Clinical outcomes in real-world patients with type 2 diabetes switching from first- to second-generation basal insulin analogues: Comparative effectiveness of insulin glargine 300 units/mL and insulin degludec in the DELIVER D plus cohort study

被引:62
作者
Sullivan, Sean D. [1 ]
Bailey, Timothy S. [2 ]
Roussel, Ronan [3 ,4 ,5 ]
Zhou, Fang Liz [6 ]
Bosnyak, Zsolt [7 ]
Preblick, Ronald [6 ]
Westerbacka, Jukka [7 ]
Gupta, Rishab A. [8 ]
Blonde, Lawrence [9 ]
机构
[1] Univ Washington, Sch Pharm, Seattle, WA 98195 USA
[2] AMCR Inst, Escondido, CA USA
[3] Ctr Rech Cordeliers, INSERM, U1138, Paris, France
[4] Univ Paris Diderot, Sorbonne Paris Cite, Paris, France
[5] Hop Bichat Claude Bernard, AP HP, DHU, FIRE,Diabetol Endocrinol & Nutr Dept, Paris, France
[6] Sanofi, 55 Corp Dr, Bridgewater, NJ 08807 USA
[7] Sanofi, Paris, France
[8] Accenture, Florham Pk, NJ USA
[9] Ochsner Med Ctr, Endocrinol Dept, Frank Riddick Diabet Inst, New Orleans, LA USA
关键词
basal insulin; glycaemic control; hypoglycaemia; observational study; type; 2; diabetes; 100; U/ML; GLUCOSE CONTROL; PROPENSITY SCORE; GLYCEMIC CONTROL; HYPOGLYCEMIA; PEOPLE; METAANALYSIS; 1-YEAR; TREAT; DRUGS;
D O I
10.1111/dom.13345
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Aims: To compare clinical outcomes in patients with type 2 diabetes (T2D) switching from insulin glargine 100 units/mL (Gla-100) or insulin detemir (IDet) to insulin glargine 300 units/mL (Gla-300) or insulin degludec (IDeg). Materials and Methods: We conducted a retrospective, observational study of electronic medical records for Gla-300/IDeg adult switchers (March 1, 2015 to January 31, 2017) with active records for 12-month baseline (glycated haemoglobin [HbA1c] used a 6-month baseline period) and 6-month follow-up periods. Gla-300 and IDeg switchers were propensity score-matched using baseline demographic and clinical characteristics. Outcomes were HbA1c change and goal attainment (among patients with HbA1c captured at follow-up), and hypoglycaemia with fixed follow-up (intention-to-treat [ITT]; 6 months) and variable follow-up (on-treatment [OT]; to discontinuation or 6 months). Results: Each matched cohort comprised 1592 patients. The mean decrease in HbA1c and HbA1c goal (<7.0% [53 mmol/mol] and <8.0% [64 mmol/mol]) attainment rates were similar for Gla-300 (n = 742) and IDeg (n = 727) switchers. Using fixed follow-up (ITT method), hypoglycaemia incidence decreased significantly from baseline with Gla-300 (all hypoglycaemia: 15.6% to 12.7%; P = .006; hypoglycaemia associated with inpatient/emergency department [ED] encounter: 5.3% to 3.5%; P = .007), but not with IDeg. After adjusting for baseline hypoglycaemia, no significant differences in hypoglycaemia incidence and event rate were found at follow-up (ITT) for Gla-300 vs IDeg. Using variable follow-up (OT), hypoglycaemia incidence was similar in both groups, but Gla-300 switchers had a lower inpatient/ED hypoglycaemia event rate at follow-up (adjusted rate ratio 0.56; P = .016). Conclusions: In a real-world setting, switching from Gla-100 or IDet to Gla-300 or IDeg was associated with similar improvements in glycaemic control and hypoglycaemia in adult patients with T2D.
引用
收藏
页码:2148 / 2158
页数:11
相关论文
共 35 条
[1]  
[Anonymous], 2018, DIABETES CARE, V41, pS1, DOI [10.2337/dc18-SINT01, 10.2337/dc18-Sint01]
[2]   A Tutorial on Methods to Estimating Clinically and Policy-Meaningful Measures of Treatment Effects in Prospective Observational Studies: A Review [J].
