:SCRX) and Novo Nordisk Inc. announced that the U.S. Food and Drug Administration (FDA) approved PrandiMet(TM) (repaglinide and metformin HCl) tablets, the first and only fixed-dose combination of the fast-acting secretagogue replaglinide (also known as Prandin(R)) and insulin sensitizer, metformin, for the treatment of type 2 diabetes.
Under a previously announced agreement, Sciele Pharma will exclusively market PrandiMet(TM) to physicians in the U.S. Sciele Pharma anticipates that PrandiMet(TM) will be available to physicians and patients in the U.S. in the second half of 2008.

PrandiMet(TM) has been approved to lower the blood glucose in adult patients with type 2 diabetes whose hyperglycemia cannot be controlled satisfactorily by meglitinide and/or metformin... Sciele Pharma's Press Release - Novo Nordisk's Press Release -

SurModics : Initiation by Merck & Co., Inc. of Phase IIb Clinical Trial for I-vation TA

Jun 25, 2008 - SurModics, Inc. (Nasdaq: SRDX), a leading provider of surface modification and drug delivery technologies to the healthcare industry, announced the initiation by Merck & Co., Inc. of a Phase IIb clinical trial to evaluate the safety and efficacy of SurModics' I-vation(TM) TA in patients with diabetic macular edema.
The initiation of this Phase IIb trial triggers a milestone payment of $9 million from Merck to SurModics under the companies' License and Research Collaboration Agreement announced in June 2007... SurModics' Press Release -

OSI Pharmaceuticals : Diabetes/Obesity Preclinical Compounds, PSN821 and PSN602, at Annual Meeting of the American Diabetes Association

June 10, 2008 - OSI Pharmaceuticals, Inc. (Nasdaq: OSIP) provided an informational update on data from its two preclinical development compounds, PSN821 and PSN602. This information was presented at the annual meeting of the American Diabetes Association in San Francisco, CA. Preclinical data on PSN821, a novel, orally available agonist of the G-protein coupled receptor GPR119, being developed for the treatment of type 2 diabetes and obesity, were presented in an oral presentation. Also presented were preclinical data on PSN602, an oral dual serotonin and norepinephrine reuptake inhibitor and 5-HT1A agonist, being developed for the treatment of obesity. Both compounds are due to enter Phase I clinical trials in 2008... OSI Pharmaceuticals' Press Release -

Osiris Therapeutics : $2 Million Milestone Payment for Clinical Progress of a Stem Cell Therapy for Type 1 Diabetes

6-25-08 - Osiris Therapeutics, Inc. (NASDAQ:OSIR) announced that it has achieved $2 million in milestone payments from the Juvenile Diabetes Research Foundation (JDRF) for progress made on a Phase II clinical trial evaluating Prochymal, a mesenchymal stem cell (MSC) therapy, for patients recently diagnosed with type 1 diabetes. The payments were triggered when Osiris accomplished certain clinical and regulatory milestones including initiating patient treatments... Osiris Therapeutics' Press Release -

Melior : Option Agreement with Pfizer

June 24, 2008 -Melior Discovery, Inc. announced that it has signed an option agreement that provides Pfizer Inc the exclusive right to negotiate a license to MLR-1023, Melior’s drug candidate for Type II diabetes. In exchange, Pfizer agreed to make an undisclosed payment to Melior and provide access to certain data it owns related to MLR-1023.
In addition, Melior agreed to utilize its in-vivo theraTRACE® indications discovery platform to evaluate the activity of selected Pfizer compounds in partnership with Pfizer... [PDF] Melior Discovery's Press Release -

Nastech : Positive Intranasal Insulin Data at American Diabetes Association Meeting

