Diabetologie und Stoffwechsel 2015; 10 - P243
DOI: 10.1055/s-0035-1549749

The 2 week fasting blood glucose (FBG) level as a predictor of HbA1c treatment response (HbA1c-TR) to once weekly dulaglutide 1.5 mg in patients with type 2 diabetes (T2DM)

T Forst 1, S Gough 2, G Grunberger 3, V Pechtner 4, R Shaginian 5, H Wang 6, L Fernandez 7
  • 1Profil Mainz, Mainz, Germany
  • 2University of Oxford and Oxford University Hospitals NHS Trust, Oxford, United Kingdom
  • 3Grunberger Diabetes Institute, Bloomfield Hills, United States
  • 4Lilly Diabetes, Eli Lilly & Company, Neuilly-sur-Seine, France
  • 5Lilly Diabetes, Eli Lilly and Company, Houten, Netherlands
  • 6Eli Lilly and Company, Indianapolis, United States
  • 7Lilly Diabetes, Eli Lilly and Company, Indianapolis, United States

Introduction: We assessed whether FBG in patients with T2DM measured early in treatment with the once-weekly GLP-1 receptor agonist dulaglutide 1.5 mg predicts HbA1c-TR.

Methods: Post-hoc analyses were conducted for 2 randomized studies in patients assigned to dulaglutide 1.5 mg [AWARD-5 with metformin (N = 304) and AWARD-1 with metformin and pioglitazone). AWARD-5 baseline tertile values were used to categorize FBG at baseline and week 2: low (< 7.9 mmol/l); intermediate (≥7.9 – 10.3 mmol/l); high (≥10.3 mmol/l). AWARD-5 HbA1c-TR was assessed at week 12 and 26 by combined efficacy endpoint (CEE):HbA1c< 7.0% or reduction from baseline > 0.8%, > 1.1% or > 1.6% (if baseline HbA1c< 8.0%, ≥8.0%-< 9.0%, ≥9.0% respectively). The association between week 2 FBG and HbA1c-TR at week 26 was validated in AWARD-1.

Results: AWARD-5 mean baseline HbA1c was 8.1% and FBG was 9.8 mmol/l; 33%, 32% and 36% of patients had FBG categorized as low, intermediate, and high, respectively. After 2 weeks' treatment, mean FBG was 7.2 mmol/l; 68%, 21% and 11% of patients had FBG in low, intermediate, and high categories, respectively. At week 26, mean HbA1c was 6.9%. FBG at week 2 and achieving CEE at week 26 were strongly associated (p< 0.001). A higher percentage of patients with low FBG (83%) at week 2 met CEE at week 26 compared with patients with intermediate (61%;p< 0.001) and high FBG (34%;p< 0.001). Similar findings were seen using AWARD-1 data.

Conclusion: Probability of achieving HbA1c-TR at week 26 was greatest for patients with low-category FBG at week 2. Week 2 FBG may be an early and useful measurement for predicting HbA1c-TR to once-weekly dulaglutide.