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Effect of two starting insulin regimens in patients with type II diabetes not controlled on a combination of oral antihyperglycemic medications.
Exp Clin Endocrinol Diabetes 2009; 117(5):223-9EC

Abstract

In an open-label, 24-week, parallel-group study, 135 patients inadequately controlled with oral antihyperglycemic medications (OAMs) were treated with maximally tolerated doses of metformin and glibenclamide for at least 8 weeks and then randomized to bedtime neutral protamine Hagedorn (NPH) insulin plus maximally tolerated dose of glibenclamide BID (glib/NPH group) or insulin lispro mix 50 (50% lispro, 50% insulin lispro protamine suspension [ILPS]) pre-breakfast and lispro mix 25 (25% lispro, 75% ILPS) pre-dinner (LM50/LM25 group) (both OAMs discontinued). The LM50/LM25 group had significantly lower 2-hour postprandial BG (both meals combined) compared with glib/NPH after 12 (11.70+/-3.40 mmol/L vs. 13.15+/-2.44 mmol/L, p=0.010) and 24 weeks (11.13+/-3.31 mmol/L vs. 14.46+/-2.93 mmol/L, p =0.0001). Both regimens significantly decreased HbA1c. The reduction was greater with LM50/LM25 (-1.31+/-2% vs. -0.5+/-1.6%; P=0.01). At endpoint, the overall hypoglycemia rate increased with LM50/LM25 and decreased with glib/NPH compared with baseline (0.22+/-0.9 vs. -0.08+/-0.72 episodes/patient/30 days; p =0.037). Treatment with LM50/LM25 compared with glib/NPH in patients with inadequate control on combined OAMs yielded better postprandial and overall glycemic control with a higher rate of hypoglycemia.

Authors+Show Affiliations

Lilly Area Medical Center Vienna, Kölblgasse 8-10, Vienna, Austria. milicevic_zvonko@lilly.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

19301232

Citation

Milicevic, Z, et al. "Effect of Two Starting Insulin Regimens in Patients With Type II Diabetes Not Controlled On a Combination of Oral Antihyperglycemic Medications." Experimental and Clinical Endocrinology & Diabetes : Official Journal, German Society of Endocrinology [and] German Diabetes Association, vol. 117, no. 5, 2009, pp. 223-9.
Milicevic Z, Hancu N, Car N, et al. Effect of two starting insulin regimens in patients with type II diabetes not controlled on a combination of oral antihyperglycemic medications. Exp Clin Endocrinol Diabetes. 2009;117(5):223-9.
Milicevic, Z., Hancu, N., Car, N., Ivanyi, T., Schwarzenhofer, M., & Jermendy, G. (2009). Effect of two starting insulin regimens in patients with type II diabetes not controlled on a combination of oral antihyperglycemic medications. Experimental and Clinical Endocrinology & Diabetes : Official Journal, German Society of Endocrinology [and] German Diabetes Association, 117(5), pp. 223-9. doi:10.1055/s-0028-1128126.
Milicevic Z, et al. Effect of Two Starting Insulin Regimens in Patients With Type II Diabetes Not Controlled On a Combination of Oral Antihyperglycemic Medications. Exp Clin Endocrinol Diabetes. 2009;117(5):223-9. PubMed PMID: 19301232.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effect of two starting insulin regimens in patients with type II diabetes not controlled on a combination of oral antihyperglycemic medications. AU - Milicevic,Z, AU - Hancu,N, AU - Car,N, AU - Ivanyi,T, AU - Schwarzenhofer,M, AU - Jermendy,G, Y1 - 2009/03/19/ PY - 2009/3/21/entrez PY - 2009/3/21/pubmed PY - 2009/7/30/medline SP - 223 EP - 9 JF - Experimental and clinical endocrinology & diabetes : official journal, German Society of Endocrinology [and] German Diabetes Association JO - Exp. Clin. Endocrinol. Diabetes VL - 117 IS - 5 N2 - In an open-label, 24-week, parallel-group study, 135 patients inadequately controlled with oral antihyperglycemic medications (OAMs) were treated with maximally tolerated doses of metformin and glibenclamide for at least 8 weeks and then randomized to bedtime neutral protamine Hagedorn (NPH) insulin plus maximally tolerated dose of glibenclamide BID (glib/NPH group) or insulin lispro mix 50 (50% lispro, 50% insulin lispro protamine suspension [ILPS]) pre-breakfast and lispro mix 25 (25% lispro, 75% ILPS) pre-dinner (LM50/LM25 group) (both OAMs discontinued). The LM50/LM25 group had significantly lower 2-hour postprandial BG (both meals combined) compared with glib/NPH after 12 (11.70+/-3.40 mmol/L vs. 13.15+/-2.44 mmol/L, p=0.010) and 24 weeks (11.13+/-3.31 mmol/L vs. 14.46+/-2.93 mmol/L, p =0.0001). Both regimens significantly decreased HbA1c. The reduction was greater with LM50/LM25 (-1.31+/-2% vs. -0.5+/-1.6%; P=0.01). At endpoint, the overall hypoglycemia rate increased with LM50/LM25 and decreased with glib/NPH compared with baseline (0.22+/-0.9 vs. -0.08+/-0.72 episodes/patient/30 days; p =0.037). Treatment with LM50/LM25 compared with glib/NPH in patients with inadequate control on combined OAMs yielded better postprandial and overall glycemic control with a higher rate of hypoglycemia. SN - 1439-3646 UR - https://www.unboundmedicine.com/medline/citation/19301232/Effect_of_two_starting_insulin_regimens_in_patients_with_type_II_diabetes_not_controlled_on_a_combination_of_oral_antihyperglycemic_medications_ L2 - http://www.thieme-connect.com/DOI/DOI?10.1055/s-0028-1128126 DB - PRIME DP - Unbound Medicine ER -