The results are based on post hoc analyses of 2 double-blinded, randomized phase III studies, AWARD-1 and AWARD-5. The AWARD-1 study compared the safety and efficacy of placebo, dulaglutide and exenatide in patients with type 2 diabetes on metformin and pioglitazone. The AWARD-5 study compared the safety and efficacy of placebo, dulaglutide and sitagliptin in patients with type 2 diabetes on metformin.
The primary outcome measure was reduction of HbA1c from baseline to 26 weeks (AWARD-1) or 52 weeks (AWARD-5). Both doses of dulaglutide examined in these studies (0.75 mg and 1.5 mg) significantly reduced HbA1c compared to the respective comparison drugs.
In AWARD-5, 3 categories of fasting blood glucose levels defined at baseline: low (less than 142 mg/dL), intermediate (between 142 and 185 mg/dL) and high (more than 185 mg/dL). At baseline, mean fasting blood glucose was 176 mg/dL. Patients were roughly evenly distributed in each group; 33% (n = 99) were in the low group, 32% (n = 97) in the intermediate group, and 36% (n = 108) in the high group. After two weeks of treatment with 1.5 mg dulaglutide, mean fasting blood glucose was 129 mg/dL and an increased number of patients were in the low group: 68% (n = 208) in the low group, 21% (n = 64) in the intermediate group, and 11% (n = 32) in the high group.
At baseline, the mean HbA1c was 8.1% (n = 304). At week 26 of the study, mean HbA1c was 6.9%. Fasting blood glucose at week 2 was strongly associated with achieving an HbA1c of <7.0% at week 26. A greater number of patients in the low category at week 2 achieved an A1c of <7.0% at week 26. The AWARD-1 data analysis produced similar results.
George Grunberger, MD, of the Grunberger Diabetes Institute, in Bloomfield Hills, Michigan, who published the findings added that, "We found out in the two studies that one could predict the eventual glycemic improvement by dulaglutide already after examining fall in fasting plasma glucose levels after 2 weeks." "If confirmed in other studies, clinicians could predict responders early on and perhaps decide whether to continue dulaglutide therapy or look for another modality much sooner than 8-10 weeks."
- Dulaglutide has shown that fasting blood glucose levels 2 weeks after beginning treatment are predictive of long-term glucose control
- The eventual glycemic improvement by dulaglutide could be predicted after examining fall in fasting plasma glucose levels after 2 weeks.
- This is preliminary information and needs to be studied further.
The findings were presented at the American Association of Clinical Endocrinologists annual meeting held from May 14th to 18th in Las Vegas, Nevada.