A 32-Week Randomized Comparison of Stepwise Insulin Intensification of Biphasic Insulin Aspart (BIAsp 30) Versus Basal–Bolus Therapy in Insulin-Naïve Patients with Type 2 Diabetes

Sultan Linjawi, Byung Wan Lee, Ömür Tabak, Susanna Lövdahl, Shanti Werther, Salahedeen Abusnana

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

Introduction: This 32-week, open-label, randomized, parallel-group, multinational trial aimed to compare the efficacy and safety of stepwise insulin intensification of biphasic insulin aspart 30 (BIAsp 30) relative to stepwise intensification of a basal–bolus regimen in insulin-naïve adults with type 2 diabetes (T2D) who continued pretrial treatment with metformin and sulfonylurea. Methods: Adults with T2D were randomized into one of two treatment arms for 32 weeks: (1) BIAsp 30 once daily (OD), with the possibility of stepwise treatment intensification up to BIAsp 30 three times daily (TID); (2) insulin glargine OD, with the possibility of stepwise treatment intensification with insulin aspart up to TID. The primary endpoint was change from baseline in HbA1c after 32 weeks. Results: After 32 weeks, the estimated mean change in HbA1c from baseline was statistically significantly lower in the BIAsp 30 arm (− 1.18%) versus basal–bolus (− 1.36%) [estimated treatment difference 0.18%; 95% confidence interval (95% CI) 0.01; 0.36; p < 0.05]. The proportion of patients with HbA1c below 7.0% was statistically significantly lower with BIAsp 30 (42.9%) compared with basal–bolus (56.9%) (odds ratio 0.58; 95% CI 0.37; 0.89; p = 0.01). The overall rate of severe or blood glucose (BG)-confirmed hypoglycemic events was numerically lower for BIAsp 30 compared with basal–bolus, and a statistically significantly lower rate in nocturnal severe or BG-confirmed hypoglycemia in the BIAsp 30 arm relative to basal–bolus was observed: estimated rate ratio 0.32 (95% CI 0.13; 0.79), p = 0.0131. The proportion of patients with adverse events was similar in both treatment arms. Conclusion: Insulin intensification with BIAsp 30 and basal–bolus showed an improvement in glycemic control; the change in HbA1c was statistically significantly lower for BIAsp 30 compared to basal–bolus. Basal–bolus treatment was accompanied by a numerically, and statistically significantly, higher rate of overall and nocturnal severe or BG-confirmed hypoglycemia, respectively, compared with BIAsp 30. Funding: Novo Nordisk A/S. Trial Registration: ClinicalTrials.gov identifier, NCT02453685.

Original languageEnglish
JournalDiabetes Therapy
Volume9
Issue number1
DOIs
Publication statusPublished - 2018 Feb 1

Fingerprint

Insulin Aspart
Biphasic Insulins
Type 2 Diabetes Mellitus
Insulin
Therapeutics
Blood Glucose
Confidence Intervals
Hypoglycemia
Metformin
Hypoglycemic Agents

