Today, we bring you more from the American Diabetes Association's 73rd Scientific Sessions in Chicago, an update on the most interesting new drugs, and some stand-out research. (See also: yesterday's big wrap-up.)
Two New Insulins and a Needle
Sanofi announced late-stage studies on its new investigational U-300 insulin showing that it's as effective as their leading basal insulin on the market, Lantus, but with 21% fewer night-time low blood sugars.
At this point, the insulin hasn't been named and is simply being referred to internally as "U-300." But within medical circles, various nicknames are being tossed around like, "Son of Lantus" and "Next-Gen Lantus." None of those are official FDA labels, of course!
So is this insulin meant to supersede Lantus? Wouldn't the company be "cannibalizing" its own success? In an on-site meeting at ADA, Sanofi officials danced around this issue, only telling me that they'd like to "expand customer choices" and see U-300 "established as the gold standard in basal therapy for the next decade."
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The Sanofi researchers say full data from their studies should be released by year's end and the company hopes to launch this product sometime in 2014.
Lilly's also working to get into the basal insulin game with a new product under development currently called LY2605541 (market name TBD). Phase 2 data shows that type 1 patients using this insulin had better glycemic control along with reduced meal-time insulin needs compared to those on Sanofi's Lantus. That is one of about a dozen medications Lilly has in its D-pipeline at the moment, and is expected sometime in the coming two years or so -- a key for the Pharma giant to compete against leading basal insulin manufacturerers Sanofi and Novo.
On the product names: apparently the companies cannot just wax poetic. Rather, FDA determines the names of new products based on extensive searches to be sure there's no confusion with other drugs on the market. Here's a great piece on how drug names come to be.
BD announced the U.S. launch of its "Ultra-Fine Nano 4mm Pen Needles" with what's called "EasyFlow Technology." Basically, the design makes it easier for people to use by just pushing down on the pen needle. Clinical data released at the Scientific Sessions shows that 61% of PWDs using these needles reported needing less thumb-force to inject, while about half of patients reported needing less time to inject than when using traditional pen needles.
As noted yesterday, there's a lot of excitement about Janssen's Invokana, a new oral drug aimed at type 2's, at least initially. It's the first FDA-approved product in the new class of drugs known as SGLT-2 inhibitors that remove extra glucose through the urine by blocking re-absorption by the kidney. That means it allows you to slough off extra glucose by peeing it out. Invokana, a once-daily pill, is expected to become a "mega-blockbuster" (!)
Studies show that SGLT-2 inhibitors also have weight loss benefits and help bring down high blood pressure -- so that would lend itself to blockbuster potential for sure.
My good friend Dr. Richard Jackson of Joslin Diabetes Center says this class of drug has potential to help type 1's as well, evening out postprandial blood sugars. We walked over together and asked a Janssen researcher. He wasn't allowed to say much, since that would be off-label use at this point, but he gave us the high sign that they'll be doing studies on type 1's shortly.
Playing catchup, Lilly and Boehringer Ingelheim Pharmaceuticals announced Phase 3 research results on their jointly developed investigational SGLT-2 inhibitor called empagliflozin, showing that this med combined with other treatments reduced A1C levels in type 2 PWDs.
Sanofi also announced new data on its investigational once-daily glucagon-like peptide (GLP-1) receptor called Lixisenatide, which studies show reduced insulin needs for type 2s when combined with basal insulin. Company execs told us they've seen "encouraging feedback" among physicians and patients so far, but the regulatory process will likely be slow, because this is one of the first diabetes drugs submitted to FDA under the new, stringent requirements to show cardiovascular effects. In other words, there's a whole other body of evidence regarding heart health that Sanofi will have to explore before getting this drug approved.
Pregnancy & Diabetes
It's great to see more research devoted to this once-marginalized topic — although all three of the highlighted new studies focused on food and weight gain (boo!)
- One study showed that traditional thinking on diets for gestational diabetes may be off-base. Instead of a low-carb, high-fat diet as traditionally recommended, these women did better eating more carbs and less fat. And by better, they mean the women's babies had less insulin resistance and less tendency to be overweight.
- Another study — which seems like a no-brainer but apparently needed empirical testing — showed that if moms work harder to control their weight during pregnancy, their babies are at lower risk for developing obesity and diabetes later in life.
- And then there was a study looking at continuous glucose monitoring (CGM) in pregnant women with type 1 diabetes. Obviously, the aggressive glucose targets imposed on pregnant PWDs put them at increased risk for hypoglycemia, so using a CGM is extremely helpful! But the researchers also found ways to use CGM data to track fetal growth patterns associated with the mother's glucose swings during activities such as eating, sleeping or exercise. They even think using a closed-loop system on pregnant PWDs could help prevent hypoglycemia in newborns during the first few days after birth. Encouraging stuff.
- Conventional wisdom turned on its head? That's how the ADA was marketing a study showing that the notion of eating frequent small meals throughout the day as a weight-loss strategy may be wrong after all. Researchers found that patients who ate two sizable meals per day — just breakfast and lunch, no dinner — had a greater decrease in BMI (body mass index) than their counterparts munching on six smaller meals throughout the day. Six meals seems like a lot, no matter how you slice it... and don't we constantly see studies that contradict conventional wisdom (and each other) in the diabetes world? I'm just sayin'... Takeaway: skip dinner, lose weight?
- A symposia on dietary sweeteners looked at the health risks of these chemical substitutes, and also at efforts by local governments around the country to discourage consumption of sugary drinks and snacks — especially in schools. There is no magic bullet here, but this comes in the wake of a recent Wall Street Journal article citing 10 national experts on "What''s the One Dietary Change the Average American Should Make?" Some pretty sound advice there, IMHO.
- Does insulin resistance trigger unhealthy food cravings in your brain? A study looking at obese vs. lean teenagers seems to indicate so. In the obese teens, the "reward" centers of the brain involving habit and motivation were activated by pictures of high-caloric foods. The researchers conclude that insulin resistance may influence food cravings — but personally, I'm not convinced it isn't the other way around. If you are someone who habitually looks to carb and calorie-rich foods for comfort, naturally your "reward center" lights up when presented with those treats. Then you probably consume a lot of them, which perhaps contributes to insulin resistance. Either way, it's not easy to break those brain-triggered habits, we know.
Again, I thank my colleague Mike Hoskins for his contributions to this post.