Efficacy and safety of biphasic insulin aspart 70/30 in type 2 diabetes patients of different race or ethnicity (INITIATEplus trial)

Bruce S. Trippe, Mark D. Shepherd, Franklin C. Coulter, Anuj Bhargava, Jason Brett, Pei Ling Chu, David S. Oyer

Research output: Contribution to journalArticlepeer-review

3 Scopus citations


Objective: To determine if self-titration using biphasic insulin aspart 70/30 (BIAsp 30) had a different impact on efficacy and safety across different racial/ethnic subgroups. Research design/methods: This was an exploratory, post hoc analysis by race (White vs. Black/African-American) and ethnicity (Hispanic/Latino vs. non-Hispanic/Latino) of data from the INITIATEplus trial. Participants were treated twice-daily with BIAsp 30 over 24 weeks. Trial registration: NCT00101751. Main outcome measures: Efficacy endpoints included reductions in mean glycated hemoglobin (A1C) and fasting plasma glucose (FPG). Safety endpoints included hypoglycemia rates (events/patient-year) and adverse events. Body weight changes were also measured. Results: Glycemic control improved by a similar extent for all demographic groups. Observed mean decreases in A1C ranged from 2.4 to 2.6 after 24 weeks' treatment. Baseline-adjusted mean A1C decreases for White vs. Black/African-American subjects were 2.56 and 2.13 (p<0.0001), and for Hispanic/Latino vs. non-Hispanic/Latino subjects were 2.45 and 2.42 (p=0.677), respectively. Final FPG values were similar among all groups (141146mg/dL [7.838.10mmol/L]), and baseline-adjusted FPG decreases were not significantly different (p>0.025) between groups. Hypoglycemia was low for White, Black/African-American, Hispanic/Latino, and non-Hispanic/Latino subjects (0.08, 0.04, 0.03, and 0.07 major events/patient-year, with 0.60, 0.30, 0.37, and 0.52 minor events/patient-year, respectively). Body weight increases were 3.17 and 3.06kg (White vs. African-American) and 2.69 and 3.19kg (Hispanic/Latino vs. non-Hispanic/Latino). Final weight-adjusted total daily insulin doses were 0.60U/kg for Black/African-American subjects vs. 0.78U/kg for White subjects (p<0.0001), and 0.71U/kg for Hispanic/Latino subjects vs. 0.74U/kg for non-Hispanic/Latino subjects (p=0.42). Limitations: The trial was not designed or powered for comparisons across racial or ethnic groups, subjects were not stratified for pre-baseline medication regimens between each race and ethnic group, and unequal subject numbers and baseline A1C disparities existed between the pairs of groups being compared. Conclusions: Diabetes self-management with BIAsp 30 using an easily followed self-titration algorithm produced low hypoglycemia rates. All subgroups achieved A1C reductions >2.1 and FPG declines >82mg/dL that were similar across groups, demonstrating that self-titration of BIAsp 30 can successfully be pursued in a primary care setting by patients who had previously failed to meet ADA A1C targets under oral antidiabetes therapy, with race or ethnicity not an obstacle to achieving better glycemic control.

Original languageEnglish
Pages (from-to)1203-1211
Number of pages9
JournalCurrent Medical Research and Opinion
Issue number7
StatePublished - Jul 2012
Externally publishedYes


  • BIAsp 30
  • Biphasic insulin aspart 70/30
  • Ethnicity
  • Glucose control
  • INITIATEplus
  • NovoLog Mix 70/30
  • Race
  • Self-titration
  • Type 2 diabetes


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