In The News

Empagliflozin and Progression of Kidney Disease in Type 2 Diabetes

June 14, 2016. This study evaluated a prespecified secondary objective of the EMPA-REG OUTCOME study: long-term renal outcomes associated with the use of the sodium-glucose cotransporter-2 inhibitor empagliflozin in patients with type 2 diabetes at high risk for cardiovascular events. Patients were randomly assigned to receive empagliflozin 10 or 25 mg or placebo. Incident or worsening nephropathy and rates of renal replacement therapy were all significantly lower in the empagliflozin group.

FDA Releases a Drug Safety Communication With Strengthened Kidney Warnings for Canagliflozin and Dapagliflozin

June 14, 2016. The US Food and Drug Administration has strengthened an existing warning regarding the risk of acute kidney injury with use of the sodium-glucose cotransporter-2 inhibitor medicines canagliflozin and dapagliflozin for the treatment of type 2 diabetes. Specifically, the FDA has revised the warning section of the canagliflozin and dapagliflozin drug labels to include information about acute kidney injury and recommendations to minimize this risk.

Cardiovascular Mortality in Patients With Type 2 Diabetes and Recent Acute Coronary Syndrome

This study—Examination of Cardiovascular Outcomes with Alogliptin versus Standard of Care (EXAMINE)—evaluated the risk of cardiovascular (CV) death in all EXAMINE study participants compared with patients who experienced a major, nonfatal CV event during the EXAMINE study period. Patients with type 2 diabetes (N=5,380) who had experienced an acute coronary syndrome within the past 15 to 90 days were assigned to treatment with alogliptin or placebo. Outcomes evaluated included CV death and other nonfatal CV events.

The LEADER Study: Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes

This randomized, double-blind trial evaluated the cardiovascular (CV) effects of liraglutide versus placebo in patients with type 2 diabetes and high cardiovascular rish. The composite primary outcome of this time-to-event noninferiority trial included the first occurrence of death from CV causes, nonfatal myocardial infarction, or nonfatal stroke. A total of 9,340 patients were followed for a median of 3.8 years.

Once-Daily Delayed-Release Metformin Lowers Plasma Glucose and Has Similar Effect on Gut Hormones Compared With Immediate-Release Metformin

Two small, randomized controlled, crossover trials (one blinded, one not) were conducted to evaluate the gut-based action of a delayed-release (DR) formulation of metformin vs immediate-release (IR) metformin. Patients receiving metformin DR had an almost 60% reduction in systemic drug exposure compared with metformin IR. However, both treatments similarly decreased fasting and postprandial glucose, led to similar gut hormone responses, and had similar adverse event profiles.

FDA Approves Extended-Release Linagliptin/Metformin Combination

May 31, 2016. The US Food and Drug Administration has approved a once-daily, extended-release oral combination of the dipeptidyl peptidase-4 inhibitor linagliptin and metformin to treat adults with type 2 diabetes. The tablets combine 2.5 mg or 5.0 mg linagliptin with 1000 mg metformin. You can read the full article here.

Insulin Degludec/Liraglutide Combination Therapy Recommended by FDA Panel

May 24, 2016. A US Food and Drug Administration advisory committee unanimously recommended the approval of IDegLira, a combination of insulin degludec and liraglutide, for the treatment of type 2 diabetes. Although the formulation’s safety is not under question, concerns were raised regarding the clinical utility of IDegLira. Specifically, the methodology of clinical trials and insulin/liraglutide dosing methods were called into question. Advisers also noted that a clear target group for this formulation has not yet been identified.

Canagliflozin/Metformin Combo Approved as First Line for Diabetes

May 24, 2016. The US Food and Drug Administration has approved Invokamet, a fixed-dose combination of canagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, and metformin, for the first-line treatment of adults with type 2 diabetes.You can read the full article here.

FDA Drug Safety Communication: Interim Results Find Increased Risk of Leg/Foot Amputations With Canagliflozin

March 18, 2016. The US Food and Drug Administration (FDA) has issued a public alert regarding interim safety results for the sodium-glucose cotransporter 2 (SGLT2) inhibitor canagliflozin, obtained from an ongoing clinical trial of the drug. Specifically, an increased prevalence in leg and foot amputations has been observed, mostly affecting the toes, in patients treated with canagliflozin. The FDA is investigating this issue and will update the public when they have more information. You can read the full article here.

Diabetes Medications as Monotherapy or Metformin-Based Combination Therapy for Type 2 Diabetes

April 19, 2016. This systematic review and meta-analysis was conducted to evaluate the comparative effectiveness of various monotherapies and selected metformin-based combinations available to treat type 2 diabetes (T2D). The study evaluated thiazolidinediones, metformin, sulfonylureas, dipeptidyl peptidase-4 inhibitors, sodium-glucose cotransporter 2 inhibitors, and glucagon-like peptide-1 receptor agonists, along with selected metformin-based combinations. A total of 179 head-to-head studies and 25 observational studies were evaluated.