June 9, 2008--Nastech Pharmaceutical Company Inc. (Nasdaq: NSTK) announced data from a Phase II clinical trial demonstrating that its ultra rapid acting intranasal insulin was both superior to usual therapy (oral anti-diabetic medicines and/or basal insulin) and non-inferior to insulin aspart (NovoLog(R)), a rapid-acting injectable insulin, in maintaining glucose control at both 60 and 90 minutes following a meal. The data also demonstrated a statistically significant reduction in the incidence of hypoglycemia (low blood sugar less than 70 mg/dL) compared with insulin aspart in the four hours following the meal. The data were reported at the 68th Scientific Sessions meeting of the American Diabetes Association in San Francisco in an oral presentation by Professor Lutz Heinemann, Ph.D., of the Profil Institute for Metabolic Research Ltd., and in a Nastech poster presentation... Nastech Pharmaceutical's Press Release -

CytRx : Favorable Study Data with Iroxanadine in Diabetic Wound Healing at the Third Congress of the World Union of Wound Healing Societies

June 2, 2008 - CytRx Corporation (Nasdaq:CYTR), a biopharmaceutical company engaged in the development and commercialization of human therapeutics, announced that on June 6, 2008 it will present study data indicating that diabetic mice treated with iroxanadine healed from diabetic wounds nearly two times faster than untreated diabetic mice. These study results will be introduced by CytRx's Senior Vice President of Research and Development Shi Chung Ng, Ph.D., at the Third Congress of the World Union of Wound Healing Societies held in Toronto, Canada.

During his presentation, Dr. Ng will discuss the method of action of iroxanadine, which is believed to repair damaged endothelial cells by amplifying molecular chaperones. Molecular chaperones are proteins that recognize for repair or mark for destruction other proteins that have misfolded in inappropriate, toxic shapes during conditions that are stressful to cells, such as during certain disease states. Small molecule amplifiers of the chaperone response, such as CytRx's clinical candidates iroxanadine and arimoclomol, have shown promising results in animal models of neurological impairment and diabetic complications... CytRx's Press Release -

AVANIR : Grant of New Zenvia Patent

Jun 19, 2008 - Extends Period of Commercial Exclusivity in Europe into 202 - AVANIR Pharmaceuticals (NASDAQ:AVNR) announced that the European Patent Office (EPO) has granted AVANIR a new patent, extending the period of commercial exclusivity for its lead drug candidate Zenvia™ (dextromethorphan/quinidine) into 2023.

EPO patent number 1.539.166 titled "Pharmaceutical Compositions Comprising Dextromethorphan and Quinidine for the Treatment of Neurological Disorders" will be published in the European Patent Bulletin on July 2, 2008 and will be effective on that date. The new European patent expands the available Zenvia dose ranges under prior patent protection and encompasses the Company's current clinical development programs in pseudobulbar affect (PBA) and diabetic peripheral neuropathic (DPN) pain, as well as other neurologic conditions... AVANIR Pharmaceuticals' Press Release -

Tethys Bioscience : Expanded Availability of PreDx Diabetes Risk Test

2008-Jun-07 — Tethys Bioscience, Inc. announced at the 68th Scientific Sessions of the American Diabetes Association (ADA) that it has expanded the availability of its novel PreDx™ Diabetes Risk Test, a first-of-its-kind predictive tool that delivers an accurate assessment of an individual's risk of developing Type 2 diabetes within the next five years. The test is performed exclusively by the Tethys Bioscience Clinical Laboratory on routinely collected blood samples.
The new blood test is designed to help physicians identify patients at highest risk of developing Type 2 diabetes so that they can promote lifestyle changes or initiate treatment plans to prevent or slow progression to Type 2 diabetes. Numerous studies have demonstrated that such interventions can reduce the incidence of new onset diabetes by 30-60%... Tethys Bioscience's Press Release -

Antigen Express and Generex Biotechnology : Blood Test for Type-1 Diabetes Coming Soon

Jun 10, 2008 - A new test to identify cases of type 1 diabetes may soon be available thanks to technological advances.

The technology has been developed by Antigen Express, the wholly-owned subsidiary of NASDAQ-listed oral insulin delivery company Generex Biotechnology.

