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Lower fasting blood glucose, glucose variability and nocturnal hypoglycaemia with glargine vs NPH basal insulin in subjects with Type 1 diabetes.
Nutr Metab Cardiovasc Dis. 2009 Oct; 19(8):571-9.NM

Abstract

BACKGROUND AND AIMS

To compare switching from NPH insulin (NPH) to insulin glargine (glargine) with continuing NPH for changes in fasting blood glucose (FBG) in patients with Type 1 diabetes on basal-bolus therapy with insulin lispro as bolus insulin. Secondary objectives included self-monitoring blood glucose, mean daily blood glucose (MDBG) and mean amplitude glucose excursion (MAGE) values alongside changes in HbA(1c) and safety profiles.

METHODS AND RESULTS

This was a 30-week, parallel, open-label, multicentre study. Seven-point profiles were used to calculate MDBG and MAGE. Hypoglycaemia and adverse events were recorded by participants. FBG improved significantly with both glargine (baseline-endpoint change: -28.0 mg/dL; 95% CI: -37.3, -18.7 mg/dL; p<0.001) and NPH (-9.8 mg/dL; 95% CI: -19.1, -0.5 mg/dL; p=0.0374). The improvement was significantly greater with glargine than NPH (mean difference: -18.2 mg/dL; 95% CI: -31.3, -5.2 mg/dL; p=0.0064). MDBG (-10.1 mg/dL; 95% CI: -18.1, -2.1 mg/dL; p=0.0126) and MAGE (-20.0 mg/dL; 95% CI: -34.5, -5.9 mg/dL; p=0.0056) decreased significantly with glargine, but not NPH although endpoint values were no different with the two insulins. Baseline to endpoint change in HbA(1c) was similar (-0.56 vs -0.56%) with no differences at endpoint. Overall hypoglycaemia was no different, but glargine reduced nocturnal hypoglycaemia ("serious episodes" with BG < 42 mg/dl, p=0.006) whereas NPH did not (p=0.123), although endpoint values were no different.

CONCLUSION

Switching from NPH to glargine is well tolerated and results into lower FBG, and lower glucose variability while reducing nocturnal hypoglycaemia. These data provide a rationale for more aggressive titration to target with glargine in Type 1 diabetes.

Authors+Show Affiliations

Department of Internal Medicine, Endocrinology and Metabolism, University of Perugia, Italy. gbolli@unipg.itNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

18676131

Citation

Bolli, G B., et al. "Lower Fasting Blood Glucose, Glucose Variability and Nocturnal Hypoglycaemia With Glargine Vs NPH Basal Insulin in Subjects With Type 1 Diabetes." Nutrition, Metabolism, and Cardiovascular Diseases : NMCD, vol. 19, no. 8, 2009, pp. 571-9.
Bolli GB, Songini M, Trovati M, et al. Lower fasting blood glucose, glucose variability and nocturnal hypoglycaemia with glargine vs NPH basal insulin in subjects with Type 1 diabetes. Nutr Metab Cardiovasc Dis. 2009;19(8):571-9.
Bolli, G. B., Songini, M., Trovati, M., Del Prato, S., Ghirlanda, G., Cordera, R., Trevisan, R., Riccardi, G., & Noacco, C. (2009). Lower fasting blood glucose, glucose variability and nocturnal hypoglycaemia with glargine vs NPH basal insulin in subjects with Type 1 diabetes. Nutrition, Metabolism, and Cardiovascular Diseases : NMCD, 19(8), 571-9. https://doi.org/10.1016/j.numecd.2008.05.003
Bolli GB, et al. Lower Fasting Blood Glucose, Glucose Variability and Nocturnal Hypoglycaemia With Glargine Vs NPH Basal Insulin in Subjects With Type 1 Diabetes. Nutr Metab Cardiovasc Dis. 2009;19(8):571-9. PubMed PMID: 18676131.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Lower fasting blood glucose, glucose variability and nocturnal hypoglycaemia with glargine vs NPH basal insulin in subjects with Type 1 diabetes. AU - Bolli,G B, AU - Songini,M, AU - Trovati,M, AU - Del Prato,S, AU - Ghirlanda,G, AU - Cordera,R, AU - Trevisan,R, AU - Riccardi,G, AU - Noacco,C, Y1 - 2008/08/03/ PY - 2007/11/19/received PY - 2008/05/06/revised PY - 2008/05/24/accepted PY - 2008/8/5/pubmed PY - 2009/12/16/medline PY - 2008/8/5/entrez SP - 571 EP - 9 JF - Nutrition, metabolism, and cardiovascular diseases : NMCD JO - Nutr Metab Cardiovasc Dis VL - 19 IS - 8 N2 - BACKGROUND AND AIMS: To compare switching from NPH insulin (NPH) to insulin glargine (glargine) with continuing NPH for changes in fasting blood glucose (FBG) in patients with Type 1 diabetes on basal-bolus therapy with insulin lispro as bolus insulin. Secondary objectives included self-monitoring blood glucose, mean daily blood glucose (MDBG) and mean amplitude glucose excursion (MAGE) values alongside changes in HbA(1c) and safety profiles. METHODS AND RESULTS: This was a 30-week, parallel, open-label, multicentre study. Seven-point profiles were used to calculate MDBG and MAGE. Hypoglycaemia and adverse events were recorded by participants. FBG improved significantly with both glargine (baseline-endpoint change: -28.0 mg/dL; 95% CI: -37.3, -18.7 mg/dL; p<0.001) and NPH (-9.8 mg/dL; 95% CI: -19.1, -0.5 mg/dL; p=0.0374). The improvement was significantly greater with glargine than NPH (mean difference: -18.2 mg/dL; 95% CI: -31.3, -5.2 mg/dL; p=0.0064). MDBG (-10.1 mg/dL; 95% CI: -18.1, -2.1 mg/dL; p=0.0126) and MAGE (-20.0 mg/dL; 95% CI: -34.5, -5.9 mg/dL; p=0.0056) decreased significantly with glargine, but not NPH although endpoint values were no different with the two insulins. Baseline to endpoint change in HbA(1c) was similar (-0.56 vs -0.56%) with no differences at endpoint. Overall hypoglycaemia was no different, but glargine reduced nocturnal hypoglycaemia ("serious episodes" with BG < 42 mg/dl, p=0.006) whereas NPH did not (p=0.123), although endpoint values were no different. CONCLUSION: Switching from NPH to glargine is well tolerated and results into lower FBG, and lower glucose variability while reducing nocturnal hypoglycaemia. These data provide a rationale for more aggressive titration to target with glargine in Type 1 diabetes. SN - 1590-3729 UR - https://www.unboundmedicine.com/medline/citation/18676131/Lower_fasting_blood_glucose_glucose_variability_and_nocturnal_hypoglycaemia_with_glargine_vs_NPH_basal_insulin_in_subjects_with_Type_1_diabetes_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0939-4753(08)00113-0 DB - PRIME DP - Unbound Medicine ER -