All Science Journal Classification (ASJC) codes

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism

Cite this

@article{96a57a8b64424d6db0111135c8cf92cb,
title = "A 32-Week Randomized Comparison of Stepwise Insulin Intensification of Biphasic Insulin Aspart (BIAsp 30) Versus Basal–Bolus Therapy in Insulin-Na{\"i}ve Patients with Type 2 Diabetes",
abstract = "Introduction: This 32-week, open-label, randomized, parallel-group, multinational trial aimed to compare the efficacy and safety of stepwise insulin intensification of biphasic insulin aspart 30 (BIAsp 30) relative to stepwise intensification of a basal–bolus regimen in insulin-na{\"i}ve adults with type 2 diabetes (T2D) who continued pretrial treatment with metformin and sulfonylurea. Methods: Adults with T2D were randomized into one of two treatment arms for 32 weeks: (1) BIAsp 30 once daily (OD), with the possibility of stepwise treatment intensification up to BIAsp 30 three times daily (TID); (2) insulin glargine OD, with the possibility of stepwise treatment intensification with insulin aspart up to TID. The primary endpoint was change from baseline in HbA1c after 32 weeks. Results: After 32 weeks, the estimated mean change in HbA1c from baseline was statistically significantly lower in the BIAsp 30 arm (− 1.18{\%}) versus basal–bolus (− 1.36{\%}) [estimated treatment difference 0.18{\%}; 95{\%} confidence interval (95{\%} CI) 0.01; 0.36; p < 0.05]. The proportion of patients with HbA1c below 7.0{\%} was statistically significantly lower with BIAsp 30 (42.9{\%}) compared with basal–bolus (56.9{\%}) (odds ratio 0.58; 95{\%} CI 0.37; 0.89; p = 0.01). The overall rate of severe or blood glucose (BG)-confirmed hypoglycemic events was numerically lower for BIAsp 30 compared with basal–bolus, and a statistically significantly lower rate in nocturnal severe or BG-confirmed hypoglycemia in the BIAsp 30 arm relative to basal–bolus was observed: estimated rate ratio 0.32 (95{\%} CI 0.13; 0.79), p = 0.0131. The proportion of patients with adverse events was similar in both treatment arms. Conclusion: Insulin intensification with BIAsp 30 and basal–bolus showed an improvement in glycemic control; the change in HbA1c was statistically significantly lower for BIAsp 30 compared to basal–bolus. Basal–bolus treatment was accompanied by a numerically, and statistically significantly, higher rate of overall and nocturnal severe or BG-confirmed hypoglycemia, respectively, compared with BIAsp 30. Funding: Novo Nordisk A/S. Trial Registration: ClinicalTrials.gov identifier, NCT02453685.",
author = "Sultan Linjawi and Lee, {Byung Wan} and {\"O}m{\"u}r Tabak and Susanna L{\"o}vdahl and Shanti Werther and Salahedeen Abusnana",
year = "2018",
month = "2",
day = "1",
doi = "10.1007/s13300-017-0334-8",
language = "English",
volume = "9",
journal = "Diabetes Therapy",
issn = "1869-6953",
publisher = "Springer Publishing Company",
number = "1",

}

A 32-Week Randomized Comparison of Stepwise Insulin Intensification of Biphasic Insulin Aspart (BIAsp 30) Versus Basal–Bolus Therapy in Insulin-Naïve Patients with Type 2 Diabetes. / Linjawi, Sultan; Lee, Byung Wan; Tabak, Ömür; Lövdahl, Susanna; Werther, Shanti; Abusnana, Salahedeen.

In: Diabetes Therapy, Vol. 9, No. 1, 01.02.2018.

Research output: Contribution to journalArticle

TY - JOUR

T1 - A 32-Week Randomized Comparison of Stepwise Insulin Intensification of Biphasic Insulin Aspart (BIAsp 30) Versus Basal–Bolus Therapy in Insulin-Naïve Patients with Type 2 Diabetes

