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2011 BioMedTracker Post-ADA Report

August 15, 2011

The American Diabetes Association 71st Scientific Sessions took place on June 24 – 28 in San Diego, California.

This year's ADA was particularly interesting for evaluating physician opinions on recently approved and upcoming drugs, along with new data on earlier stage candidates. There were several major events and announcements soon after the conference, which we discuss, as well.

We also reviewed a couple of interesting debates, which shed light on physician perspectives over the benefit:risk profiles of older versus newer medications and how physicians should view A1C targets, given concerns over aggressive treatment raised by the ACCORD trial.

Key highlights of the report are:

  • Safety issues revealed at the conference for dapagliflozin led to negative FDA adcom vote, though there is still some possibility for approval. If approved, safety warnings would impede uptake until issues resolved.
  • Physician discomfort and concerns over effects of SGLT2 inhibition will require substantial education, but enthusiasm expressed by some adcom members over weight loss indicates this may be overcome. MDs likely to experiment with usage to see trade-off between weight loss and nuisance of urinary infections.
  • US physicians do not see much advantage to Tradjenta's lack of dose adjustment in moderate renal impairment, though there are possible strategies to mitigate this. EU physicians more interested, since Januvia EU label does not recommended usage in this group. Potential combination with SGLT2 inhibitor BI 10773 could help in non-renal patients.
    • Statistically significant CV benefit in Tradjenta meta-analysis and trial versus sulfonylurea. Trends or significance also seen in meta-analyses of other DPP-IV inhibitors. Physicians hopeful, but not ready to draw conclusions pending outcomes trials for this class, which do not start to report until 2014.
  • Interim data from CV trial allowed alogliptin resubmission shortly after ADA. Combination with Actos could help differentiate, but will depend on how Actos bladder cancer issue plays out. Most physicians not yet overly concerned, but usage has decreased somewhat since FDA advisories released and is likely to drop further.
  • Bydureon reported reassuring QT study after conference, allowing resubmission. Patient acceptance of injection device likely to be split, but physicians uncertain about relative percentages.
  • Exenatide suspension appears slightly weaker than Bydureon, and concerns about degree of weight loss. If subpar, could offset convenience of monthly dosing.
  • GPR40 agonist TAK875 shows good efficacy and safety versus glimepiride. Data on GPR119 agonist PSN821 too inconsistent for confident assessment of glycemic and weight effects.
  • Glucagon antagonist MK-0893 had multiple safety issues leading to suspension. Possibly mechanistic related, clouding prospects for the class.
  • Interest over lower hypoglycemia with degludec, but some criticism of studies for exaggerating the effects.
  • Discouragement over path forward in obesity, with possible exception of peripherally acting drugs like GLP-1. Dual/triple agonist peptides for diabetes and obesity highlighted at award lecture, though most advanced candidate only in Phase I. Some concerns with possible counteracting actions of different hormones, though quite interesting preclinical data.

For the full report, please download the PDF version at the top of this page.

For our disclosures, please read the BioMedTracker Research Standards.

Indications Covered: Diabetes Mellitus, Type I
Diabetes Mellitus, Type II