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Twice-daily pre-mixed insulin rather than basal insulin therapy alone results in better overall glycaemic control in patients with Type 2 diabetes.

Abstract

AIMS

To compare the glycaemic control of an insulin lispro mixture (25% insulin lispro and 75% NPL) twice daily in combination with metformin to that of once-daily insulin glargine plus metformin in patients with Type 2 diabetes inadequately controlled with intermediate insulin, or insulin plus oral agent(s) combination therapy.

RESEARCH DESIGN AND METHODS

Ninety-seven patients were randomized in a multicentre, open-label, 32-week crossover study. Primary variables evaluated: haemoglobin A1c (A1c), 2-h post-prandial blood glucose (BG), hypoglycaemia rate (episodes/patient/30 days), incidence (% patients experiencing > or = 1 episode) of overall and nocturnal hypoglycaemia.

RESULTS

At endpoint, A1c was lower with the insulin lispro mixture plus metformin compared with glargine plus metformin (7.54% +/- 0.87% vs. 8.14% +/- 1.03%, P < 0.001). Change in A1c from baseline to endpoint was greater with the insulin lispro mixture plus metformin (-1.00% vs. -0.42%; P < 0.001). Two-hour post-prandial BG was lower after morning, midday, and evening meals (P < 0.001) during treatment with the insulin lispro mixture plus metformin. The fasting BG values were lower with glargine plus metformin (P = 0.007). Despite lower BG at 03.00 hours (P < 0.01), patients treated with the insulin lispro mixture plus metformin had a lower rate of nocturnal hypoglycaemia (0.14 +/- 0.49 vs. 0.34 +/- 0.85 episodes/patient/30 days; P = 0.002), although the overall hypoglycaemia rate was not different between treatments (0.61 +/- 1.41 vs. 0.44 +/- 1.07 episodes/patient/30 days; P = 0.477).

CONCLUSION

In patients with Type 2 diabetes and inadequate glucose control while on insulin or insulin and oral agent(s) combination therapy, treatment with a twice-daily insulin lispro mixture plus metformin, which targets both post-prandial and pre-meal BG, provided clinically significant improvements in A1c, significantly reduced post-prandial BG after each meal, and reduced nocturnal hypoglycaemia as compared with once-daily glargine plus metformin, a treatment that targets fasting BG.

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  • Authors+Show Affiliations

    ,

    Lilly Research Laboratories, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285, USA. JKMalone@lilly.com

    , , ,

    Source

    MeSH

    Adult
    Aged
    Blood Glucose
    Circadian Rhythm
    Cross-Over Studies
    Diabetes Mellitus, Type 2
    Drug Administration Schedule
    Drug Delivery Systems
    Drug Therapy, Combination
    Female
    Glycated Hemoglobin A
    Humans
    Hypoglycemia
    Hypoglycemic Agents
    Insulin
    Insulin Glargine
    Insulin Lispro
    Insulin, Long-Acting
    Male
    Metformin
    Middle Aged
    Weight Gain

    Pub Type(s)

    Clinical Trial
    Journal Article
    Multicenter Study
    Randomized Controlled Trial

    Language

    eng

    PubMed ID

    15787659

    Citation

    Malone, J K., et al. "Twice-daily Pre-mixed Insulin Rather Than Basal Insulin Therapy Alone Results in Better Overall Glycaemic Control in Patients With Type 2 Diabetes." Diabetic Medicine : a Journal of the British Diabetic Association, vol. 22, no. 4, 2005, pp. 374-81.
    Malone JK, Bai S, Campaigne BN, et al. Twice-daily pre-mixed insulin rather than basal insulin therapy alone results in better overall glycaemic control in patients with Type 2 diabetes. Diabet Med. 2005;22(4):374-81.
    Malone, J. K., Bai, S., Campaigne, B. N., Reviriego, J., & Augendre-Ferrante, B. (2005). Twice-daily pre-mixed insulin rather than basal insulin therapy alone results in better overall glycaemic control in patients with Type 2 diabetes. Diabetic Medicine : a Journal of the British Diabetic Association, 22(4), pp. 374-81.
    Malone JK, et al. Twice-daily Pre-mixed Insulin Rather Than Basal Insulin Therapy Alone Results in Better Overall Glycaemic Control in Patients With Type 2 Diabetes. Diabet Med. 2005;22(4):374-81. PubMed PMID: 15787659.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Twice-daily pre-mixed insulin rather than basal insulin therapy alone results in better overall glycaemic control in patients with Type 2 diabetes. AU - Malone,J K, AU - Bai,S, AU - Campaigne,B N, AU - Reviriego,J, AU - Augendre-Ferrante,B, PY - 2005/3/25/pubmed PY - 2005/7/6/medline PY - 2005/3/25/entrez SP - 374 EP - 81 JF - Diabetic medicine : a journal of the British Diabetic Association JO - Diabet. Med. VL - 22 IS - 4 N2 - AIMS: To compare the glycaemic control of an insulin lispro mixture (25% insulin lispro and 75% NPL) twice daily in combination with metformin to that of once-daily insulin glargine plus metformin in patients with Type 2 diabetes inadequately controlled with intermediate insulin, or insulin plus oral agent(s) combination therapy. RESEARCH DESIGN AND METHODS: Ninety-seven patients were randomized in a multicentre, open-label, 32-week crossover study. Primary variables evaluated: haemoglobin A1c (A1c), 2-h post-prandial blood glucose (BG), hypoglycaemia rate (episodes/patient/30 days), incidence (% patients experiencing > or = 1 episode) of overall and nocturnal hypoglycaemia. RESULTS: At endpoint, A1c was lower with the insulin lispro mixture plus metformin compared with glargine plus metformin (7.54% +/- 0.87% vs. 8.14% +/- 1.03%, P < 0.001). Change in A1c from baseline to endpoint was greater with the insulin lispro mixture plus metformin (-1.00% vs. -0.42%; P < 0.001). Two-hour post-prandial BG was lower after morning, midday, and evening meals (P < 0.001) during treatment with the insulin lispro mixture plus metformin. The fasting BG values were lower with glargine plus metformin (P = 0.007). Despite lower BG at 03.00 hours (P < 0.01), patients treated with the insulin lispro mixture plus metformin had a lower rate of nocturnal hypoglycaemia (0.14 +/- 0.49 vs. 0.34 +/- 0.85 episodes/patient/30 days; P = 0.002), although the overall hypoglycaemia rate was not different between treatments (0.61 +/- 1.41 vs. 0.44 +/- 1.07 episodes/patient/30 days; P = 0.477). CONCLUSION: In patients with Type 2 diabetes and inadequate glucose control while on insulin or insulin and oral agent(s) combination therapy, treatment with a twice-daily insulin lispro mixture plus metformin, which targets both post-prandial and pre-meal BG, provided clinically significant improvements in A1c, significantly reduced post-prandial BG after each meal, and reduced nocturnal hypoglycaemia as compared with once-daily glargine plus metformin, a treatment that targets fasting BG. SN - 0742-3071 UR - https://www.unboundmedicine.com/medline/citation/15787659/Twice_daily_pre_mixed_insulin_rather_than_basal_insulin_therapy_alone_results_in_better_overall_glycaemic_control_in_patients_with_Type_2_diabetes_ L2 - https://doi.org/10.1111/j.1464-5491.2005.01511.x DB - PRIME DP - Unbound Medicine ER -