Diabetic Ketoacidosis News and Research

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Diabetic ketoacidosis – (DKA) or diabetic coma occurs when a diabetic does not properly balance their insulin intake with their diet or activity.

Positive results from exenatide phase 2 study in patients with type 2 diabetes

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. today announced positive results from a phase 2 study evaluating the effects of a once-monthly injectable suspension formulation of exenatide on glycemic control in patients with type 2 diabetes.

10 Mar 2011

Merck to present VICTRELIS phase III study data against HCV at EASL annual meeting

Merck, known as MSD outside of the United States and Canada, announced that several new data analyses from Phase III studies of VICTRELIS, its investigational oral hepatitis C protease inhibitor, will be presented at The International Liver CongressTM / 46th European Association for the Study of the Liver annual meeting.

9 Mar 2011

FDA approves ONGLYZA to treat type 2 diabetes patients with renal impairment

Bristol-Myers Squibb Company and AstraZeneca today announced that the U.S. Food and Drug Administration has approved the inclusion of data from two clinical studies in an update to the ONGLYZA U.S. Prescribing Information for adult type 2 diabetes patients.

24 Feb 2011

Diabetes Management – a new journal addressing the management issues of a complex disease

Future Medicine Ltd has today announced the launch of Diabetes Management – a new bimonthly title presenting findings, analyses and commentaries on the battle with Type 1 and Type 2 diabetes. Diabetes Management is published by Future Medicine Ltd (UK, London) renowned for its collection of journals providing healthcare practitioners and research professionals with a unique source of objective, cutting-edge information on exciting trends emerging in light of advances in medicine, healthcare and clinical practice.

6 Feb 2011

FDA accepts Merck's JANUMET extended-release formulation NDA for type 2 diabetes

Merck today announced that the New Drug Application (NDA) for the Company's investigational extended-release formulation of JANUMET for type 2 diabetes has been accepted for standard review by the U.S. Food and Drug Administration (FDA). The Company is also moving forward as planned with regulatory filings in countries outside the United States.

12 Jan 2011

FDA approved KOMBIGLYZE XR for type 2 diabetes mellitus now available in pharmacies

Bristol-Myers Squibb Company, and AstraZeneca today announced that KOMBIGLYZE™ XR (saxagliptin and metformin HCl extended-release), approved by the U.S. Food and Drug Administration (FDA) on November 5, 2010, is now available by prescription in pharmacies across the United States.

7 Jan 2011

GLUMETZA tablets are now available to wholesalers and physicians

Santarus, and Depomed, today announced that supply of GLUMETZA® 500 mg to wholesalers and retailers has resumed. GLUMETZA is a once-daily, extended release formulation of metformin and is approved for use in adults with type 2 diabetes mellitus.

5 Jan 2011

Amylin, Lilly submit BYETTA sNDA for type 2 diabetes

Amylin Pharmaceuticals, Inc. and Eli Lilly and Company today announced that a supplemental New Drug Application (sNDA) has been submitted to the U.S. Food and Drug Administration (FDA) for the expanded use of BYETTA® (exenatide) injection as an add-on therapy to basal insulin, with or without metformin and/or a thiazolidinedione (TZD) in conjunction with diet and exercise for adults with type 2 diabetes who are not achieving adequate glycemic control.

23 Dec 2010

Takeda completes settlements in patent litigation over generic ACTOS, ACTOplus met, and duetact ANDAs

Takeda Pharmaceutical Company Limited ("Takeda") today announced that Takeda and its wholly-owned subsidiary, Takeda Pharmaceuticals North America, Inc. ("TPNA"), have completed settlements with all defendants in patent litigation brought against the companies in response to their Abbreviated New Drug Applications ("ANDAs") for generic ACTOS® (pioglitazone HCl), ACTOplus met® (pioglitazone HCl and metformin HCl), and duetact® (pioglitazone HCl and glimepiride).

22 Dec 2010

Santarus announces commercial U.S. launch of CYCLOSET for type 2 diabetes mellitus

Santarus, Inc., a specialty biopharmaceutical company, today announced the commercial U.S. launch of CYCLOSET (bromocriptine mesylate) tablets. CYCLOSET is a prescription drug approved by the U.S. Food and Drug Administration (FDA) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus both as monotherapy and in combination with other oral antidiabetic agents.

