There is still no evidence to declare superiority of rapid-acting insulin analogues in the treatment of type 1 diabetes. These studies compared either insulin aspart (NovoLog) or insulin lispro (Humalog) with human insulin; no such study was available for glulisine (Apidra).

Based on average HbA1c values, patients treated with NovoLog had lower levels. However, statistical comparisons were so small that an effect on patients' health is not to be expected. It was also hypothesized that Humalog may prevent night time lows better than Apidra.

Even though patients have been treated with insulin analogues for 10 years, it is still unclear as to how these types of insulin affect long-term complications of type 1 diabetes. The long-term effects of insulin decisively increase the risk of heart disease and cancer, according to recent studies at Howard Hughs Medical Institute. Would you be surprised to learn that one of the insulin analogue manufacturers chose to withhold some of the results of their studies?

Story time!! Today is Bastille Day. The French National holiday commemorates the storming of the Bastille, which was a mark of the French Revolution - a revolt against absolute power.

Although I am not French - I am convinced there needs to be a revolution against absolute power of the insulin cartel. You all know them very well - Lilly, Novo and Sanofi Aventis. You've been a loyal customer, in spite of the shortcomings of their products. One example of a shortcoming is the absence of C-peptide. It is found in proinsulin and protects cells from the complications resulting from long-term diabetes. The other is the possibility that another source of insulin might be better for your treatment than synthetic human insulin. The fact the US only offers genetically modified human insulin is not fair when it comes to balance of power. Does this sound like a revolution that a feisty diabetic like me is starting?

I am not here to tickle a revolution. I'm determined to achieve it. Every diabetic deserves the right to choose their insulin. This choice should not be made for you by those who profit from the sale. I'm a type 1. I am a diabetic because my body made antibodies for human insulin. Why must I use insulin that continues creating these antibodies? I'd like to use something a little different that makes antibodies for horse or cow or PIG insulin. Can I get some pork up in here, please? It's difficult to obtain. It's as difficult as Ricky Bobby trying to say something in French. This Bastille Day Blog is a proclamation. As a prisoner of the insulin cartel - I declare that there will be a choice one day soon. Given the choice - you might opt for an insulin revolution, too. Laissez-faire!

Eli Lilly has an award they give to people who have been diabetic for 25, 50 and 75 years. They call it the Lilly for Life Award. The award recognizes people who have been enslaved to the exorbitant expenses of diabetes management, in addition to the other schedules of daily life. Endearing isn't it? The award is a significant token of Lilly's appreciation for all you have endured and sacrificed.

Lilly awards people who have used insulin for 25 years with the monetary equivalent of what your diabetes management has cost. All your copays for each bottle of insulin, each box of syringes, each blood sugar testing strip, and your ability to adapt to the ever-changing technology of diabetes care (I swear, it says that in block letters) - Lilly awards you $42,500!! I told you I lived in the land of milk and honey. ACTUALLY - it's a medal and a consent form to have your face exploited in Big Pharma marketing. You should've bought the stock! The shareholders of LLY paid approximately $1.75 per share 25 years ago, when you were diagnosed. Today that share is worth approximately $56. Anybody know the math on that return? It's probably around 3,000%.

Let's go back to that statement ever-changing technology of diabetes care. Why must it be ever-changing? Doesn't that sound a lot like never-ending? We need not spend too much time on identifying how to treat this disease when we've got that down. What we need to do is spend more time and energy on preventing the disease from happening in the first place. That is what I consider achievement. Achieve that, Lilly! And by the way - I'll take 3,000% of my $42,500 while you're at it. Thanks.

Slow and steady wins this race -- and that is why Flamel Technologies took the more natural approach with basal insulin in developing Basulin. The results in a comparison study with Lantus showed patients, while on Basulin, experienced 50% less hypoglycemic events.

Basulin is a controlled release of human insulin, not an insulin analogue like Lantus. The goal with Basulin is to deliver human insulin in order to reduce the risk of potential immune response which can be created by artificial insulins. Lantus has been the preeminent leader since its introduction in 2000. However, Lantus is an insulin analog, meaning that its molecular structure has been changed slightly, to sustain this long-lasting effect. The long-term effects and safety of insulin analogues have not been established.

