Sang-Man Jin1, Jae Hyeon Kim1, Kyung Wan Min2, Ji Hyun Lee3, Kue Jeong Ahn4, Jeong Hyun Park5, Hak Chul Jang6, Seok Won Park7, Kwan Woo Lee8, Kyu Chang Won9, Young-Il Kim10, Choon Hee Chung11, Tae Sun Park12, Jee-Hyun Lee13, Moon-Kyu Lee1. 1. Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea. 2. Diabetes Center, Eulji General Hospital, Eulji University School of Medicine, Seoul, South Korea. 3. Catholic University of Daegu. 4. Kyung Hee University School of Medicine, Seoul, South Korea. 5. College of Medicine, Paik Institute for Clinical Research, Inje University, Busan, South Korea. 6. Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, South Korea. 7. CHA Bundang Medical Center, CHA University School of Medicine, Seongnam, South Korea. 8. Ajou University School of Medicine, Suwon, South Korea. 9. Yeungnam University College of Medicine, Daegu, South Korea. 10. Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, South Korea. 11. Wonju College of Medicine, Yonsei University, Wonju, South Korea. 12. Chonbuk National University Medical School, Jeonju, South Korea. 13. Departments of Internal Medicine, Sanofi-Aventis Korea Co. Ltd, Seoul, South Korea.
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 andHbA1c 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.
RCT Entities:
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 insulinglargine were randomized to a basal-prandial group (stepwise addition of insulinglulisine) 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.
Authors: Sun Joon Moon; Hun Jee Choe; Soo Heon Kwak; Hye Seung Jung; Kyong Soo Park; Young Min Cho Journal: Diabetes Metab J Date: 2021-10-20 Impact factor: 5.893
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