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Modulation of insulin dose titration using a hypoglycaemia-sensitive algorithm: insulin glargine versus neutral protamine Hagedorn insulin in insulin-naïve people with type 2 diabetes.
Diabetes Obes Metab. 2015 Jan; 17(1):15-22.DO

Abstract

AIMS

To examine whether insulin glargine can lead to better control of glycated haemoglobin (HbA1c) than that achieved by neutral protamine Hagedorn (NPH) insulin, using a protocol designed to limit nocturnal hypoglycaemia.

METHODS

The present study, the Least One Oral Antidiabetic Drug Treatment (LANCELOT) Study, was a 36-week, randomized, open-label, parallel-arm study conducted in Europe, Asia, the Middle East and South America. Participants were randomized (1:1) to begin glargine or NPH, on background of metformin with glimepiride. Weekly insulin titration aimed to achieve median prebreakfast and nocturnal plasma glucose levels ≤5.5 mmol/l, while limiting values ≤4.4 mmol/l.

RESULTS

The efficacy population (n = 701) had a mean age of 57 years, a mean body mass index of 29.8 kg/m², a mean duration of diabetes of 9.2 years and a mean HbA1c level of 8.2% (66 mmol/mol). At treatment end, HbA1c values and the proportion of participants with HbA1c <7.0 % (<53 mmol/mol) were not significantly different for glargine [7.1 % (54 mmol/mol) and 50.3%] versus NPH [7.2 % (55 mmol/mol) and 44.3%]. The rate of symptomatic nocturnal hypoglycaemia, confirmed by plasma glucose ≤3.9 or ≤3.1 mmol/l, was 29 and 48% less with glargine than with NPH insulin. Other outcomes were similar between the groups.

CONCLUSION

Insulin glargine was not superior to NPH insulin in improving glycaemic control. The insulin dosing algorithm was not sufficient to equalize nocturnal hypoglycaemia between the two insulins. This study confirms, in a globally heterogeneous population, the reduction achieved in nocturnal hypoglycaemia while attaining good glycaemic control with insulin glargine compared with NPH, even when titrating basal insulin to prevent nocturnal hypoglycaemia rather than treating according to normal fasting glucose levels.

Authors+Show Affiliations

Institute for Cellular Medicine - Diabetes, Newcastle University, Newcastle upon Tyne, UK.No 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

24957785

Citation

Home, P D., et al. "Modulation of Insulin Dose Titration Using a Hypoglycaemia-sensitive Algorithm: Insulin Glargine Versus Neutral Protamine Hagedorn Insulin in Insulin-naïve People With Type 2 Diabetes." Diabetes, Obesity & Metabolism, vol. 17, no. 1, 2015, pp. 15-22.
Home PD, Bolli GB, Mathieu C, et al. Modulation of insulin dose titration using a hypoglycaemia-sensitive algorithm: insulin glargine versus neutral protamine Hagedorn insulin in insulin-naïve people with type 2 diabetes. Diabetes Obes Metab. 2015;17(1):15-22.
Home, P. D., Bolli, G. B., Mathieu, C., Deerochanawong, C., Landgraf, W., Candelas, C., Pilorget, V., Dain, M. P., & Riddle, M. C. (2015). Modulation of insulin dose titration using a hypoglycaemia-sensitive algorithm: insulin glargine versus neutral protamine Hagedorn insulin in insulin-naïve people with type 2 diabetes. Diabetes, Obesity & Metabolism, 17(1), 15-22. https://doi.org/10.1111/dom.12329
Home PD, et al. Modulation of Insulin Dose Titration Using a Hypoglycaemia-sensitive Algorithm: Insulin Glargine Versus Neutral Protamine Hagedorn Insulin in Insulin-naïve People With Type 2 Diabetes. Diabetes Obes Metab. 2015;17(1):15-22. PubMed PMID: 24957785.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Modulation of insulin dose titration using a hypoglycaemia-sensitive algorithm: insulin glargine versus neutral protamine Hagedorn insulin in insulin-naïve people with type 2 diabetes. AU - Home,P D, AU - Bolli,G B, AU - Mathieu,C, AU - Deerochanawong,C, AU - Landgraf,W, AU - Candelas,C, AU - Pilorget,V, AU - Dain,M-P, AU - Riddle,M C, Y1 - 2014/07/12/ PY - 2013/12/05/received PY - 2014/04/21/revised PY - 2014/06/09/accepted PY - 2014/6/25/entrez PY - 2014/6/25/pubmed PY - 2015/7/15/medline KW - NPH insulin KW - hypoglycaemia-sensitive algorithm KW - insulin glargine SP - 15 EP - 22 JF - Diabetes, obesity & metabolism JO - Diabetes Obes Metab VL - 17 IS - 1 N2 - AIMS: To examine whether insulin glargine can lead to better control of glycated haemoglobin (HbA1c) than that achieved by neutral protamine Hagedorn (NPH) insulin, using a protocol designed to limit nocturnal hypoglycaemia. METHODS: The present study, the Least One Oral Antidiabetic Drug Treatment (LANCELOT) Study, was a 36-week, randomized, open-label, parallel-arm study conducted in Europe, Asia, the Middle East and South America. Participants were randomized (1:1) to begin glargine or NPH, on background of metformin with glimepiride. Weekly insulin titration aimed to achieve median prebreakfast and nocturnal plasma glucose levels ≤5.5 mmol/l, while limiting values ≤4.4 mmol/l. RESULTS: The efficacy population (n = 701) had a mean age of 57 years, a mean body mass index of 29.8 kg/m², a mean duration of diabetes of 9.2 years and a mean HbA1c level of 8.2% (66 mmol/mol). At treatment end, HbA1c values and the proportion of participants with HbA1c <7.0 % (<53 mmol/mol) were not significantly different for glargine [7.1 % (54 mmol/mol) and 50.3%] versus NPH [7.2 % (55 mmol/mol) and 44.3%]. The rate of symptomatic nocturnal hypoglycaemia, confirmed by plasma glucose ≤3.9 or ≤3.1 mmol/l, was 29 and 48% less with glargine than with NPH insulin. Other outcomes were similar between the groups. CONCLUSION: Insulin glargine was not superior to NPH insulin in improving glycaemic control. The insulin dosing algorithm was not sufficient to equalize nocturnal hypoglycaemia between the two insulins. This study confirms, in a globally heterogeneous population, the reduction achieved in nocturnal hypoglycaemia while attaining good glycaemic control with insulin glargine compared with NPH, even when titrating basal insulin to prevent nocturnal hypoglycaemia rather than treating according to normal fasting glucose levels. SN - 1463-1326 UR - https://www.unboundmedicine.com/medline/citation/24957785/Modulation_of_insulin_dose_titration_using_a_hypoglycaemia_sensitive_algorithm:_insulin_glargine_versus_neutral_protamine_Hagedorn_insulin_in_insulin_naïve_people_with_type_2_diabetes_ L2 - https://doi.org/10.1111/dom.12329 DB - PRIME DP - Unbound Medicine ER -