In a human study, patients formerly treated with Lantus were then changed to Basulin. On the day prior to replacement of Lantus with Basulin, 11 hypoglycemic events were experienced in the 30 patients receiving Lantus. Once these patients were switched to Basulin for the 14 day trials, an average of only 5.1 hypoglycemic events per day occurred. This result is very encouraging, because hypoglycemia is a severe and commonly observed event in T1DM patients. Here is the billion dollar question (In 2006 over 60% of $8.9 billion was spent on long-acting insulin) -- is this more natural Basulin more fat-loving (like real human insulin) in comparison to the insulin analogue Lantus?

Mad Money is a stock show on CNBC hosted by Jim Cramer - a well-known iron fist on Wall Street. He has a following of stock enthusiasts who regard his recommendations (buy or sell) as gospel. Why is he so good at what he does? He just wants to help you make money.

And to this end -- the reason I bring Cramer's passionate drive to The Diabetes Blog is simple: last week he called Novo Nordisk as a SELL. Cramer said he's beginning to worry about a backlash on drug stocks. He advised that viewers should not be greedy and should take gains in Novo Nordisk (NVO).

Perhaps the NY Times article raised some eyebrows at Big Pharma. It appears doctors are receiving handsome gifts and stipends for handing out samples of drugs that were not all that safe for most patients. The payments give physicians an incentive to prescribe the medicines at levels that might increase patients' risks of heart attacks or strokes. In light of this blood curdling synopsis Novo got a dishonorable mention. Novo Nordisk professes to operate their company in two parts: biopharmaceuticals and Diabetes Care. The Diabetes Care segment provides insulin analogues, human insulin and insulin-related products, and oral antidiabetic drugs.

The cross examination of the C-peptide disappearing act and mysterious insulin auto-antibodies appearing where they shouldn't is just getting started. Thanks for making them sweat, Cramer!

Like a student driver -- the function of proinsulin (c-peptide) is as critically important as driver's education. The research was done, but because the information highway was just picking up speed (at the time back in '88) dissemination of such research was difficult, at best. Never fear - I found a good study to start things rolling.

Proinsulin (c-peptide) is made along with insulin in a 1 to 1 ratio from the beta cells. After a dose of proinsulin was administered - it took 5 to 10 minutes longer to lower a patient's blood sugar in comparison to insulin, alone. The rise of blood sugar following the lowest point was much slower, as well. In lay terms this means that insulin, coupled with proinsulin (c-peptide), results in a more controlled reaction. Kind of like the teenager with his permit to drive and Dad riding shotgun. The permit gives the kid the right to drive the car, but Dad is telling the kid when to accelerate and when to slow down. Insulin and proinsulin are quite similar in nature except we're talking about a life threatening hormone without the parental guidance.

The antilipolytic effect of proinsulin (tapping fat cells for energy and ANTI means this is stopped) was significantly stronger in comparison to insulin alone. Human proinsulin has a stronger effect on prevention of fat burning for energy in the absence of insulin (ketoacidosis). This seems logical because if you metabolize the glucose in your blood for energy - you will have little (if any) residual glucose to store as fat. Type 2 diabetics have a plethora of c-peptide in their body upon diagnosis but their blood sugar is also high. Looks like insulin and proinsulin reduces the risk of ketoacidosis and regulates fat metabolism.

Why did they decide to manufacture human synthetic insulin without it again? A personal experience pumping piggy proinsulin for 2 days now and I've seen definite control in my blood sugar fluctuations - less than 20 mg/dL in any testing window. It feels like the newly introduced highly purified porcine proinsulin came with a built-in continuous glucose monitor (i.e., C-peptide). More to come...

A study published in 1991, comparing the efficacy of human synthetic insulin to porcine insulin states "there is no reason to treat all insulin-requiring diabetic subjects with human insulin except those who have developed insulin allergy".

In light of this study - how was rDNA synthetic human insulin able to monopolize the US market?

