American Diabetes Association's Scientific Sessions (Continued)
ADA 2012 showed us improvements in insulin coming from Eli Lilly, Novo Nordisk, and Halozyme. First, Eli Lilly showed data comparing its new basal insulin, LY2605541, to Sanofi's Lantus. Though both were similar in terms of fasting blood glucose and A1C, those using LY2605541 exhibited a lower rate of nocturnal hypoglycemia, lower glycemic variability within days, and had one pound of weight loss (in contrast to around half a pound of weight gain seen with Lantus). However, LY2605541 was associated with higher levels of triglycerides and certain liver enzymes — these will be important safety considerations as the insulin is tested in a much larger upcoming study. Also on the basal insulin front were a number of presentations on Tresiba (Novo Nordisk's degludec). We did not learn much beyond what we've already written about it, but we were encouraged to see more data to support the drug's flatter profile, long duration, and less nocturnal hypoglycemia. As a reminder, Novo Nordisk has already submitted the new insulin for FDA approval and expects to hear back on October 29, 2012.
On the fast-acting insulin side, Halozyme had a number of encouraging presentations. The company is attempting to produce faster-acting insulin by adding an enzyme (PH20) that would temporarily degrade connective tissue in the skin, allowing insulin to be absorbed more quickly. Halozyme is testing two approaches: (1) Combining PH20 with current insulins like Novolog, Humalog, and Apidra (a "co-formulation") or (2) An injection of PH20 prior to inserting an insulin pump infusion set ("pre-administration"). Both approaches have been shown to significantly speed the action of insulin. In a study of 117 people with type 1 diabetes on multiple daily injections, a PH20 co-formulation with Novolog or Humalog reduced post-meal blood glucose by 82% relative to Humalog use alone (a separate study in people with type 2 diabetes found a 21% benefit). Another study testing pre-administration of PH20 also showed encouraging results: those who took an injection of PH20 prior to inserting a pump infusion set had a one-hour post-meal blood glucose of 143 mg/dl, compared to 184 mg/dl when PH20 was not used. Thus far, there have not been any safety concerns with Halozyme's PH20. Further studies of both approaches are planned, and we certainly hope these early results are confirmed.
The Results of the ORIGIN Trial
Lastly, one of the most highly anticipated sessions at ADA 2012 discussed the results of the ORIGIN trial (Outcome Reduction With Initial Glargine Intervention). The study was initiated in 2003, sponsored by Sanofi, and included 12,537 participants with prediabetes or early-stage type 2 diabetes. ORIGIN was designed to clarify the long-standing question of whether intensive glycemic control (through use of insulin) and/or use of omega-3 fatty acid supplement could decrease the risk of cardiovascular disease. After entering the trial, participants were randomized to one of four groups: (1) use of Lantus (Sanofi's basal insulin); (2) use of an omega-3 fatty acid supplement; (3) use of both Lantus and an omega-3 fatty acid supplement; or (4) use of placebo. The four groups were then followed for an average of six years.
Overall, ORIGIN found that use of Lantus did not increase the risk for cardiovascular disease or cancer — reassuring news for patients, although the six-year follow-up period may have been too short to definitively detect any increased or decreased risk. Treatment with Lantus did, however, reduce the risk of progression from prediabetes to diabetes by 28% as compared to those who did not receive Lantus. As expected, treatment with Lantus did modestly increase weight and the risk for hypoglycemia. With regards to omega-3 fatty acid supplementation, no effect on cardiovascular disease was observed, although a significant benefit on triglyceride levels was detected. From doctors we've spoken to, the results of the results of the ORIGIN were mostly unsurprising, and many believe the trial will unlikely affect the ways diabetes and prediabetes are treated today. We will be interested to see whether any difference in risk for cardiovascular disease emerges in the ORIGIN follow-up study ORIGINALE, which will monitor trial participants for at least two more years — we hope to see an even longer follow-up after that.
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Well maybe not so much a furor as a controversy. The question, bluntly put, is whether or not a single HbA1c reading should be sufficient and adequate to diagnose diabetes — and whether the conditions under which the test was conducted should have any bearing on the diagnostic or non-diagnostic value of the test. The lede from