Improved Postprandial Glycemic Control with Faster-Acting Insulin Aspart in Patients with Type 1 Diabetes Using Continuous Subcutaneous Insulin Infusion

Bruce W Bode, Joseph A Johnson, Liselotte Hyveled, Søren C Tamer, Marek Demissie, Bruce W Bode, Joseph A Johnson, Liselotte Hyveled, Søren C Tamer, Marek Demissie

Abstract

Background: Faster aspart is insulin aspart (IAsp) in a new formulation, which in continuous subcutaneous insulin infusion (CSII) in subjects with type 1 diabetes has shown a faster onset and offset of glucose-lowering effect than IAsp.

Methods: This double-blind, randomized, crossover active-controlled trial compared 2-h postprandial plasma glucose (PPG) response, following 2 weeks of CSII with faster aspart or IAsp. Primary endpoint: mean change in PPG 2 h after a standardized meal test (ΔPGav,0-2h). Subjects (n = 43) had masked continuous glucose monitoring (CGM) throughout.

Results: Faster aspart provided a statistically significantly greater glucose-lowering effect following the meal versus IAsp: ΔPGav,0-2h: 3.03 mmol/L versus 4.02 mmol/L (54.68 mg/dL vs. 72.52 mg/dL); estimated treatment difference (ETD) [95% CI]: -0.99 mmol/L [-1.95; -0.03] (-17.84 mg/dL [-35.21; -0.46]; P = 0.044). One hour postmeal, PG levels were -1.64 mmol/L (-29.47 mg/dL) lower with faster aspart versus IAsp (P = 0.006). Interstitial glucose (IG) profiles supported these findings; the largest differences were observed at breakfast: 9.08 versus 9.56 mmol/L (163.57 vs. 172.19 mg/dL; ETD [95% CI]: -0.48 mmol/L [-0.97; 0.01]; -8.62 mg/dL [-17.49; 0.24]; P = 0.057). Duration of low IG levels (≤3.9 mmol/L [70 mg/dL] per 24 h) was statistically significantly shorter for faster aspart versus IAsp (2.03 h vs. 2.45 h; ETD [95% CI]: -0.42 [-0.72; -0.11]; P = 0.008). No unexpected safety findings were observed.

Conclusions: CSII delivery of faster aspart had a greater glucose-lowering effect than IAsp after a meal test. CGM results recorded throughout all meals supported this finding, with less time spent with low IG levels.

Keywords: Continuous glucose monitoring; Continuous subcutaneous insulin infusion; Insulin pump; Meal test; Postprandial plasma glucose; Type 1 diabetes.

Conflict of interest statement

Author Disclosure Statement B.W.B. reports grants and personal fees from Abbott, AstraZeneca, BD, Biodel, Boehringer Ingelheim, Dexcom, GSK, Insulet, Janssen, JDRF, Lexicon, Lilly, MannKind, Medtronic, NIH, Novo Nordisk, Pfizer, Sanofi, and Valeritas and holds shares with Aseko. L.H., S.T., and M.D. are employees of and hold shares with Novo Nordisk. J.J. has no competing financial interests.

Figures

FIG. 1.
FIG. 1.
Mean baseline-adjusted (A) and actual (B) PG levels over time following infusion with faster aspart or IAsp. Error bars represent standard error of the mean; faster aspart, faster-acting insulin aspart; IAsp, insulin aspart; PG, plasma glucose.
FIG. 2.
FIG. 2.
IG profile characteristics: (A) Mean change (increment) in IG with faster aspart and IAsp at 1 and 2 h following a meal over 2 weeks of treatment; (B) Mean postprandial (0–4 h) and peak IG values over 2 weeks of treatment; (C) Duration of low IG levels per 24 h; (D) Duration of high IG levels per 24 h. *0–4 h. Error bars represent standard error of the mean. IG, interstitial glucose.
FIG. 2.
FIG. 2.
IG profile characteristics: (A) Mean change (increment) in IG with faster aspart and IAsp at 1 and 2 h following a meal over 2 weeks of treatment; (B) Mean postprandial (0–4 h) and peak IG values over 2 weeks of treatment; (C) Duration of low IG levels per 24 h; (D) Duration of high IG levels per 24 h. *0–4 h. Error bars represent standard error of the mean. IG, interstitial glucose.

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Source: PubMed

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