DELIVER D+ compared outcomes of patients with T2D switching from Gla-100/IDet to Gla-300 or IDeg. Results from 5 subgroups are reported (overall results in separate abstract).
Electronic medical records (Predictive Health Intelligence Environment database) (3/1/15-1/31/17) were analyzed. Patients had ≥1 A1C during 6month baseline. Gla-300 and IDeg switchers were propensity score matched on baseline characteristics. Endpoints included A1C change and goal attainment among those with ≥1 A1C test during 3-6-month follow-up, and hypoglycemia (hypo) among all matched patients (6-month fixed follow-up [intention-to-treat]), among the 5 subgroups (Table).
The numbers of subgroup patients were similar between the 2 cohorts. There were no significant differences in A1C reduction or goal attainment, or hypo incidence or event rate, between the 2 cohorts, overall or by subgroup. Patients with A1C≥8% had the best A1C reduction but worst goal attainment. Hypo was greatest among patients at high hypo risk and those with renal impairment.
In a real-world setting of adults with T2D, switching from Gla-100/IDet to Gla-300 or IDeg resulted in comparable improvements in glycemic and hyporelated outcomes in various subgroups, similar to the overall population.
Table. A1C and hypo outcomes, overall and by subgroups.
| Subgroups | Gla-300 vs IDeg | ||||
| A1C reduction (%) | A1C <7% (%) | A1C <8% (%) | Hypoglycemia incidence (%) | Hypoglycemia event rate (PPPY) | |
| Overall | na=1,469 | na=3,184 | |||
| 0.64 vs 0.58 (p=0.49) | 15.1 vs 16.1 (p=0.63) | 44.3 vs 44.4 (p=0.98) | 12.7 vs 12.7 (p=0.75b) | 0.45 vs 0.47 (p=0.62 b) | |
| Basal-bolus patients | na=736 | na=1,605 | |||
| 0.56 vs 0.51 (p=0.67) | 15.1 vs 16.2 (p=0.69) | 38.2 vs 43.1 (p=0.18) | 14.3 vs 13.1 (p=0.81b) | 0.50 vs 0.48 (p=0.92b) | |
| Moderate/severe renal impairmentc | na=451 | na=935 | |||
| 0.58 vs 0.64 (p=0.70) | 16.8 vs 18.7 (p=0.62) | 44.0 vs 52.5 (p=0.07) | 18.5 vs 21.1 (p=0.17b) | 0.67 vs 0.85 (p=0.14b) | |
| Uncontrolled A1C (≥8%) | na=1,039 | na=2,254 | |||
| 0.98 vs 0.87 (p=0.35) | 9.3 vs 8.0 (p=0.51) | 31.7 vs 30.3 (p=0.64) | 12.5 vs 12.8 (p=0.65b) | 0.44 vs 0.47 (p=0.45b) | |
| High hypo riskd | na=755 | na=1,550 | |||
| 0.56 vs 0.58 (p=0.88) | 15.6 vs 16.8 (p=0.69) | 44.3 vs 44.9 (p=0.88) | 18.2 vs 18.2 (p=0.54b) | 0.69 vs 0.58 (p=0.65b) | |
| Age ≥65 years | na=503 | na=1,061 | |||
| 0.54 vs 0.47 (p=0.56) | 17.1 vs 18.0 (p=0.82) | 49.2 vs 55.9 (p=0.15) | 14.6 vs 15.0 (p=0.70b) | 0.46 vs 0.60 (p=0.14b) | |
| Subgroups | Gla-300 vs IDeg | ||||
| A1C reduction (%) | A1C <7% (%) | A1C <8% (%) | Hypoglycemia incidence (%) | Hypoglycemia event rate (PPPY) | |
| Overall | na=1,469 | na=3,184 | |||
| 0.64 vs 0.58 (p=0.49) | 15.1 vs 16.1 (p=0.63) | 44.3 vs 44.4 (p=0.98) | 12.7 vs 12.7 (p=0.75b) | 0.45 vs 0.47 (p=0.62 b) | |
| Basal-bolus patients | na=736 | na=1,605 | |||
| 0.56 vs 0.51 (p=0.67) | 15.1 vs 16.2 (p=0.69) | 38.2 vs 43.1 (p=0.18) | 14.3 vs 13.1 (p=0.81b) | 0.50 vs 0.48 (p=0.92b) | |
| Moderate/severe renal impairmentc | na=451 | na=935 | |||
| 0.58 vs 0.64 (p=0.70) | 16.8 vs 18.7 (p=0.62) | 44.0 vs 52.5 (p=0.07) | 18.5 vs 21.1 (p=0.17b) | 0.67 vs 0.85 (p=0.14b) | |
| Uncontrolled A1C (≥8%) | na=1,039 | na=2,254 | |||
| 0.98 vs 0.87 (p=0.35) | 9.3 vs 8.0 (p=0.51) | 31.7 vs 30.3 (p=0.64) | 12.5 vs 12.8 (p=0.65b) | 0.44 vs 0.47 (p=0.45b) | |
| High hypo riskd | na=755 | na=1,550 | |||
| 0.56 vs 0.58 (p=0.88) | 15.6 vs 16.8 (p=0.69) | 44.3 vs 44.9 (p=0.88) | 18.2 vs 18.2 (p=0.54b) | 0.69 vs 0.58 (p=0.65b) | |
| Age ≥65 years | na=503 | na=1,061 | |||
| 0.54 vs 0.47 (p=0.56) | 17.1 vs 18.0 (p=0.82) | 49.2 vs 55.9 (p=0.15) | 14.6 vs 15.0 (p=0.70b) | 0.46 vs 0.60 (p=0.14b) | |
aN was the aggregate of Gla-300 and IDeg switchers.