Currently, Type I diabetes can only be diagnosed by the presence of antibodies when the disease is already well underway.

Investigators were aware of Antigen Express technology whereby antigenic peptides linked to the "Ii-key" fragment of the MHC class II associated invariant chain enhances the presentation of those antigenic peptides.
Ii-Key/peptide 'hybrids' are able to bind directly to MHC class II molecules on the test cell's surface, thus obviating the need for antigen internalization within cells.

Earlier studies indicated that chemically linking the antigenic peptide to Ii-key through a flexible chemical linking agent could improve recognition of antigens, and may lead to a rapid, reliable assay for individuals with, or at risk for, Type-1 diabetes.

The antigen used in the study was GAD65, a protein that frequently triggers the autoimmune response in some diabetics. Researchers linked an antigenic peptide derived from GAD65 to the Ii-Key fragment, which is known to enhance presentation and binding of antigenic peptides directly to MHC Class II receptors on the cell surface... Generex Biotechnology's Press Release -

Roche : investigational diabetes drug, Taspoglutide, into Phase III clinical trials

10 June 2008 - Positive Phase II results of Roche and Ipsen’s first once-weekly human GLP-1 presented at the American Diabetes Association congress -
Roche and Ipsen’s investigational diabetes drug taspoglutide has been shown to be generally well-tolerated and efficacious for the treatment of patients with type 2 diabetes, resulting in significant improvements in glucose control and weight loss after only eight weeks of treatment.1,2, Taspoglutide, the first human once weekly glucagon-like peptide-1 (GLP-1) analogue originating from Ipsen’s Research, is a compound similar to the natural hormone GLP-1 which has a key role in blood sugar regulation.
Based on these promising Phase II results, presented at the American Diabetes Association (ADA) in San Francisco, U.S., Roche has made the decision to move taspoglutide into Phase III clinical trials with the programme anticipated to start in the second half of 2008... Roche's Press Release - [PDF] Ipsen’s Press Release -

LCT : Diabetes Clinical Trial

June 5, 2008 - Living Cell Technologies Limited (ASX:LCT; OTC: LVCLY) announced that the positive preliminary data from its first clinical trial of Diabecell® for insulin dependent type 1 diabetes has encouraged the Company to expand the trial and proceed with testing higher doses.
In LCT’s first Phase I/IIa trial of DiabeCell®, its lead product of encapsulated porcine insulin producing cells, 5 patients have been implanted with the lowest dose. As reported in the Company’s clinical update on 31 March 2008, there have been no significant adverse effects and a clinical effect was demonstrated with reduction in daily insulin requirement for up to six months follow up with satisfactory control of blood glucose... [PDF] Living Cell Technologies' Press Release -

VeraLight Plans FDA Submission of Non-invasive Diabetes Screening Device By Year End

June 3, 2008 — VeraLight, Inc., a privately held medical device company, announced the completion of a Series C financing that will provide up to $20 million to complete the company’s pivotal clinical trial, and gain worldwide commercialization and adoption of the VeraLight
SCOUT DS™ non-invasive diabetes screening system. The current round of funding was led by the Psilos Group and CMEA Ventures, with participation by vSpring Capital, EPIC Ventures, The Dow Chemical Company, and the Southern Ute Growth Fund.
The company also announced it plans to submit a Premarket Approval application to the U.S. Food and Drug Administration by the end of this year to evaluate the safety and effectiveness of the SCOUT DS for marketing clearance... [PDF] VeraLight's Press Release -

VistaGen Licenses Customized Stem Cell-Based Drug Discovery Assays to Sanwa, a Japanese

May 22, 2008 — VistaGen Therapeutics, Inc., a biotechnology company using leading-edge embryonic stem cell (ES Cell) technologies for predictive toxicology and drug discovery, announced that Sanwa Kagaku Kenkyusho Co. Ltd. (Sanwa), an international pharmaceutical company headquartered in Nagoya, Japan, has, pursuant to the terms of the parties’ joint research an development agreement, selected to license three customized ES Cell-based beta-islet differentiation assay systems developed under the agreement. Financial terms were not disclosed.
Sanwa will use these customized ES Cell assays to identify and screen new diabetes drug candidates.


