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Adding fast-acting insulin aspart to basal insulin significantly improved glycaemic control in patients with type 2 diabetes: A randomized, 18-week, open-label, phase 3 trial (onset 3).
Diabetes Obes Metab. 2017 10; 19(10):1389-1396.DO

Abstract

AIM

To confirm glycaemic control superiority of mealtime fast-acting insulin aspart (faster aspart) in a basal-bolus (BB) regimen vs basal-only insulin.

MATERIALS AND METHODS

In this open-label, randomized, 18-week trial (51 sites; 6 countries), adults (n = 236) with inadequately controlled type 2 diabetes (T2D; mean glycosylated haemoglobin [HbA1c] ± SD: 7.9% ± 0.7% [63.1 ± 7.5 mmol/mol]) receiving basal insulin and oral antidiabetic drugs underwent 8-week optimization of prior once-daily basal insulin followed by randomization 1:1 to either a BB regimen with faster aspart (n = 116) or continuation of once-daily basal insulin (n = 120), both with metformin. Primary endpoint was HbA1c change from baseline after 18 weeks of treatment. Secondary endpoints included: postprandial plasma glucose (PPG) change and overall PPG increment (all meals); weight; treatment-emergent adverse events; hypoglycaemic episodes.

RESULTS

HbA1c decreased from 7.9% (63.2 mmol/mol) to 6.8% (50.7 mmol/mol; BB group) and from 7.9% (63.2 mmol/mol) to 7.7% (60.7 mmol/mol; basal-only group); estimated treatment difference [95% confidence interval] -0.94% [-1.17; -0.72]; -10.3 mmol/mol [-12.8; -7.8]; P < .0001. Reductions from baseline in overall mean 2-hour PPG and overall PPG increment for all meals (self-measured plasma glucose profiles) were statistically significant in favour of BB treatment (P < .0001). Severe/blood glucose confirmed hypoglycaemia rate (12.8 vs 2.0 episodes per patient-years of exposure), total daily insulin (1.2 vs 0.6 U/kg) and weight gain (1.8 vs 0.2 kg) were greater with BB than with basal-only treatment.

CONCLUSIONS

In T2D, faster aspart in a BB regimen provided superior glycaemic control as compared with basal-only insulin, but with an increase in the frequency of hypoglycaemia and modest weight gain.

Authors+Show Affiliations

Endocrine and Metabolic Consultants, Rockville, Maryland.University of Texas Health Science Center, San Antonio, Texas. Audie L Murphy VA Hospital, San Antonio, Texas.Hospital General Regional 110, Guadalajara, Mexico.Novo Nordisk A/S, Søborg, Denmark.Novo Nordisk A/S, Søborg, Denmark.General Hospital, Novo Mesto, Slovenia.

Pub Type(s)

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

Language

eng

PubMed ID

28345792

Citation

Rodbard, Helena W., et al. "Adding Fast-acting Insulin Aspart to Basal Insulin Significantly Improved Glycaemic Control in Patients With Type 2 Diabetes: a Randomized, 18-week, Open-label, Phase 3 Trial (onset 3)." Diabetes, Obesity & Metabolism, vol. 19, no. 10, 2017, pp. 1389-1396.
Rodbard HW, Tripathy D, Vidrio Velázquez M, et al. Adding fast-acting insulin aspart to basal insulin significantly improved glycaemic control in patients with type 2 diabetes: A randomized, 18-week, open-label, phase 3 trial (onset 3). Diabetes Obes Metab. 2017;19(10):1389-1396.
Rodbard, H. W., Tripathy, D., Vidrio Velázquez, M., Demissie, M., Tamer, S. C., & Piletič, M. (2017). Adding fast-acting insulin aspart to basal insulin significantly improved glycaemic control in patients with type 2 diabetes: A randomized, 18-week, open-label, phase 3 trial (onset 3). Diabetes, Obesity & Metabolism, 19(10), 1389-1396. https://doi.org/10.1111/dom.12955
Rodbard HW, et al. Adding Fast-acting Insulin Aspart to Basal Insulin Significantly Improved Glycaemic Control in Patients With Type 2 Diabetes: a Randomized, 18-week, Open-label, Phase 3 Trial (onset 3). Diabetes Obes Metab. 2017;19(10):1389-1396. PubMed PMID: 28345792.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Adding fast-acting insulin aspart to basal insulin significantly improved glycaemic control in patients with type 2 diabetes: A randomized, 18-week, open-label, phase 3 trial (onset 3). AU - Rodbard,Helena W, AU - Tripathy,Devjit, AU - Vidrio Velázquez,Maricela, AU - Demissie,Marek, AU - Tamer,Søren C, AU - Piletič,Milivoj, Y1 - 2017/07/06/ PY - 2016/11/15/received PY - 2017/03/13/revised PY - 2017/03/22/accepted PY - 2017/3/28/pubmed PY - 2018/7/13/medline PY - 2017/3/28/entrez KW - glycaemic control KW - hypoglycaemia KW - insulin therapy KW - phase 3 study KW - randomized trial KW - type 2 diabetes SP - 1389 EP - 1396 JF - Diabetes, obesity & metabolism JO - Diabetes Obes Metab VL - 19 IS - 10 N2 - AIM: To confirm glycaemic control superiority of mealtime fast-acting insulin aspart (faster aspart) in a basal-bolus (BB) regimen vs basal-only insulin. MATERIALS AND METHODS: In this open-label, randomized, 18-week trial (51 sites; 6 countries), adults (n = 236) with inadequately controlled type 2 diabetes (T2D; mean glycosylated haemoglobin [HbA1c] ± SD: 7.9% ± 0.7% [63.1 ± 7.5 mmol/mol]) receiving basal insulin and oral antidiabetic drugs underwent 8-week optimization of prior once-daily basal insulin followed by randomization 1:1 to either a BB regimen with faster aspart (n = 116) or continuation of once-daily basal insulin (n = 120), both with metformin. Primary endpoint was HbA1c change from baseline after 18 weeks of treatment. Secondary endpoints included: postprandial plasma glucose (PPG) change and overall PPG increment (all meals); weight; treatment-emergent adverse events; hypoglycaemic episodes. RESULTS: HbA1c decreased from 7.9% (63.2 mmol/mol) to 6.8% (50.7 mmol/mol; BB group) and from 7.9% (63.2 mmol/mol) to 7.7% (60.7 mmol/mol; basal-only group); estimated treatment difference [95% confidence interval] -0.94% [-1.17; -0.72]; -10.3 mmol/mol [-12.8; -7.8]; P < .0001. Reductions from baseline in overall mean 2-hour PPG and overall PPG increment for all meals (self-measured plasma glucose profiles) were statistically significant in favour of BB treatment (P < .0001). Severe/blood glucose confirmed hypoglycaemia rate (12.8 vs 2.0 episodes per patient-years of exposure), total daily insulin (1.2 vs 0.6 U/kg) and weight gain (1.8 vs 0.2 kg) were greater with BB than with basal-only treatment. CONCLUSIONS: In T2D, faster aspart in a BB regimen provided superior glycaemic control as compared with basal-only insulin, but with an increase in the frequency of hypoglycaemia and modest weight gain. SN - 1463-1326 UR - https://www.unboundmedicine.com/medline/citation/28345792/Adding_fast_acting_insulin_aspart_to_basal_insulin_significantly_improved_glycaemic_control_in_patients_with_type_2_diabetes:_A_randomized_18_week_open_label_phase_3_trial__onset_3__ L2 - https://doi.org/10.1111/dom.12955 DB - PRIME DP - Unbound Medicine ER -