Poster Presentation The Annual Scientific Meeting of the Australian Diabetes Society and the Australian Diabetes Educators Association 2013

Response to dapagliflozin by baseline HbA1c in head-to-head comparisons (#369)

Robert Henry 1 , Alexander V Murray 2 , Michael A Nauck 3 , Katja Rohwedder 4 , Eva Johnsson 5 , Shamik J Parikh 5 , Agata Ptaszynska 6
  1. University of California San Diego, VA San Diego Healthcare System, San Diego, California, USA
  2. PharmQuest, Greensboro, North Carolina, USA
  3. Diabetes Centre, Bad Lauterberg, Germany
  4. AstraZeneca, Wedel, Germany
  5. AstraZeneca, Wilmington, Delaware, USA
  6. Bristol-Myers Squibb, Princeton, New Jersey, USA

Dapagliflozin (DAPA), a selective SGLT2 inhibitor, reduces hyperglycaemia by removing excess blood glucose via the urine. The objective of this analysis was to directly compare the glycaemic efficacy of DAPA with other oral antidiabetic drugs (OADs) across a wide range of baseline HbA1c. DAPA was compared with other OADs in 2 randomised, double-blind clinical trials: Study 1 (NCT00660907), a 52-week trial of DAPA (≤10 mg) vs glipizide (GLIP, ≤20 mg) as add-on to metformin (MET); Study 2 (NCT00859898), a 24-week trial of DAPA 10 mg vs MET extended release 2000 mg as monotherapies. Mean baseline HbA1c was 7.7% (Study 1) and 9.1% (Study 2). Non-inferiority of DAPA to comparators for changes in HbA1c (primary endpoint) was previously described. Here we present analyses by baseline HbA1c levels (Figure). Both DAPA and comparators provided greater reductions in HbA1c in the higher baseline HbA1c subgroups. Furthermore, within each study, reductions by DAPA and comparator were similar for each baseline HbA1c category. In both studies, DAPA had a low intrinsic propensity for hypoglycaemia (Study 1: DAPA 3.5% vs GLIP 40.8%; Study 2: DAPA 0.9% vs MET 2.9%), consistent with the insulin-independent mechanism of action. In summary, as with the overall populations, DAPA demonstrated glycaemic responses similar to other OADs in subgroups stratified by baseline glycaemic control, producing larger reductions in HbA1c for individuals starting with higher baseline levels.