bP values adjusted for baseline hypo.
ceGFR <60 mL/min/1.73 m2 or nephropathy (ICD-9/ICD-10).
dAt least one of: ≥1 severe hypoglycemic (inpatient/ED) episode within prior 12 months; moderate renal impairment (eGFR 30–59 mL/min/1.73 m2); exposure to insulin for >4 years; recent episode of hypo (ICD diagnosis and/or glucose ≤70 mg/dL within the previous 12 weeks).
ED, emergency department; eGFR, estimated glomerular filtration rate; Gla-300, insulin glargine 300 U/mL; A1C, hemoglobin A1c; hypo, hypoglycemia; ICD, International Classification of Diseases; IDeg, insulin degludec; PPPY, per person per year.
S.D. Sullivan: None. T.S. Bailey: Research Support; Self; Abbott. Consultant; Self; Abbott. Speaker's Bureau; Self; Abbott. Research Support; Self; Ambra BioScience, Ascensia Diabetes Care, Becton, Dickinson and Company. Consultant; Self; Becton, Dickinson and Company. Research Support; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Calibra Medical. Consultant; Self; Calibra Medical. Research Support; Self; Companion Medical, Dexcom, Inc., Glooko, Inc., GlySens Incorporated, Lexicon Pharmaceuticals, Inc., Eli Lilly and Company. Consultant; Self; Eli Lilly and Company. Speaker's Bureau; Self; Eli Lilly and Company. Research Support; Self; Medtronic MiniMed, Inc.. Consultant; Self; Medtronic MiniMed, Inc.. Speaker's Bureau; Self; Medtronic MiniMed, Inc.. Research Support; Self; Novo Nordisk Inc.. Consultant; Self; Novo Nordisk Inc.. Speaker's Bureau; Self; Novo Nordisk Inc.. Research Support; Self; Sanofi. Consultant; Self; Sanofi. Speaker's Bureau; Self; Sanofi. Research Support; Self; Senseonics. Consultant; Self; Intarcia Therapeutics, Inc.. Research Support; Self; Versartis, Inc., Xeris Pharmaceuticals, Inc., MannKind Corporation. R. Roussel: Advisory Panel; Self; AbbVie Inc., Abbott, Eli Lilly and Company, Sanofi, Novo Nordisk A/S, AstraZeneca. Speaker's Bureau; Self; Servier. Consultant; Self; Bayer AG. Advisory Panel; Self; Merck Sharp & Dohme Corp.. Research Support; Self; Amgen Inc., Sanofi, Novo Nordisk A/S, Danone Research. Stock/Shareholder; Self; Iriade. Advisory Panel; Self; Physiogenex S.A.S. F.L. Zhou: Employee; Self; Sanofi. Stock/Shareholder; Self; Sanofi. Employee; Spouse/Partner; Lexicon Pharmaceuticals, Inc.. Stock/Shareholder; Spouse/Partner; Lexicon Pharmaceuticals, Inc. Z. Bosnyak: Employee; Self; Sanofi. Stock/Shareholder; Self; Sanofi. R. Preblick: Employee; Self; Sanofi. J. Westerbacka: Employee; Self; Sanofi. Stock/Shareholder; Self; Sanofi. R. Gupta: Other Relationship; Self; Sanofi. L. Blonde: Other Relationship; Self; AstraZeneca. Speaker's Bureau; Self; AstraZeneca. Advisory Panel; Self; Intarcia Therapeutics, Inc.. Other Relationship; Self; Lexicon Pharmaceuticals, Inc.. Advisory Panel; Self; Janssen Pharmaceuticals, Inc.. Other Relationship; Self; Janssen Scientific Affairs, LLC.. Speaker's Bureau; Self; Janssen Pharmaceuticals, Inc.. Advisory Panel; Self; Merck & Co., Inc., Novo Nordisk Inc.. Speaker's Bureau; Self; Novo Nordisk Inc.. Other Relationship; Self; Novo Nordisk Inc., Sanofi. Advisory Panel; Self; Sanofi. Speaker's Bureau; Self; Sanofi US.
