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Biphasic insulin aspart 30 plus metformin: an effective combination in type 2 diabetes.
Diabetes Obes Metab 2006; 8(1):39-48DO

Abstract

AIM

This study compared glycaemic control achieved with biphasic insulin aspart 30 (BIAsp 30) monotherapy, BIAsp 30 plus metformin and glibenclamide plus metformin in patients with type 2 diabetes not adequately controlled with metformin.

METHODS

In this multinational, open-labelled, parallel group, 16-week trial, 341 patients (patients not adequately controlled with metformin for at least 1 month) with type 2 diabetes were studied. Patients were randomized to receive BIAsp 30, twice daily (n = 107 exposed to treatment), or BIAsp 30, twice daily, plus metformin (n = 108) or glibenclamide plus metformin (n = 114). The primary endpoint was HbA(1c) at end of trial; adverse events, hypoglycaemia episodes, blood lipids and weight were also monitored.

RESULTS

In the total population (HbA(1c) 7.5-13.0% at screening), end-of-trial HbA(1c) levels were lower in patients receiving BIAsp 30 plus metformin compared with those receiving BIAsp 30 only [mean treatment difference (+/-s.e.m), 0.39 +/- 0.15%, p = 0.007]. In a subpopulation (HbA(1c) > or = 9.0% at baseline, n = 193), patients receiving BIAsp 30 plus metformin had significantly lower HbA(1c) levels at the end of the trial compared with those receiving glibenclamide plus metformin (treatment difference, 0.46 +/- 0.21%, p = 0.027). Mean body weight (+/-s.d) at the end of the trial was significantly lower in patients receiving glibenclamide plus metformin compared with those receiving BIAsp 30 only (84.3 +/- 13.3 kg vs. 88.9 +/- 16.9 kg, p < 0.001). No major hypoglycaemic episodes were recorded during the trial, and incidence rates for minor and symptoms-only hypoglycaemia were low and similar between treatment groups (0.03-0.04 events/patient/week).

CONCLUSION

BIAsp 30 added to metformin could be an appropriate therapeutic option for achieving good glycaemic control, compared with the addition of a second oral agent, particularly where HbA(1c) > or = 9%.

Authors+Show Affiliations

Internal Clinic 2nd Medical Faculty, Prague, Czech Republic. milan.kvapil@lfmotol.cuni.czNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

16367881

Citation

Kvapil, M, et al. "Biphasic Insulin Aspart 30 Plus Metformin: an Effective Combination in Type 2 Diabetes." Diabetes, Obesity & Metabolism, vol. 8, no. 1, 2006, pp. 39-48.
Kvapil M, Swatko A, Hilberg C, et al. Biphasic insulin aspart 30 plus metformin: an effective combination in type 2 diabetes. Diabetes Obes Metab. 2006;8(1):39-48.
Kvapil, M., Swatko, A., Hilberg, C., & Shestakova, M. (2006). Biphasic insulin aspart 30 plus metformin: an effective combination in type 2 diabetes. Diabetes, Obesity & Metabolism, 8(1), pp. 39-48.
Kvapil M, et al. Biphasic Insulin Aspart 30 Plus Metformin: an Effective Combination in Type 2 Diabetes. Diabetes Obes Metab. 2006;8(1):39-48. PubMed PMID: 16367881.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Biphasic insulin aspart 30 plus metformin: an effective combination in type 2 diabetes. AU - Kvapil,M, AU - Swatko,A, AU - Hilberg,C, AU - Shestakova,M, PY - 2005/12/22/pubmed PY - 2006/5/4/medline PY - 2005/12/22/entrez SP - 39 EP - 48 JF - Diabetes, obesity & metabolism JO - Diabetes Obes Metab VL - 8 IS - 1 N2 - AIM: This study compared glycaemic control achieved with biphasic insulin aspart 30 (BIAsp 30) monotherapy, BIAsp 30 plus metformin and glibenclamide plus metformin in patients with type 2 diabetes not adequately controlled with metformin. METHODS: In this multinational, open-labelled, parallel group, 16-week trial, 341 patients (patients not adequately controlled with metformin for at least 1 month) with type 2 diabetes were studied. Patients were randomized to receive BIAsp 30, twice daily (n = 107 exposed to treatment), or BIAsp 30, twice daily, plus metformin (n = 108) or glibenclamide plus metformin (n = 114). The primary endpoint was HbA(1c) at end of trial; adverse events, hypoglycaemia episodes, blood lipids and weight were also monitored. RESULTS: In the total population (HbA(1c) 7.5-13.0% at screening), end-of-trial HbA(1c) levels were lower in patients receiving BIAsp 30 plus metformin compared with those receiving BIAsp 30 only [mean treatment difference (+/-s.e.m), 0.39 +/- 0.15%, p = 0.007]. In a subpopulation (HbA(1c) > or = 9.0% at baseline, n = 193), patients receiving BIAsp 30 plus metformin had significantly lower HbA(1c) levels at the end of the trial compared with those receiving glibenclamide plus metformin (treatment difference, 0.46 +/- 0.21%, p = 0.027). Mean body weight (+/-s.d) at the end of the trial was significantly lower in patients receiving glibenclamide plus metformin compared with those receiving BIAsp 30 only (84.3 +/- 13.3 kg vs. 88.9 +/- 16.9 kg, p < 0.001). No major hypoglycaemic episodes were recorded during the trial, and incidence rates for minor and symptoms-only hypoglycaemia were low and similar between treatment groups (0.03-0.04 events/patient/week). CONCLUSION: BIAsp 30 added to metformin could be an appropriate therapeutic option for achieving good glycaemic control, compared with the addition of a second oral agent, particularly where HbA(1c) > or = 9%. SN - 1462-8902 UR - https://www.unboundmedicine.com/medline/citation/16367881/Biphasic_insulin_aspart_30_plus_metformin:_an_effective_combination_in_type_2_diabetes_ L2 - https://doi.org/10.1111/j.1463-1326.2005.00492.x DB - PRIME DP - Unbound Medicine ER -