Boston Therapeutics : to Start Clinical Trial in Type 2 Diabetes

October 11, 2011 - Boston Therapeutics, Inc., a public company registered with the SEC and a developer of diabetes therapeutics, announced the initiation of its first clinical trial to evaluate the Safety and Efficacy of PAZ320 when added to oral agents or Insulin regimen in Patients with Type 2 Diabetes Mellitus.

“We have already seen significant reduction of post-meal elevation of glucose in preclinical models with PAZ320,” said David Platt, Ph.D., Chief Executive Officer of Boston Therapeutics. “We are excited about our collaboration with Endocrinologist Sushela Chaidarun, M.D., Ph.D. and Dr. Laura E. Trask at Dartmouth Hitchcock Medical Center and the possibility to help millions of people with high blood sugar and diabetes.” 

PAZ320 is a chewable complex carbohydrate-based compound designed to reduce post-meal elevation of blood glucose. It is a proprietary polysaccharide designed to be taken before meals and works in the gastrointestinal system to block the action of carbohydrate-hydrolyzing enzymes which break down carbohydrates into glucose and release it into the bloodstream. This clinical study will evaluate the safety and efficacy of PAZ320 when added to oral diabetes agents or insulin. The study population will consist of adults aged 18-75 years with Type 2 diabetes, either on oral agents or insulin with a BMI of 25-35 kg/m2 and with A1c of less than 9.0%... [PDF] Boston Therapeutics' Press Release -

Merck : FDA Approves Merck's JUVISYNC™ (sitagliptin and simvastatin) Tablets, a Once-Daily Therapy for Patients with Type 2 Diabetes Who Need to Lower Blood Sugar and Cholesterol, Known Risk Factors for Cardiovascular Disease

Oct. 7, 2011 - Multiple National Guidelines Recommend that Patients with Type 2 Diabetes be Treated for Cholesterol - Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced that the U.S. Food and Drug Administration (FDA) has approved JUVISYNC™ (sitagliptin and simvastatin), a new treatment for type 2 diabetes that combines the glucose-lowering medication sitagliptin, the active component of JANUVIA® (sitagliptin), with the cholesterol-lowering medication ZOCOR® (simvastatin). JUVISYNC is the first treatment option for healthcare providers to help patients who need the blood sugar-lowering benefits of a DPP-4 inhibitor and the cholesterol-lowering benefits of simvastatin, with the convenience of a single tablet once daily. "Although clinical guidelines put people with type 2 diabetes who need glycemic and lipid therapy at the same risk level as those with coronary heart disease, nearly 40 percent of eligible patients do not receive statin treatment," said Barry J. Goldstein, M.D., Ph.D., vice president, Diabetes and Endocrinology, Merck. "We are proud to bring forward a treatment option that can help these patients who need both glycemic and lipid therapy."

Indications and usage for JUVISYNC

JUVISYNC is indicated in patients for whom treatment with both sitagliptin and simvastatin is appropriate. Sitagliptin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with coronary heart disease (CHD) or at high risk of CHD, simvastatin can be started simultaneously with diet... Merck' s Press Release -

Furiex Pharmaceuticals Confirms Takeda Launches LIOVEL® LD and LIOVEL® HD, a Fixed Dose Combination of NESINA® and ACTOS® for Type 2 Diabetes in Japan

September 20, 2011 - Furiex Pharmaceuticals, Inc. (Nasdaq: FURX) confirmed that Takeda Pharmaceutical Company Limited ("Takeda") has launched two dosages of LIOVEL®, a fixed dose combination tablet of NESINA® (alogliptin) and ACTOS® (pioglitazone HCL), in Japan for the treatment of Type 2 diabetes.

Furiex developed NESINA, which is a member of the dipeptidyl peptidase IV (DPP-4) inhibitor class, in collaboration with Takeda's wholly-owned subsidiary, Takeda San Diego, Inc. LIOVEL LD and LIOVEL HD contain 25 mg alogliptin/15 mg pioglitazone and 25 mg alogliptin/30 mg pioglitazone, respectively.

"We are very pleased with Takeda's launch of LIOVEL in Japan, a new product using the drug NESINA," said June Almenoff, M.D., Ph.D., president and chief medical officer of Furiex. "This launch adds to Furiex's revenue stream and confirms our strategy of partnering drug candidates in return for royalty payments." 

Under Furiex's agreement with Takeda, this launch does not trigger a milestone payment to Furiex. However, Furiex is entitled to receive royalty payments on sales of LIOVEL... Furiex Pharmaceuticals' Press Release - Takeda Pharmaceutical's Press Release -