Efficacy and safety of biphasic insulin aspart 70/30 versus exenatide in subjects with type 2 @entity6 failing to achieve glycemic control with @entity2449 and a XXXX .

@entity4051 @entity1 @entity2749 @entity14184 @entity6 @entity1209 @entity1017 @entity6757 @entity4136 @entity413 @entity2449
OBJECTIVE: To compare safety and efficacy of biphasic insulin aspart 70/30 ( @entity14184 ) with exenatide in subjects with @entity6 ( @entity6 ) not achieving glycemic targets with @entity2449 and @entity4136 in a randomized, open-label, 24-week trial. RESEARCH DESIGN AND METHODS: Subjects (N = 372, @entity6 > 6 months, age > or = 18 and < or = 80 years, HbA1c > or = 8%, insulin naive not achieving glycaemic targets, receiving @entity2449 and @entity4136 ) were randomized 1: 1: 1 to receive either @entity14184 QD (12 U before supper); @entity14184 BID (12 U divided equally between pre-breakfast and pre-supper); or exenatide (5 microg BID for 4 weeks and 10 microg BID thereafter). Efficacy (HbA1c, fasting plasma @entity413 [FPG]) and safety (adverse events and @entity2749 ) were assessed. RESULTS: Glycemic control achieved with both @entity14184 BID and @entity14184 QD was superior to that with exenatide ( @entity14184 BID-exenatide: @entity4051 c difference -0.91% [95% CI: -1.23 to -0.59%] and @entity14184 QD-exenatide: difference: -0.67% [95% CI: -0.99 to -0.34%]). At the end of the study, more subjects achieved HbA1c < 7% and < or = 6.5% in the @entity14184 BID group than in the exenatide group (HbA1c < 7%: 37% vs. 20%, p = 0.0060; @entity4051 c < or = 6.5%: 25% vs. 8%, p = 0.0004, respectively). Combined @entity2749 (major, minor, symptoms only) were reported by 56%, 61%, and 29% of the subjects in the @entity14184 QD, @entity14184 BID, and exenatide groups, respectively. Weight gain was observed in the @entity14184 group ( @entity14184 QD: 2.85 kg, @entity14184 BID: 4.08 kg) and weight loss was observed in the exenatide group (-1.96 kg). @entity1209 was responsible for discontinuation of seven subjects in the exenatide group and one subject in the @entity14184 BID group. CONCLUSIONS: Significantly more @entity6 @entity1 (poorly controlled with combination @entity2449 / @entity4136 ) achieved glycemic goals when treated with @entity14184 than with exenatide. The high baseline HbA1c values (approximately 10.2%) and the long duration of @entity6 (approximately 9 years) suggests that some subjects may have been in an advanced stage of their @entity6 and may not have had sufficient beta-cell function for a @entity6757 mimetic to be effective. The insulin-treated groups had more minor hypoglycemic events and @entity1017 but less gastrointestinal side-effects. In summary, @entity14184 was more efficacious in helping @entity1 with high baseline HbA1c achieve glycemic goals. CLINICAL TRIAL REGISTRATION: www.clinicaltrials.gov, NCT00097877.