AU - Linjawi, Sultan

AU - Lee, Byung Wan

AU - Tabak, Ömür

AU - Lövdahl, Susanna

AU - Werther, Shanti

AU - Abusnana, Salahedeen

PY - 2018/2/1

Y1 - 2018/2/1

N2 - Introduction: This 32-week, open-label, randomized, parallel-group, multinational trial aimed to compare the efficacy and safety of stepwise insulin intensification of biphasic insulin aspart 30 (BIAsp 30) relative to stepwise intensification of a basal–bolus regimen in insulin-naïve adults with type 2 diabetes (T2D) who continued pretrial treatment with metformin and sulfonylurea. Methods: Adults with T2D were randomized into one of two treatment arms for 32 weeks: (1) BIAsp 30 once daily (OD), with the possibility of stepwise treatment intensification up to BIAsp 30 three times daily (TID); (2) insulin glargine OD, with the possibility of stepwise treatment intensification with insulin aspart up to TID. The primary endpoint was change from baseline in HbA1c after 32 weeks. Results: After 32 weeks, the estimated mean change in HbA1c from baseline was statistically significantly lower in the BIAsp 30 arm (− 1.18%) versus basal–bolus (− 1.36%) [estimated treatment difference 0.18%; 95% confidence interval (95% CI) 0.01; 0.36; p < 0.05]. The proportion of patients with HbA1c below 7.0% was statistically significantly lower with BIAsp 30 (42.9%) compared with basal–bolus (56.9%) (odds ratio 0.58; 95% CI 0.37; 0.89; p = 0.01). The overall rate of severe or blood glucose (BG)-confirmed hypoglycemic events was numerically lower for BIAsp 30 compared with basal–bolus, and a statistically significantly lower rate in nocturnal severe or BG-confirmed hypoglycemia in the BIAsp 30 arm relative to basal–bolus was observed: estimated rate ratio 0.32 (95% CI 0.13; 0.79), p = 0.0131. The proportion of patients with adverse events was similar in both treatment arms. Conclusion: Insulin intensification with BIAsp 30 and basal–bolus showed an improvement in glycemic control; the change in HbA1c was statistically significantly lower for BIAsp 30 compared to basal–bolus. Basal–bolus treatment was accompanied by a numerically, and statistically significantly, higher rate of overall and nocturnal severe or BG-confirmed hypoglycemia, respectively, compared with BIAsp 30. Funding: Novo Nordisk A/S. Trial Registration: ClinicalTrials.gov identifier, NCT02453685.

AB - Introduction: This 32-week, open-label, randomized, parallel-group, multinational trial aimed to compare the efficacy and safety of stepwise insulin intensification of biphasic insulin aspart 30 (BIAsp 30) relative to stepwise intensification of a basal–bolus regimen in insulin-naïve adults with type 2 diabetes (T2D) who continued pretrial treatment with metformin and sulfonylurea. Methods: Adults with T2D were randomized into one of two treatment arms for 32 weeks: (1) BIAsp 30 once daily (OD), with the possibility of stepwise treatment intensification up to BIAsp 30 three times daily (TID); (2) insulin glargine OD, with the possibility of stepwise treatment intensification with insulin aspart up to TID. The primary endpoint was change from baseline in HbA1c after 32 weeks. Results: After 32 weeks, the estimated mean change in HbA1c from baseline was statistically significantly lower in the BIAsp 30 arm (− 1.18%) versus basal–bolus (− 1.36%) [estimated treatment difference 0.18%; 95% confidence interval (95% CI) 0.01; 0.36; p < 0.05]. The proportion of patients with HbA1c below 7.0% was statistically significantly lower with BIAsp 30 (42.9%) compared with basal–bolus (56.9%) (odds ratio 0.58; 95% CI 0.37; 0.89; p = 0.01). The overall rate of severe or blood glucose (BG)-confirmed hypoglycemic events was numerically lower for BIAsp 30 compared with basal–bolus, and a statistically significantly lower rate in nocturnal severe or BG-confirmed hypoglycemia in the BIAsp 30 arm relative to basal–bolus was observed: estimated rate ratio 0.32 (95% CI 0.13; 0.79), p = 0.0131. The proportion of patients with adverse events was similar in both treatment arms. Conclusion: Insulin intensification with BIAsp 30 and basal–bolus showed an improvement in glycemic control; the change in HbA1c was statistically significantly lower for BIAsp 30 compared to basal–bolus. Basal–bolus treatment was accompanied by a numerically, and statistically significantly, higher rate of overall and nocturnal severe or BG-confirmed hypoglycemia, respectively, compared with BIAsp 30. Funding: Novo Nordisk A/S. Trial Registration: ClinicalTrials.gov identifier, NCT02453685.

UR - http://www.scopus.com/inward/record.url?scp=85041493580&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85041493580&partnerID=8YFLogxK

U2 - 10.1007/s13300-017-0334-8

DO - 10.1007/s13300-017-0334-8

M3 - Article

AN - SCOPUS:85041493580

VL - 9

JO - Diabetes Therapy

JF - Diabetes Therapy

SN - 1869-6953

IS - 1

ER -