The assay systems were developed to expand the capabilities of VistaGen's ES Cell technologies to discover novel biologic products to treat diabetes and to accelerate Sanwa's internal discovery and screening programs for new small molecule drug candidates for Type 1 and Type 2 diabetes... [PDF] VistaGen Therapeutics' Press Release -

Sanofi-aventis : Acomplia (rimonabant) significantly improved glucose control in type 2 diabetes patients treated with insulin

June 10, 2008 - Sanofi-aventis announced the results of ARPEGGIO, the first trial of rimonabant in patients with type 2 Diabetes, not adequately controlled with insulin therapy. These results were presented today at the 68th Scientific Sessions of the American Diabetes Association, in San Francisco.
Rimonabant 20 mg significantly improved HbA1c (a standard blood measure value that is indicative of a patients’ glucose for about two months) by 0.89% from the baseline value, and 0.64% over the control group. Glucose control was three times more pronounced when rimonabant was added than insulin and lifestyle advice alone.
The 368 type 2 diabetes patients participating to this 11-month trial had been treated with insulin for an average duration of six years prior to entering the study... [PDF] Sanofi-aventis' Press Release -

LifeScan and ResMed : Co-Marketing Agreement Focused on Treatment of Type 2 Diabetes and Sleep-Disordered Breathing

June 10, 2008 – LifeScan, Inc., maker of the leading OneTouch® Brand of blood glucose meters for people with diabetes, and ResMed, Inc. (NYSE: RMD), a leading manufacturer of medical devices for the diagnosis and treatment of sleep apnea, today announced an exclusive co-marketing agreement designed to improve the lives of people with type 2 diabetes and sleep-disordered breathing (SDB). The joint work of the two companies will focus on educational and cross-promotional efforts intended to benefit the patients and healthcare professionals served by both companies.
The goal is to build awareness among healthcare professionals of the overlap of these two conditions, trigger new approaches to patient care, and ultimately improve the rate of treating patients suffering from both SDB and diabetes... LifeScan's Press Release -

AstraZeneca & Bristol-Myers Squibb : ONGLYZA™ (saxagliptin) demonstrated significant reductions in key measures of glucose control in treatment ...

June 7, 2008 – Results from a 24-week Phase III study presented at the 68th American Diabetes Association Annual Scientific Sessions demonstrated that saxagliptin, a selective, reversible inhibitor of the dipeptidyl peptidase (DPP-4) enzyme in development by Bristol-Myers Squibb Company (NYSE: BMY) and AstraZeneca (NYSE: AZN), produced significant reductions in key measures of glucose control (glycosylated hemoglobin level [A1C], fasting plasma glucose [FPG] and postprandial glucose [PPG]) in treatment naïve people with type 2 diabetes compared to placebo (PBO).
Over 24 weeks, saxagliptin had an adverse event profile that appeared similar to placebo. The companies have proposed the trade name ONGLYZA™ for saxagliptin if approved by the U.S. Food & Drug Administration... AstraZeneca's Press Release - Bristol-Myers Squibb's Press Release -

MDS Pharma : Therapeutic Focus Metabolic Disorders

May 20, 2008 - MDS Pharma Services, a leading provider of innovative drug discovery and development solutions, has named two experienced medical professionals to lead its late stage clinical trial management activities related to respiratory ailments and metabolic disorders. Dr. Bernard Tisserand and Dr. Jonny L. Salyer have been named Executive Medical Directors for Respiratory Disorders and Metabolic Disorders, respectively. These therapeutic areas represent serious global public health concerns and are key areas of focus for MDS Pharma Services' customers. Respiratory disorders include conditions such as asthma, allergic rhinitis, chronic obstructive pulmonary disease (COPD), and community acquired pneumonia (CAP), while metabolic disorders include diabetes, dyslipidemia, obesity and metabolic syndrome, which is defined as a cluster of conditions that damage the cardiovascular system... MDS Pharma Services' Press Release -