The absence of highly purified porcine insulin in the US is probably (my guess) because it's cheaper to manufacture. The saturation of the US market with rDNA synthetic human insulin seems to be treating the masses with a specialized need existing in only a few individuals. But the top line of this marketing campaign must have had a good effect on the bottom-line, too. Sales reps convinced doctors to switch their patients because it was going to become nearly impossible to continue getting animal derived insulin. The insurance companies (the guys picking up the tab) must've loved this option, too. Why wouldn't they? It's better - right?

I'm going to do a self-analysis of the stuff, based on my IAA, IA and C-peptide levels. I've been on human synthetic insulin since 1985. I've never been on highly purified porcine insulin. The IAA is my insulin autoantibodies -- the antibody attacking my islets. My IA is the insulin antibody attacking the injected insulin and my c-peptide will tell me how much insulin my body is making. After 12 weeks on the highly purified porcine insulin - I'm going to do my labs again. I'm curious to see if these levels move, at all. If my c-peptide levels rise, that's a GOOD indicator what's best for Allie Beatty.

So is the best choice for me the best choice for all? Probably not. But at least I can see for myself - even if it costs me a pretty penny to get my hands on highly purified porcine insulin. Nobody said being an experimentalist was cheap. However, never exploring my options would deeply discount the value of experience.

"A few times I've been around that track so it's not just gonna happen like that because I ain't no hollaback girl", like Gwen Stefani says in her motivational chant - I want answers.

This is not an attack in any way. This is an attempt to get answers as to why human synthetic insulin was manufactured without C-peptide. Yesterday Eli Lilly called me back. Admittedly, J Scott Macgregor told me he doesn't receive many questions about human synthetic insulin development. He asked me to email. No problem. My email said:

Why did Eli Lilly manufacture human synthetic insulin without c-peptide?

As Scott Strumello points out in his blog, I've tried to contact Eli Lilly before about this issue. And I guess it look a little while for the resonating curiosity of the blogosphere to provoke a response. Again - no problem. The content of my email is an open opportunity for every diabetic injecting insulin to ask away. I think we've got Eli Lilly's attention and we're on the right path to getting answers. Now where's that turn for C-peptide?

As a diabetic with the esteemed honor of pouring my heart and soul out for an audience as well-informed as you - I feel it is OUR job to inform our doctor's of the important discoveries being made in diabetes. The discovery I am most concerned with these days is raising awareness of C-peptide.

When I learned that all forms of synthetic human insulin these days DO NOT have C-peptide (like natural human insulin does) I asked my doctor what C-peptide does. My doctor explained, "C-peptide is nothing more than a biomarker to tell us [doctors] how much insulin your body is naturally producing."

When Chrissie in Belgium asked her doctor he told her that [C-peptide] has absolutely no importance. Uh oh...

Doctor's are convinced that C-peptide is useless for type 1 diabetics. Give the next paragraph consideration and you and your doctor might have a new perspective on the importance of C-peptide.

In a healthy, nondiabetic individual -- islets produce insulin. Insulin is made of 51 amino acids in 2 chains, with a tail of something called C-peptide (connecting peptide). Insulin grabs sugar from the blood and transports it into the cells where it becomes energy. It gets into and out of the cells through cellular pathways that are monitored by a delicate balance of sodium (Na) and potassium (K). This balance is regulated by C-peptide. The movement of insulin and glucose through these cellular membranes without C-peptide is dangerous and causes diabetic complications that develop in small vessesls of the eyes, kidneys and nerves.

Tight control of diabetes results in complications over time. If you find 500 mg of protein in a 24 hour urine collection - it's a complication (nephropathy). If your nerve conduction velocity reaction time is measured at 5.0 seconds - it's a complication (neuropathy). You take your insulin -- these complications should not occur, right? The reason for diabetic complications may not be your insulin at all. It may be the thing that your insulin is lacking.

So here's a little community service we ALL can do to enlighten our doctor's. Ask your doctor about C-peptide. Chances are you will get the same answer Chrissie in Belgium and I did. When this happens - smile, and politely hand your doctor a printout of this blog.

After all, if the Creator put receptors in our cellular membranes - He must've done it for a reason. The path to enlightenment is paved with gold.

Now that the US market is suspiciously saturated with human insulin - and many of us diagnosed within the last 10 years did not have a shot at trying porcine insulin - I'd like to set the record straight. When the pharmaceutical companies cherry pick the studies they wish to use for their gain, and not so much for your enhanced quality of life - they must've lost this study.

