Diabetes

Hemoglobin A1c levels below 6% are associated with a small but significant increased risk of mortality in elderly patients, according to a retrospective cohort study published online in Diabetes Care.

Roche recently recalled its Accu-Chek FlexLink Plus infusion sets globally because they may under-deliver insulin to patients.

Evidence supports metformin as a first-line agent to treat type 2 diabetes, according to a study in the March 14, 2011, online edition of the Annals of Internal Medicine.

The management of type 2 diabetes mellitus needs to change in response to the evolving evidence base now available. Research from the ADVANCE and the ACCORD trials was presented during the American Diabetes Association 58th annual advanced postgraduate course in New York City.

FDA released a safety communication to update prescribers and patients about the ongoing review of insulin glargine (Lantus) that was initiated in July 2009.

The American College of Physicians recently issued 3 recommendations for use of intensive insulin therapy for the management of glycemic control in hospitalized patients.

FDA has announced that the physician labeling and patient medication guide for rosiglitazone (Avandia, GlaxoSmithKline) have been changed to include information on cardiovascular risks (including death) of this agent.

FDA has sent MannKind Corp. a complete response letter regarding the company?s NDA for Afrezza Inhalation Powder for the treatment of adult patients with type 1 and type 2 diabetes for the control of hyperglycemia.

New combination: Saxagliptin and metformin extended release (Kombiglyze XR) was approved to improve glycemic control in adults with type 2 diabetes mellitus.

Antihypertensive therapy with an angiotensin receptor blocker is not associated with reductions in cardiovascular or all-cause mortality compared to non-ARB-based regimens in patients with type 2 diabetes, according to researchers at the Massachusetts College of Pharmacy and Health Sciences.

FDA has approved saxagliptin and metformin XR (Kombiglyze XR, AstraZeneca and Bristol-Myers Squibb) tablets for the treatment of type 2 diabetes in adults. Kombiglyze XR is the first and only once-a-day metformin XR plus DPP-4 inhibitor combination tablet offering strong glycaemic control across glycosylated hemoglobin levels, fasting plasma glucose and post-prandial glucose.

In a multinational, placebo-controlled, double-blind trial, the selective vitamin D receptor activator paricalcitol (Zemplar, Abbott Laboratories), at doses of 1 µg or 2 µg daily, reduced albuminuria in patients with type 2 diabetes, who were already being treated with renin-angiotensin-aldosterone system inhibitors.

Metformin, either alone or in combination with sulfonylurea, appears to increase 1-year and long-term survival in patients with type 2 diabetes mellitus and chronic heart failure, according to research published in the October 1 issue of the American Journal of Cardiology, HealthDay News reported.

A systematic review assessing the comparative effectiveness of oral antidiabetic drugs for preventing patients at high risk from progressing to type 2 diabetes has found glitazones, biguanides, and alpha-glucosidase inhibitors reduced the relative risk of diabetes by as much as 63%, whereas insulin secretagogues had no effect.

New molecular entity: Saxagliptin (Onglyza), a DPP-4 inhibitor, was approved on July 31, 2009, for the treatment of type 2 diabetes mellitus

Initiation of antipsychotic therapy associated with hyperglycemia in older diabetic patients

Liraglutide is a glucagon-like peptide-1 (GLP-1) analogue that is currently pending FDA approval for the treatment of type 2 diabetes. This agent mimics the actions of food-induced endogenous GLP-1 release, thus causing glucose-dependent increased insulin secretion, decreased glucagon secretion, and reduced appetite and gastric emptying.

Labeling updates and warnings through April 2009 for insulin pens and cartridges

Compared with biguanides, thiazolidinediones, meglitinides, and second-generation sulfonylureas, metformin is the sole oral therapy associated with a decreased risk of cardiovascular (CV) mortality in patients with type 2 diabetes, according to a meta-analysis published in the Archives of Internal Medicine.

In a survey of trends in diabetes treatment from 1994 to 2007, investigators observed an increasing incidence of diabetes, a greater variety of drugs and combinations available for treatment, and a marked increase in the annual cost of diabetes medications.

Alogliptin is a highly selective DPP-IV inhibitor under investigation for the treatment of type 2 diabetes. An NDA for alogliptin was submitted in January 2008, and a response from FDA is expected in the fourth quarter of this year.

Drug Watch: Agents in late-stage development for the treatment of types 1 and 2 diabetes mellitus (September 2008)

A recent multinational, randomized, double-blind, placebo-controlled clinical trial demonstrated that administration of aliskiren provides additional renal protection to patients with hypertension, type 2 diabetes mellitus, and nephropathy who are already receiving optimal antihypertensive therapy and renal protective therapy with the angiotensin receptor blocker (ARB) losartan.

Among the new data presented at the 68th Scientific Sessions of the ADA were the results of phase 3 trials of the investigational agents liraglutide, ABT-335, saxagliptin, and alogliptin.

Drug Watch: Agents in late-stage development for the treatment of type 2 diabetes mellitus (August 2008)