Open AccessBasal‐prandial versus premixed insulin in patients with type 2 diabetes requiring insulin intensification after basal insulin optimization: A 24‐week randomized non‐inferiority trial
Author(s) -
Jin SangMan,
Kim Jae Hyeon,
Min Kyung Wan,
Lee Ji Hyun,
Ahn Kue Jeong,
Park Jeong Hyun,
Jang Hak Chul,
Park Seok Won,
Lee Kwan Woo,
Won Kyu Chang,
Kim YoungIl,
Chung Choon Hee,
Park Tae Sun,
Lee JeeHyun,
Lee MoonKyu
Publication year - 2016
Publication title -
journal of diabetes
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.949
H-Index - 43
eISSN - 1753-0407
pISSN - 1753-0393
DOI - 10.1111/1753-0407.12312
Subject(s) - medicine , insulin , hypoglycemia , insulin aspart , insulin glargine , endocrinology , diabetes mellitus , basal (medicine) , type 2 diabetes , randomized controlled trial
Background The aim of the present 24‐week multicentre randomized non‐inferiority trial was to compare the efficacy and safety of two insulin intensification strategies in uncontrolled type 2 diabetes despite optimized basal insulin therapy. Methods Patients with fasting plasma glucose ( FPG ) <130 mg/dL and HbA1c 7.0%–10.0% while on insulin glargine were randomized to a basal‐prandial group (stepwise addition of insulin glulisine) or a premixed insulin group (insulin aspart/insulin aspart protamine 30/70 starting with 6 IU twice daily). The primary endpoint was the change in HbA1c after 24 weeks (non‐inferiority margin 0.4%). Results At Week 24, the adjusted mean change from baseline HbA1c was –0.94 ± 0.09% and –1.04 ± 0.09% in basal‐prandial and premixed insulin groups, respectively, with a mean difference of –0.09% (95% confidence interval [ CI ] –0.35, 0.16). A lower rate of hypoglycemia with a similar reduction in HbA1c was observed during stabilization of the total daily insulin dose in the premixed insulin group (Weeks 0–12). After stabilization of the total daily insulin dose, the rate of hypoglycemia and the total daily insulin dose were similar in the two groups. Conclusions The efficacy and safety of the two intensifying regimens were similar after stabilization of the total daily insulin dose when oral agents were maintained. Starting with a lower total daily insulin dose with a gradual change in the treatment regimen was helpful in reducing the rate of hypoglycemia during initial stabilization of the total daily insulin dose.