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Insulin glulisine imparts effective glycaemic control in patients with Type 2 diabetes.
Diabetes Res Clin Pract. 2007 May; 76(2):304-12.DR

Abstract

INTRODUCTION

Insulin glulisine (glulisine) was evaluated versus regular human insulin (RHI) in Type 2 diabetes (T2DM) patients.

METHODS

Patients previously on >6 months' continuous insulin treatment aged >or=18 years in a randomized, multinational, controlled, open-label, parallel group, 26-week study received twice-daily NPH insulin and either glulisine (0-15 min before breakfast and dinner; n=448) or RHI (30-45 min before breakfast and dinner; n=442) at least twice daily.

RESULTS

Mean baseline characteristics were similar between groups. There were no differences in baseline to endpoint HbA(1c) reductions (glulisine: -0.32%; RHI: -0.35%; p=0.5726), and the non-inferiority of glulisine versus RHI was demonstrated (difference in adjusted mean change 0.03%; 95% CI: -0.07, 0.13). Postprandially, glulisine lowered plasma glucose significantly more versus RHI at 2h (14.14 mmol/L versus 15.28 mmol/L; p=0.0025) and excursions at 1h (3.99 versus 4.59; p=0.0151) and 2h (4.87 versus 6.03; p=0.0002). No between-group differences occurred in the frequencies and monthly rates of all symptomatic hypoglycaemia; nocturnal hypoglycaemia from Month 4 to treatment end was less frequent with glulisine versus RHI (9.1% versus 14.5%; p=0.029).

CONCLUSION

Glulisine was non-inferior to RHI in reducing HbA(1c) in T2DM. Glulisine demonstrated superior postprandial glucose control and was associated with fewer nocturnal hypoglycaemic episodes, indicating clinical benefits.

Authors+Show Affiliations

The Diabetes Centre, Ipswich Hospital NHS Trust, Suffolk IP4 5PD, United Kingdom. Gerry.Rayman@ipswichhospital.nhs.ukNo affiliation info availableNo affiliation info available

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

17113676

Citation

Rayman, Gerrard, et al. "Insulin Glulisine Imparts Effective Glycaemic Control in Patients With Type 2 Diabetes." Diabetes Research and Clinical Practice, vol. 76, no. 2, 2007, pp. 304-12.
Rayman G, Profozic V, Middle M. Insulin glulisine imparts effective glycaemic control in patients with Type 2 diabetes. Diabetes Res Clin Pract. 2007;76(2):304-12.
Rayman, G., Profozic, V., & Middle, M. (2007). Insulin glulisine imparts effective glycaemic control in patients with Type 2 diabetes. Diabetes Research and Clinical Practice, 76(2), 304-12.
Rayman G, Profozic V, Middle M. Insulin Glulisine Imparts Effective Glycaemic Control in Patients With Type 2 Diabetes. Diabetes Res Clin Pract. 2007;76(2):304-12. PubMed PMID: 17113676.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Insulin glulisine imparts effective glycaemic control in patients with Type 2 diabetes. AU - Rayman,Gerrard, AU - Profozic,Velimir, AU - Middle,Michelle, Y1 - 2006/11/20/ PY - 2006/08/24/received PY - 2006/09/04/accepted PY - 2006/11/23/pubmed PY - 2007/8/21/medline PY - 2006/11/23/entrez SP - 304 EP - 12 JF - Diabetes research and clinical practice JO - Diabetes Res Clin Pract VL - 76 IS - 2 N2 - INTRODUCTION: Insulin glulisine (glulisine) was evaluated versus regular human insulin (RHI) in Type 2 diabetes (T2DM) patients. METHODS: Patients previously on >6 months' continuous insulin treatment aged >or=18 years in a randomized, multinational, controlled, open-label, parallel group, 26-week study received twice-daily NPH insulin and either glulisine (0-15 min before breakfast and dinner; n=448) or RHI (30-45 min before breakfast and dinner; n=442) at least twice daily. RESULTS: Mean baseline characteristics were similar between groups. There were no differences in baseline to endpoint HbA(1c) reductions (glulisine: -0.32%; RHI: -0.35%; p=0.5726), and the non-inferiority of glulisine versus RHI was demonstrated (difference in adjusted mean change 0.03%; 95% CI: -0.07, 0.13). Postprandially, glulisine lowered plasma glucose significantly more versus RHI at 2h (14.14 mmol/L versus 15.28 mmol/L; p=0.0025) and excursions at 1h (3.99 versus 4.59; p=0.0151) and 2h (4.87 versus 6.03; p=0.0002). No between-group differences occurred in the frequencies and monthly rates of all symptomatic hypoglycaemia; nocturnal hypoglycaemia from Month 4 to treatment end was less frequent with glulisine versus RHI (9.1% versus 14.5%; p=0.029). CONCLUSION: Glulisine was non-inferior to RHI in reducing HbA(1c) in T2DM. Glulisine demonstrated superior postprandial glucose control and was associated with fewer nocturnal hypoglycaemic episodes, indicating clinical benefits. SN - 0168-8227 UR - https://www.unboundmedicine.com/medline/citation/17113676/Insulin_glulisine_imparts_effective_glycaemic_control_in_patients_with_Type_2_diabetes_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0168-8227(06)00391-3 DB - PRIME DP - Unbound Medicine ER -