Amylin Pharmaceuticals : Promising Data From Diabetes and Obesity Programs at ADA 2008

June 2, 2008, 2008 - Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) announced that the company will present new data for its FDA-approved diabetes drugs, BYETTA(R) (exenatide) injection and SYMLIN(R) (pramlintide acetate) injection, and its pipeline diabetes and obesity drug candidates at the American Diabetes Association's 68th Annual Scientific Sessions (ADA) being held in San Francisco, CA from June 6 to 10. The company will also host an investor presentation on Sunday, June 8, at 7:45 PM PT (10:45 PM ET) that will be available by webcast. ADA is one of the largest scientific meetings for endocrinologists and other health care professionals involved in diabetes research and the delivery of diabetes care.

Amylin will be introducing data through over 20 posters and eight oral presentations at the meeting. The data will demonstrate significant progress in key research and clinical programs that include studies of BYETTA, SYMLIN, and Amylin's early and late-stage pipeline candidates... Amylin's Press Release -

Novo Nordisk files for regulatory approval of liraglutide in both the US and Europe

May 23, 2008 - Novo Nordisk announced the submission of a New Drug Application (NDA) to the Food and Drug Administration (FDA) in the US as well as a marketing authorisation application to the European Medicines Agency (EMEA) in Europe, for the approval of liraglutide, a once-daily human GLP-1 analogue, for the treatment of people with type 2 diabetes. Both the US and the European applications contain documentation from an extensive clinical development programme that included around 6,500 people of which approximately 4,200 received liraglutide. The programme was designed to obtain the indication for use of liraglutide to treat type 2 diabetes as an adjunct to diet and exercise, both as monotherapy and in combination with commonly used antidiabetic medications... Novo Nordisk's Press Release -

MacroChem : Presentation by Michael Zasloff, MD, PhD on Topical Therapy for Diabetic Foot Infection

June 5, 2008 - MacroChem Corporation (OTC Bulletin Board: MACM) announced that Michael Zasloff, MD, PhD , Professor, Department of Surgery, Georgetown University, a pioneer in the discovery of antimicrobial peptides and a member of MacroChem's Scientific Advisory Board, will make a presentation entitled "Topical Therapy for Infections: Are Peptides Ready for Prime-Time?" at a symposium entitled New Developments in Diabetic Foot Wound Assessment and Treatment at the 68th Scientific Session of the American Diabetes Association in San Francisco on June 8, 2008 at 2:30 pm local time.

Dr. Zasloff will discuss recent discoveries in innate immunity that explain the role of antimicrobial peptides in protecting human skin from infection. In this context, he will discuss the rationale for the development of a topical antimicrobial peptide for the treatment of infected diabetic foot ulcers. This condition remains a leading complication of diabetes, resulting in thousands of lower limb amputations yearly... MacroChem's Press Release -

Merck : New Data Released at Major Diabetes Meeting on Initial Combination Therapy with JANUVIA (sitagliptin), Merck's Diabetes Medicine, & Metformin

June 7, 2008 - New data presented at the American Diabetes Association (ADA) 68^th Annual Scientific Sessions showed initial combination therapy with JANUVIA™ (sitagliptin), a diabetes medicine from Merck & Co., Inc., and metformin substantially improved markers of beta cell function and significantly reduced blood sugar levels (as measured by A1Cⁱ) at one year and two years.

