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.

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.

28 Jun 2010

Data shows Victoza produces greater reductions in A1c, body weight and FPG than Januvia

Late-breaking Novo Nordisk extension data presented today at the 70th Annual Scientific Sessions of the American Diabetes Association showed that once-daily Victoza in combination with metformin produced sustained and significantly greater reductions in A1c, body weight and fasting plasma glucose than Januvia plus metformin at 52 weeks.

28 Jun 2010

Data on BYETTA and SYMLIN injections, BYDUREON drug candidate to be presented at ADA 2010

Amylin Pharmaceuticals, Inc. today announced that the Company will present data for its FDA-approved diabetes drugs, BYETTA (exenatide) injection and SYMLIN (pramlintide acetate) injection, and its investigational diabetes drug candidate BYDUREON (exenatide extended-release for injectable suspension) at the American Diabetes Association's 70th Annual Scientific Sessions being held in Orlando, FL from June 25 to June 29.

18 Jun 2010

DURATION-4 study tests superiority of BYDUREON as compared to other type 2 diabetes medications

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. today announced results from DURATION-4, the fourth in a series of studies designed to test the superiority of BYDUREON (exenatide extended-release for injectable suspension), an investigational type 2 diabetes therapy, as compared to other type 2 diabetes medications.

18 Jun 2010

Health Canada approves Victoza for treatment of adults with type 2 diabetes

Diabetes is growing at an alarming rate in Canada, with an estimated 3.7 million people expected to be diagnosed by 2020. It is a progressive disease that, if not properly monitored and managed over time, will lead to serious long term complications. Canadians now have a novel treatment available to help them maintain optimal blood glucose levels. Health Canada has approved Victoza (liraglutide), the first GLP-1 analogue, for once-daily administration for the treatment of adults with type 2 diabetes to improve glycemic control in combination with metformin or metformin and a sulfonylurea.

27 May 2010

FDA assigns BYDUREON new PDUFA action date of October 22, 2010

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. today announced that the U.S. Food and Drug Administration (FDA) has classified the BYDUREON™ (exenatide for extended-release injectable suspension) complete response as a Class 2 resubmission and assigned a new Prescription Drug User Fee Act (PDUFA) action date of October 22, 2010.

6 May 2010

Takeda settles with six defendants in generic ACTOS, ACTOplus met patent infringement lawsuit

Takeda Pharmaceutical Company Limited announced today that Takeda and its wholly owned subsidiary, Takeda Pharmaceuticals North America, Inc., have completed settlement agreements with six out of eight defendants in patent infringement litigation brought against these parties in response to their Abbreviated New Drug Applications for generic ACTOS® (pioglitazone HCl) and ACTOplus met® (pioglitazone HCl and metformin HCl). Takeda recently concluded litigation with the sixth settling defendant.

28 Apr 2010

Victoza produces greater reductions in A1C, FPG and body weight than Januvia: Study

Yesterday, The Lancet published online the results of the first study comparing the once-daily human GLP-1 analog, Victoza (liraglutide [rDNA] injection) with a DPP-4 inhibitor, Januvia. The 26-week trial showed that Victoza produced significantly greater reductions in A1C, fasting plasma glucose, and body weight than Januvia, with similar or better overall treatment satisfaction.

24 Apr 2010

Diabetic Ketoacidosis News and Research

Further Reading

Amylin, Lilly submit BYETTA sNDA for type 2 diabetes

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

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

FDA issues complete response letter for BYDUREON NDA

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

Type 1 diabetes, early recognition, telltale signs

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

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

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

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

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

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

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

Data shows Victoza produces greater reductions in A1c, body weight and FPG than Januvia

Data on BYETTA and SYMLIN injections, BYDUREON drug candidate to be presented at ADA 2010

DURATION-4 study tests superiority of BYDUREON as compared to other type 2 diabetes medications

Health Canada approves Victoza for treatment of adults with type 2 diabetes

FDA assigns BYDUREON new PDUFA action date of October 22, 2010

Takeda settles with six defendants in generic ACTOS, ACTOplus met patent infringement lawsuit

Victoza produces greater reductions in A1C, FPG and body weight than Januvia: Study

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