Basal‐prandial versus premixed insulin in patients with type 2 diabetes requiring insulin intensification after basal insulin optimization: A 24‐week randomized non‐inferiority trial
Year: 2015
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: 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.
Source: Journal of Diabetes
Institutions: Samsung Medical Center, Sungkyunkwan University, Eulji University, Eulji Medical Center, Daegu Catholic University, Sanofi (South Korea), Kyung Hee University, Inje University, Inje University Busan Paik Hospital, Seoul National University Bundang Hospital, CHA University Bundang Medical Center, CHA University, Ajou University, Yeungnam University College, Yeungnam University, University of Ulsan, Ulsan University Hospital, Yonsei University, Jeonbuk National University Hospital, Jeonbuk National University
Language: English
Subfield: Endocrinology, Diabetes and Metabolism
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
Funder: Sanofi
OpenAlex ID: W1595923925