Initiating or switching to biphasic insulin aspart 30/70 therapy in subjects with XXXX . An observational study.

@entity1 @entity2175 @entity4051 @entity14184 @entity6 @entity4053
OBJECTIVE: To investigate tolerability and glycemic control over 26 weeks in @entity1 with @entity2175 ( @entity2175 ) who initiated insulin with, or switched to, biphasic insulin aspart 30/70 ( @entity14184 ) in routine clinical care. METHODS: This was a non-randomized, non-interventional, open-label, observational study involving @entity1 under the care of approximately 150 insulin-prescribing physicians in Denmark. All @entity1 enrolled were prescribed @entity14184 in routine care. Starting dose, dose titration and injection frequency were determined individually by each physician. Information on serious adverse drug reactions (SADR), glycemic parameters and hypoglycemic events were obtained from @entity1 ' notes, @entity1 ' diaries and recall, and transferred to case report forms by physicians at baseline (during 4 weeks prior to @entity14184 therapy) and after 12 and 26 weeks of treatment. RESULTS: 421 subjects were recruited and 392 provided safety data. The age (mean +/- SD) was 62.0 +/- 11.4 years, body mass index (BMI) 30.4 +/- 6.4 kg/m(2), duration of @entity6 9.1 +/- 8.1 years and HbA1c (%) 9.4 +/- 1.7. 199 subjects were prior insulin users and 193 were insulin-na  ve @entity1 . Four @entity1 reported a SADR (3 @entity4053 , 1 severe @entity4053 ). HbA1c was significantly reduced after 26 weeks of @entity14184 therapy: prior insulin users -1.2%, insulin-na  ve @entity1 -2.2% (both p < 0.001). 28% and 41% of @entity1 , respectively, reached target @entity4051 c < 7%. Overall the @entity4053 rate was lower for insulin-na  ve @entity1 than for prior insulin users: 5.0 vs. 6.6 episodes/ @entity1 -year (p < 0.05). CONCLUSION: Initiating insulin with, or switching insulin to, @entity14184 in routine care was safe and effective in @entity1 with @entity2175 .
