First rule of proving the value of therapy is to have a fair "control group". In this particular study - the "control group" was TREATED with oral diabetes medications. If you're using a drug to "control" the situation - it is illogical to assume you have a control group. I'd settle for pseudo-control group for supporting the truth behind this research.
The other beef I have with this study is assuming the patient has diabetes. Was this a 1 time glucose check or was it a 3 month snapshot via HbA1c? For an explanation of why this matters - please watch the video. You'll also get a few though on the untimely and unnecessary death of Tim Russert.
Also - how did the physicians qualify the treatment for a participant? Was the patient was thoroughly evaluated (stimulated C-peptide, antibodies present, HbA1c, etc.)? If so - the choice of treatment would have a direct correlation to the outcome. If antibodies were present - it seems if you wanted to show a definite result of diabetes in 1 year - you would assign these patients to the oral med group. Although this is a legal violation of the Hippocratic Oath (prescribing a medication that would DO HARM) - I'm sure the payoff was worth it for Novo. After all - they are running that campaign to get all people in the whole wide worth on analogues.
My lay interpretation of this study is that 51% (possibly 92%) of the 381 patients were experiencing transient elevated glucose to begin with. This means that if they had remained "untreated" the approximate 4 to 7 days they spent on diabetes treatment would have produced the same outcome without treatment. The morning fasting blood glucose of 126 mg/dL is not a fair threshold to diagnose DIABETES.
Was there a true control group in this study? I.e.) no treatment whatsoever? I also wonder what the diagnosing HbA1c was - and what it was when the study ended.
This study without a control is nothing more than a RUSE to justify the new Novo Nordisk A/S campaign for analogue treatment for Type 2 - another diabetes marketing scheme. And by the way - the whole wide world needs to know this is NOT insulin. Eli Lilly, Novo Nordisk, and Sanofi-Aventis sells ANALOGUES. It is NOT just like human insulin. It is a confusing foreign protein that lowers blood glucose. Well get back to this - but when the body perceives glucose levels are too low - it attacks any endogenous insulin (first) because it knows how to create the homegrown insulin - it knows how to create the antibodies to destroy it.
When the body no longer has the ability to destroy what no longer exists (aka analogue-dependent diabetes) it begins to create resistance at the insulin receptor cells. This is why Type 2 diabetics start increasing their dose to override the resistance to the analogues. Please forgive my redundant reference - mo' analogue, mo' money, mo' problems (Tim Russert).
The hook, line and stinker of this fishy research is the fact that a patient starting insulin therapy is not likely to see his or her doctor for at least a month. It is likely he/she will continue on the analogue for 30 days before visiting their doctor. By that time - the body will have begun creating insulin antibodies or islet cell antibodies to assist in destroying any endogenous insulin production - therefore REQUIRING the analogue dose to increase. This foreign analogue will also create the insulin receptors to shut-down to prevent HYPOGLYCEMIA . Believe me when I tell you - HYPOGLYCEMIA is far more traumatic to the body than hyperglycemia. Remember - those who still have functioning beta cells have C-PEPTIDE TO PROTECT FROM COMPLICATIONS OF DIABETES.
It is a common phenomenon for many Type 2s to begin on a dose that gradually doubles and even TRIPES. This could be evidence that endogenous insulin production is overridden by analogue therapy. A stimulated C-peptide test could confirm this hypothesis. The bottom line here is: less endogenous insulin production means less C-peptide and more vulnerability to the complications of diabetes.
[On any given Sunday - a person who does not have diabetes can have a blood glucose of 50 mg/DL or 500 mg/dL. The reason they do not experience complications of diabetes is because their beta cells function! Analogues override and prevent the healthy function of beta cells.]
I never said Big Pharma was stupid - in fact they're just brilliant at marketing studies to sell their products. I just hope this one doesn't dupe medical professionals the same way the "Humulin" insulin campaign did in 1983.
Increasing diagnosis, increasing complications, and higher costs -- who's benefiting here?
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