Please read the entire study (if you have access to it in a local library) but what grabbed my undivided attention was the sentence that says: it was observed that the action of porcine insulin was associated with... a striking increase of prolactinaemia, in relation to semisynthetic human insulin.

Okay -- so as I look deeper into the function of prolactin -- aside from some definite dopamine enhancing activities (if you know what I mean) :::wink wink::: -- it is responsible for the formation of myelin coatings on axons in the central nervous system. This is a certifiable problem that results in diabetic neuropathy and the related side effects (numbness, nerve dysfunction, i.e, ED).

Ex-queeze me? Does this say that human synthetic insulin may be a cock blocking drug?

Sorry for the blunt delivery -- but this is the truth. Why doesn't human synthetic insulin have this listed as a side effect? My guess is: if you had a choice of human synthetic insulin versus highly purified porcine insulin -- and you knew the side effects of human synthetic might take a toll on the health of your sex life -- you might be praying to the porcine gods.

Shame on the companies who knew about this study and kept it undercover so you couldn't...

While patrolling the PubMed database this weekend, I came across a very interesting study that investigated the effects of new insulins on insulin and C-peptide antibodies, insulin dose, and diabetic control. Please note - this study was published in 1983. After reading -- I invite EVERYONE to let me know if it is possible to get purified pork insulin and whether or not you have been on it-- and if you have seen a difference in your diabetes control. Please?

24 diabetic patients using bovine (beef) insulin and possessing insulin antibodies underwent a study of the immunological and clinical consequences of changes in both purity and species of their insulin. The new insulin regimes tested were one of three: a) purified bovine insulin, b) highly purified porcine insulin, and c) semisythetic human insulin.

The patients underwent 3 consecutive 4-month periods on each insulin regimen. The average insulin antibody levels changed little on purified bovine (beef) insulin; actually increased on semi-synthetic human insulin but fell substantially on highly purified porcine insulin. Okay - so this means, in lay terms that the patient's insulin antibodies (the stuff killing your islets) remained relatively the same on beef insulin but became categorically HIGH on synthetic human insulin. And most importantly - to me-the highly purified porcine insulin actually DROPPED the insulin antibodies. Of course - it would cost big pharmaceutical companies more to manufacture highly purified porcine insulin.

C-peptide antibodies fell significantly and continuously throughout the study. The slower rate of fall in C-peptide antibody levels is likely to be due to the prolonged half-life of circulating exogenous proinsulin in the presence of insulin antibody. Although insulin dose remained constant the incidence of hypoglycaemic episodes did not increase and glycosylated haemoglobin levels rose significantly when patients were on porcine insulin. The deterioration in diabetic control may have been due to greater temporal mismatch between insulin needs and insulin availability with pork or human insulin than with beef insulins, and to reduced insulin antibody levels.

The use of purer insulins which more closely resemble the human form can cause a significant reduction in levels of insulin and C-peptide antibodies. These changes may not necessarily produce better diabetic control. Recent studies have shown that a depletion of C-peptide in the body results in a greater chance of microvascular complications associated with diabetes.

This study was published around the time when all of the synthetic human insulins were sweeping the Nation. I tried calling my local CVS Pharmacy on Saturday morning to see if I could get some purified porcine insulin. No such luck. Go figure. The big guys were successful at convincing the medical community and patients that no other insulin is better. Correction - no other insulin is cheaper to manufacture and that means it is better for them. And the importance of C-peptide was overlooked entirely - or was it? C-peptide prevents the complications associated with injecting insulin - but that sounds like another marketable drug. After all - synthetic human insulin doesn't have C-peptide. REAL HUMAN INSULIN does (the way it comes out of the beta cells, in natural form, it does)!!! And as long as your body is producing insulin antibodies - you NEED their synthetic insulin (conveniently -- the only kind you can buy). Best business model - customer for life!

A brilliant doctor, a motivational mission, and the biggest names of the industry -- success is the only option. Taking Control Of Your Diabetes is a diabetic conference designed to educate and motivate people about diabetes.

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