15 Nov 2010

FDA issues complete response letter for BYDUREON NDA

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (NDA) for BYDUREON™ (exenatide extended-release for injectable suspension).

21 Oct 2010

Takeda underscores commitment to ACTOS following FDA and EMA announcements for rosiglitazone

Following today’s announcements by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for rosiglitazone in the U.S. and Europe, Takeda Pharmaceuticals North America, Inc. and Takeda Pharmaceuticals Europe Limited underscore the company’s commitment to ACTOS® (pioglitazone HCl) and ACTOS-containing medications, and to the millions of people living with type 2 diabetes.

24 Sep 2010

Type 1 diabetes, early recognition, telltale signs

Though they may present in a similar fashion, type 1 diabetes mellitus is vastly different from type 2, and Ralph Schmeltz, MD, incoming president of the Pennsylvania Medical Society, says it’s important to recognize and diagnose it early.

23 Sep 2010

Sanofi-aventis releases Lantus(R) study results for type 2 diabetes

Sanofi-aventis announced today results of two studies presented at the European Association for the Study of Diabetes (EASD) 46th Annual Meeting in Stockholm, Sweden.

20 Sep 2010

ACTOS offers safety profile regarding risk of CV events in people with type 2 diabetes: Takeda

The U.S. Food and Drug Administration Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee held a joint meeting primarily focused on reviewing the cardiovascular safety of rosiglitazone, as presented by the FDA and GlaxoSmithKline. Following this two day discussion, Takeda Pharmaceuticals North America, Inc. ("Takeda") underscores its position that ACTOS (pioglitazone HCl) offers an established safety profile regarding the risk of CV events in people living with type 2 diabetes.

16 Jul 2010

Study: ONGLYZA and metformin improve HbA1c levels for adult patients with type 2 diabetes at 76-weeks

Bristol-Myers Squibb Company and AstraZeneca today announced results up to 76-weeks from a Phase 3 study of ONGLYZA(TM) (saxagliptin) as initial combination therapy with metformin, which produced long-term glycemic improvement (as measured by glycosylated hemoglobin level (HbA1c)) in treatment-naive adults with type 2 diabetes mellitus inadequately controlled on diet and exercise compared to treatment with an investigational 10 mg dose of saxagliptin or metformin alone.

2 Jul 2010

Amylin presents improved indices of beta-cell function after three years of BYETTA(R) therapy

Amylin Pharmaceuticals, Inc. and Eli Lilly and Company today announced results from a study comparing the effect of long-term treatment with either BYETTA® (exenatide) injection or Lantus® (insulin glargine) on overall beta-cell function. (Beta cells are cells in the pancreas that produce insulin.) Three years of BYETTA therapy improved indices of beta-cell function assessed four weeks after discontinuing therapy. These findings were presented at the 70th Annual Scientific Sessions of the American Diabetes Association (ADA) in Orlando, Fla.

30 Jun 2010

Welchol plus metformin combination therapy reduces A1C, LDL-C levels in type 2 diabetes patients

Results of a new study demonstrated that initial combination therapy with Welchol® (colesevelam HCl) 3.75 g/d and metformin (initiated at 850 mg/d; uptitrated to 1700 mg/d thereafter) significantly improved glycemic and lipid control in drug-naive adult type 2 diabetes patients with high LDL cholesterol (LDL-C).

29 Jun 2010

First placebo-controlled clinical study results of BYETTA injection with Lantus presented at ADA 2010

Amylin Pharmaceuticals, Inc. and Eli Lilly and Company today announced results from the first double-blind, placebo-controlled clinical study to evaluate BYETTA (exenatide) injection added to Lantus (insulin glargine), which showed patients with type 2 diabetes achieved glucose targets without weight gain or increasing their risk of hypoglycemia. These findings were presented at the 70th Annual Scientific Sessions of the American Diabetes Association in Orlando, Fla.

28 Jun 2010

JANUMET results in greater blood sugar reductions in patients with type 2 diabetes compared to pioglitazone

New data were presented at the American Diabetes Association 70th Annual Scientific Sessions from a study comparing JANUMET (sitagliptin/metformin) to pioglitazone. In this study, JANUMET resulted in significantly greater blood sugar reductions in patients with type 2 diabetes compared with pioglitazone.