Non-inferiority Study

[logindetails]

I had a letter yesterday asking me if I'd be prepared to put myself forward for a clinical trial, INSTRIDE 1 (or INSTRIDE 2 for type 2's) investigating whether a generic long acting insulin produced by Mylan is as effective as Lantus.

I don't know if there is any payment for participating in the trial but as it would require me to swap my current insulins (Tresiba & NovoRapid) for Mylan's insulin glargine or Lantus & insulin lispro for meals, for up to 66 weeks, I doubt I will be putting myself forward.

An interesting quote from the letter:

"If the investigational medication is approved, it could be a more affordable treatment option, becoming more widely available and benefiting more people worldwide."

I applaud that (if approved) it will make the treatment of diabetes more affordable to many people worldwide. However I wonder if in the UK it will have the effect of restricting diabetics to a cheap generic insulin rather than one that is more suitable for them as doctors come under pressure to reduce NHS costs?

 

[catherinecherub]

Ill bump your post up @logindetails to see if anyone has any views on this.

 

[phoenix]

I think it's great, particularly for countries and individuals in places like the US that can't afford the more modern Insulins. Doctors in the UK and I think in Germany are already under pressure to revert to NPH as the basal insulin of first choice in T2. It's much cheaper and there is quite a lot of evidence to suggest that overall results in terms of HbA1c may not be that different.

There is already a generic from Lily ready to come onto the market and it has apparently already been approved in Europe but is facing a legal challenge in the US. http://www.pmlive.com/pharma_news/lantus_faces_first_biosimilar_rival_in_europe_598324
I hadn't heard of Mylan but apparently they make a lot of generic medications (wiki has an article with the good, the bad and the perhaps ugly about the company)It will hopefully add to the competition