JANUVIA is indicated, as an adjunct to diet and exercise, to improve glycemic control in adult patients with type 2 diabetes. JANUVIA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. JANUVIA has not been studied in combination with insulin. JANUVIA is contraindicated for patients with history of a serious hypersensitivity reaction to sitagliptin, including anaphylaxis and angioedema... Merck's Press Release -

Amylin, Lilly and Alkermes : Type 2 Diabetes Patients Taking Exenatide Once Weekly, a Phase 3 Investigational Diabetes Therapy, Showed Improvements

June 7, 2008 - Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY), and Alkermes, Inc. (Nasdaq: ALKS) announced results from a 30-week study that compared the efficacy of exenatide once weekly, a long-acting release formulation of exenatide, to BYETTA® (exenatide) injection.
Type 2 diabetes patients treated with exenatide once weekly, an investigational therapy, showed statistically significant improvements in A1C (-1.9%+/-0.08 (LS mean+/-SE)) and fasting plasma glucose (FPG -42+/-3 mg/dL) from baseline and compared with BYETTA (-1.5%+/-0.08, A1C and -25+/-3 mg/dL, FPG).
Patients in both treatment groups also reported significant weight loss (average of 8 pounds) and 77 percent of patients treated with exenatide once weekly achieved an A1C of 7 percent or less.
These findings were presented at the 68th Annual Scientific Sessions of the American Diabetes Association (ADA) in San Francisco... Lilly's Press Release - Alkermes' Press Release -

Takeda : Voglibose (BASEN) for the prevention of type 2 diabetes mellitus

May 26, 2008 - Takeda Pharmaceutical Company Limited (“Takeda”) announced that, on May 24 at the 51st Annual Meeting of the Japan Diabetes Society, the data from a phase 3 clinical study to evaluate the effects of BASEN^® (generic name: voglibose) on prevention of onset of type 2 diabetes mellitus in subjects with impaired glucose tolerance (“IGT”) was presented. The data represents the first clinical evidence with Japanese subjects that showed preventive effects by medicinal treatment of type 2 diabetes, when being added on the dietary treatment and/or exercise therapy.
BASEN was launched in 1994 in Japan as an improving agent for postprandial hyperglycemia in diabetes mellitus. Based on the data presented this time, Takeda submitted on December 18, 2007 an application to the Ministry of Health, Labour and Welfare in Japan for an additional indication of “BASEN^® Tablets 0.2” and “BASEN^® OD Tablets 0.2” for prevention of onset of type 2 diabetes in patients with IGT... Takeda's Press Release -

Amylin and Lilly : Monotherapy BYETTA (exenatide) Injection Study Results Presented at ADA 2008 Showed Adults with Type 2 Diabetes Experienced...

June 7, 2008 - Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Eli Lilly and Company (NYSE: LLY) announced additional results from a study of patients with type 2 diabetes who were unable to achieve glycemic control through diet and exercise alone and were treated with either monotherapy (stand-alone) BYETTA® (exenatide) injection taken twice daily or placebo. Study findings showed that patients treated with monotherapy exenatide showed statistically significant improvement in both A1C and weight loss with a lower incidence of nausea than in previous exenatide studies. Exenatide is indicated as adjunctive therapy to improve glycemic control in patients with type 2 diabetes mellitus who are taking metformin, a sulfonylurea, a thiazolidinedione, a combination of metformin and a sulfonylurea, or a combination of metformin and a thiazolidinedione, but have not achieved adequate glycemic control. These findings were presented at the 68th Annual Scientific Sessions of the American Diabetes Association (ADA) in San Francisco... Lilly's Press Release -

sanofi-aventis : Study Shows LANTUS Helped People Living with Type 2 Diabetes Reach the ADA’s Recommended Target for Blood Sugar Control

June 7, 2008 - Results from a new study presented at the American Diabetes Association's (ADA) 68th Annual Scientific Sessions reinforce the importance of promptly initiating insulin treatment when patients with type 2 diabetes are unable to achieve recommended glycemic targets with diet, exercise and oral diabetes medications alone. In the TULIP (Testing the Usefulness of Lantus(R) when Initiated Promptly in patients with type 2 diabetes) clinical study, 66 percent of patients who began treatment with the long-acting, basal insulin Lantus(R) (insulin glargine [rDNA origin] injection) achieved A1C <7%, style="text-decoration: underline;"> [PDF]sanofi-aventis' Press Release -