Austin, Peter C. ;
Laupacis, Andreas .
INTERNATIONAL JOURNAL OF BIOSTATISTICS, 2011, 7 (01)
[3]   A Tutorial and Case Study in Propensity Score Analysis: An Application to Estimating the Effect of In-Hospital Smoking Cessation Counseling on Mortality [J].
Austin, Peter C. .
MULTIVARIATE BEHAVIORAL RESEARCH, 2011, 46 (01) :119-151
[4]   Morning administration of 0.4 U/kg/day insulin glargine 300 U/mL provides less fluctuating 24-hour pharmacodynamics and more even pharmacokinetic profiles compared with insulin degludec 100 U/mL in type 1 diabetes [J].
Bailey, T. S. ;
Pettus, J. ;
Roussel, R. ;
Schmider, W. ;
Maroccia, M. ;
Nassr, N. ;
Klein, O. ;
Bolli, G. B. ;
Dahmen, R. .
DIABETES & METABOLISM, 2018, 44 (01) :15-21
[5]  
Blonde L, 2017, WCIRDC
[6]   New insulin glargine 300 U/ml compared with glargine 100 U/ml in insulin-naive people with type 2 diabetes on oral glucose-lowering drugs: a randomized controlled trial (EDITION 3) [J].
Bolli, G. B. ;
Riddle, M. C. ;
Bergenstal, R. M. ;
Ziemen, M. ;
Sestakauskas, K. ;
Goyeau, H. ;
Home, P. D. .
DIABETES OBESITY & METABOLISM, 2015, 17 (04) :386-394
[7]   Insulin glargine 300 units/mL: A new basal insulin product for diabetes mellitus [J].
Clements, Jennifer N. ;
Bello, Larkin .
AMERICAN JOURNAL OF HEALTH-SYSTEM PHARMACY, 2016, 73 (06) :359-366
[8]   Hypoglycemia in patients with type 2 diabetes newly initiated on basal insulin in the US in a community setting: impact on treatment discontinuation and hospitalization [J].
Dalal, Mehul R. ;
Kazemi, Mahmood R. ;
Ye, Fen .
CURRENT MEDICAL RESEARCH AND OPINION, 2017, 33 (02) :209-214
[9]   CONSENSUS STATEMENT BY THE AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY ON THE COMPREHENSIVE TYPE 2 DIABETES MANAGEMENT ALGORITHM-2017 EXECUTIVE SUMMARY [J].
Garber, Alan J. ;
Abrahamson, Martin J. ;
Barzilay, Joshua I. ;
Blonde, Lawrence ;
Bloomgarden, Zachary T. ;
Bush, Michael A. ;
Dagogo-Jack, Samuel ;
DeFronzo, Ralph A. ;
Einhorn, Daniel ;
Fonseca, Vivian A. ;
Garber, Jeffrey R. ;
Garvey, W. Timothy ;
Grunberger, George ;
Handelsman, Yehuda ;
Hirsch, Irl B. ;
Jellinger, Paul S. ;
McGill, Janet B. ;
Mechanick, Jeffrey I. ;
Rosenblit, Paul D. ;
Umpierrez, Guillermo E. .
ENDOCRINE PRACTICE, 2017, 23 (02) :207-238
[10]   Insulin degludec, an ultra-longacting basal insulin, versus insulin glargine in basal-bolus treatment with mealtime insulin aspart in type 2 diabetes (BEGIN Basal-Bolus Type 2): a phase 3, randomised, open-label, treat-to-target non-inferiority trial [J].
Garber, Alan J. ;
King, Allen B. ;
Del Prato, Stefano ;
Sreenan, Seamus ;
Balci, Mustafa K. ;
Munoz-Torres, Manuel ;
Rosenstock, Julio ;
Endahl, Lars A. ;
Francisco, Ann Marie Ocampo ;
Hollander, Priscilla .
LANCET, 2012, 379 (9825) :1498-1507