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Fast-acting insulin aspart versus insulin aspart in the setting of insulin degludec-treated type 1 diabetes: Efficacy and safety from a randomized double-blind trial.
Diabetes Obes Metab 2018; 20(12):2885-2893DO

Abstract

AIM

To evaluate the efficacy and safety of mealtime or post-meal fast-acting insulin aspart (faster aspart) vs mealtime insulin aspart (IAsp), both in combination with insulin degludec, in participants with type 1 diabetes (T1D).

METHODS

This multicentre, treat-to-target trial (Clinical trial registry: NCT02500706, ClinicalTrials.gov) randomized participants to double-blind mealtime faster aspart (n = 342) or IAsp (n = 342) or open-label post-meal faster aspart (n = 341). The primary endpoint was change from baseline in HbA1c 26 weeks post randomization. All available information, regardless of treatment discontinuation, was used for evaluation of the effect.

RESULTS

Non-inferiority for the change from baseline in HbA1c was confirmed for mealtime and post-meal faster aspart vs IAsp (estimated treatment difference [ETD]: 95%CI, -0.02% [-0.11; 0.07] and 0.10% [0.004; 0.19], respectively). Mealtime faster aspart was superior to IAsp for 1-hour PPG increment using a meal test (ETD, -0.90 mmol/L [-1.36; -0.45]; P < 0.001). Self-monitored 1-hour PPG increment favoured faster aspart at breakfast (ETD, -0.58 mmol/L [-0.99; -0.17]; P = 0.006) and across all meals (-0.48 mmol/L [-0.74; -0.21]; P < 0.001). Safety profiles and overall rate of severe or blood glucose-confirmed hypoglycaemia were similar between treatments, but significantly less hypoglycaemia was seen 3 to 4 hours after meals with mealtime faster aspart.

CONCLUSION

Mealtime and post-meal faster aspart in conjunction with insulin degludec provided effective glycaemic control compared with IAsp, with no increased safety risk. Mealtime faster aspart provided PPG control superior to that of IAsp.

Authors+Show Affiliations

Division of Endocrinology, Department of Medicine, University of North Carolina School of Medicine, North Carolina.International Diabetes Center, Minneapolis, Minnesota.Division of Diabetes, Endocrinology and Metabolism, Department of Internal Medicine, Shinshu University School of Medicine, Nagano, Japan.Diabetes Unit, Division of Internal Medicine, Hadassah Hebrew University Hospital, Jerusalem, Israel.Institute of Diabetes Research, Münster, Germany.Novo Nordisk A/S, Søborg, Denmark.Novo Nordisk A/S, Søborg, Denmark.Novo Nordisk Pharma Ltd, Tokyo, Japan.Department of Diabetes and Metabolic Diseases, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

30259644

Citation

Buse, John B., et al. "Fast-acting Insulin Aspart Versus Insulin Aspart in the Setting of Insulin Degludec-treated Type 1 Diabetes: Efficacy and Safety From a Randomized Double-blind Trial." Diabetes, Obesity & Metabolism, vol. 20, no. 12, 2018, pp. 2885-2893.
Buse JB, Carlson AL, Komatsu M, et al. Fast-acting insulin aspart versus insulin aspart in the setting of insulin degludec-treated type 1 diabetes: Efficacy and safety from a randomized double-blind trial. Diabetes Obes Metab. 2018;20(12):2885-2893.
Buse, J. B., Carlson, A. L., Komatsu, M., Mosenzon, O., Rose, L., Liang, B., ... Kadowaki, T. (2018). Fast-acting insulin aspart versus insulin aspart in the setting of insulin degludec-treated type 1 diabetes: Efficacy and safety from a randomized double-blind trial. Diabetes, Obesity & Metabolism, 20(12), pp. 2885-2893. doi:10.1111/dom.13545.
Buse JB, et al. Fast-acting Insulin Aspart Versus Insulin Aspart in the Setting of Insulin Degludec-treated Type 1 Diabetes: Efficacy and Safety From a Randomized Double-blind Trial. Diabetes Obes Metab. 2018;20(12):2885-2893. PubMed PMID: 30259644.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Fast-acting insulin aspart versus insulin aspart in the setting of insulin degludec-treated type 1 diabetes: Efficacy and safety from a randomized double-blind trial. AU - Buse,John B, AU - Carlson,Anders L, AU - Komatsu,Mitsuhisa, AU - Mosenzon,Ofri, AU - Rose,Ludger, AU - Liang,Bo, AU - Buchholtz,Kristine, AU - Horio,Hiroshi, AU - Kadowaki,Takashi, Y1 - 2018/10/10/ PY - 2018/07/16/received PY - 2018/09/11/revised PY - 2018/09/23/accepted PY - 2018/9/28/pubmed PY - 2018/9/28/medline PY - 2018/9/28/entrez KW - clinical trial KW - hypoglycaemia KW - insulin therapy KW - type 1 diabetes SP - 2885 EP - 2893 JF - Diabetes, obesity & metabolism JO - Diabetes Obes Metab VL - 20 IS - 12 N2 - AIM: To evaluate the efficacy and safety of mealtime or post-meal fast-acting insulin aspart (faster aspart) vs mealtime insulin aspart (IAsp), both in combination with insulin degludec, in participants with type 1 diabetes (T1D). METHODS: This multicentre, treat-to-target trial (Clinical trial registry: NCT02500706, ClinicalTrials.gov) randomized participants to double-blind mealtime faster aspart (n = 342) or IAsp (n = 342) or open-label post-meal faster aspart (n = 341). The primary endpoint was change from baseline in HbA1c 26 weeks post randomization. All available information, regardless of treatment discontinuation, was used for evaluation of the effect. RESULTS: Non-inferiority for the change from baseline in HbA1c was confirmed for mealtime and post-meal faster aspart vs IAsp (estimated treatment difference [ETD]: 95%CI, -0.02% [-0.11; 0.07] and 0.10% [0.004; 0.19], respectively). Mealtime faster aspart was superior to IAsp for 1-hour PPG increment using a meal test (ETD, -0.90 mmol/L [-1.36; -0.45]; P < 0.001). Self-monitored 1-hour PPG increment favoured faster aspart at breakfast (ETD, -0.58 mmol/L [-0.99; -0.17]; P = 0.006) and across all meals (-0.48 mmol/L [-0.74; -0.21]; P < 0.001). Safety profiles and overall rate of severe or blood glucose-confirmed hypoglycaemia were similar between treatments, but significantly less hypoglycaemia was seen 3 to 4 hours after meals with mealtime faster aspart. CONCLUSION: Mealtime and post-meal faster aspart in conjunction with insulin degludec provided effective glycaemic control compared with IAsp, with no increased safety risk. Mealtime faster aspart provided PPG control superior to that of IAsp. SN - 1463-1326 UR - https://www.unboundmedicine.com/medline/citation/30259644/Fast_acting_insulin_aspart_versus_insulin_aspart_in_the_setting_of_insulin_degludec_treated_type_1_diabetes:_Efficacy_and_safety_from_a_randomized_double_blind_trial_ L2 - https://doi.org/10.1111/dom.13545 DB - PRIME DP - Unbound Medicine ER -