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Combined therapy with insulin lispro Mix 75/25 plus metformin or insulin glargine plus metformin: a 16-week, randomized, open-label, crossover study in patients with type 2 diabetes beginning insulin therapy.

Abstract

OBJECTIVE

This study aimed to assess glycemic response to a mixture of 75% insulin lispro protamine suspension and 25% insulin lispro (Mix 75/25) BID plus metformin versus insulin glargine QD plus metformin in patients with type 2 diabetes mellitus (DM).

METHODS

Adults new to insulin therapy were enrolled in a multicenter, randomized, prospective, open-label, crossover study with 16 weeks on each treatment. Variables included glycosylated hemoglobin (HbA(1c)), hypoglycemia rate, fasting blood glucose (FBG), 2-hour postprandial blood glucose (ppBG), and rise in blood glucose after meals.

RESULTS

One hundred five patients (mean age, 55 years) were randomized. There was no difference in baseline mean values for either treatment sequence group for body mass index, duration of DM, or HbA(1c). Ninety-five patients completed the study and 67 were included in the efficacy analysis. Mix 75/25 was associated with lower mean (SD) HbA(1c) at end point (7.4% [1.1%] vs 7.8% [1.1%]; P = 0.002). More patients using Mix 75/25 achieved target HbA(1c) < or =7.0% (42% [30/71] vs 18% [13/71]; P < 0.001). With Mix 75/25, the mean (SD) 2-hour ppBG was similar after lunch but lower after breakfast (156.4 [43.6] vs 171.1 [44.9] mg/dL; P = 0.012) and dinner (164.8 [42.5] mg/dL vs 193.8 [51.0] mg/dL; P < 0.001), although FBG was higher (139.3 [36.6] mg/dL vs 123.9 [34.9] mg/dL; P < 0.001). Rise in ppBG was lower with Mix 75/25 after breakfast (16.9 [47.0] mg/dL vs 47.4 [34.8] mg/dL; P < 0.001) and dinner (14.2 [44.1] mg/dL vs 45.9 [41.3] mg/dL; P < 0.001). Gain in mean (SD) body weight was greater with Mix 75/25 than insulin glargine (2.3 [4.0] kg vs 1.6 [4.0] kg; P = 0.006). For all randomized patients, mean (SD) hypoglycemia rates were lower with insulin glargine (0.68 [1.38] vs 0.39 [1.24] episodes/patient per 30 days; P = 0.041), although nocturnal hypoglycemia was similar.

CONCLUSION

In this study population, Mix 75/25 plus metformin was associated with lower HbA(1c) than insulin glargine plus metformin, smaller rise in ppBG after breakfast and dinner, and higher proportion of patients achieving HbA(1c) < or =7.0%, with a slight increase in overall (but not nocturnal) hypoglycemia.

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  • Publisher Full Text
  • Authors+Show Affiliations

    ,

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

    , , , ,

    Source

    Clinical therapeutics 26:12 2004 Dec pg 2034-44

    MeSH

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

    Pub Type(s)

    Clinical Trial
    Journal Article
    Multicenter Study
    Randomized Controlled Trial

    Language

    eng

    PubMed ID

    15823767

    Citation

    Malone, James K., et al. "Combined Therapy With Insulin Lispro Mix 75/25 Plus Metformin or Insulin Glargine Plus Metformin: a 16-week, Randomized, Open-label, Crossover Study in Patients With Type 2 Diabetes Beginning Insulin Therapy." Clinical Therapeutics, vol. 26, no. 12, 2004, pp. 2034-44.
    Malone JK, Kerr LF, Campaigne BN, et al. Combined therapy with insulin lispro Mix 75/25 plus metformin or insulin glargine plus metformin: a 16-week, randomized, open-label, crossover study in patients with type 2 diabetes beginning insulin therapy. Clin Ther. 2004;26(12):2034-44.
    Malone, J. K., Kerr, L. F., Campaigne, B. N., Sachson, R. A., & Holcombe, J. H. (2004). Combined therapy with insulin lispro Mix 75/25 plus metformin or insulin glargine plus metformin: a 16-week, randomized, open-label, crossover study in patients with type 2 diabetes beginning insulin therapy. Clinical Therapeutics, 26(12), pp. 2034-44.
    Malone JK, et al. Combined Therapy With Insulin Lispro Mix 75/25 Plus Metformin or Insulin Glargine Plus Metformin: a 16-week, Randomized, Open-label, Crossover Study in Patients With Type 2 Diabetes Beginning Insulin Therapy. Clin Ther. 2004;26(12):2034-44. PubMed PMID: 15823767.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Combined therapy with insulin lispro Mix 75/25 plus metformin or insulin glargine plus metformin: a 16-week, randomized, open-label, crossover study in patients with type 2 diabetes beginning insulin therapy. AU - Malone,James K, AU - Kerr,Lisa F, AU - Campaigne,Barbara N, AU - Sachson,Richard A, AU - Holcombe,John H, AU - ,, PY - 2004/10/07/accepted PY - 2005/4/13/pubmed PY - 2005/4/29/medline PY - 2005/4/13/entrez SP - 2034 EP - 44 JF - Clinical therapeutics JO - Clin Ther VL - 26 IS - 12 N2 - OBJECTIVE: This study aimed to assess glycemic response to a mixture of 75% insulin lispro protamine suspension and 25% insulin lispro (Mix 75/25) BID plus metformin versus insulin glargine QD plus metformin in patients with type 2 diabetes mellitus (DM). METHODS: Adults new to insulin therapy were enrolled in a multicenter, randomized, prospective, open-label, crossover study with 16 weeks on each treatment. Variables included glycosylated hemoglobin (HbA(1c)), hypoglycemia rate, fasting blood glucose (FBG), 2-hour postprandial blood glucose (ppBG), and rise in blood glucose after meals. RESULTS: One hundred five patients (mean age, 55 years) were randomized. There was no difference in baseline mean values for either treatment sequence group for body mass index, duration of DM, or HbA(1c). Ninety-five patients completed the study and 67 were included in the efficacy analysis. Mix 75/25 was associated with lower mean (SD) HbA(1c) at end point (7.4% [1.1%] vs 7.8% [1.1%]; P = 0.002). More patients using Mix 75/25 achieved target HbA(1c) < or =7.0% (42% [30/71] vs 18% [13/71]; P < 0.001). With Mix 75/25, the mean (SD) 2-hour ppBG was similar after lunch but lower after breakfast (156.4 [43.6] vs 171.1 [44.9] mg/dL; P = 0.012) and dinner (164.8 [42.5] mg/dL vs 193.8 [51.0] mg/dL; P < 0.001), although FBG was higher (139.3 [36.6] mg/dL vs 123.9 [34.9] mg/dL; P < 0.001). Rise in ppBG was lower with Mix 75/25 after breakfast (16.9 [47.0] mg/dL vs 47.4 [34.8] mg/dL; P < 0.001) and dinner (14.2 [44.1] mg/dL vs 45.9 [41.3] mg/dL; P < 0.001). Gain in mean (SD) body weight was greater with Mix 75/25 than insulin glargine (2.3 [4.0] kg vs 1.6 [4.0] kg; P = 0.006). For all randomized patients, mean (SD) hypoglycemia rates were lower with insulin glargine (0.68 [1.38] vs 0.39 [1.24] episodes/patient per 30 days; P = 0.041), although nocturnal hypoglycemia was similar. CONCLUSION: In this study population, Mix 75/25 plus metformin was associated with lower HbA(1c) than insulin glargine plus metformin, smaller rise in ppBG after breakfast and dinner, and higher proportion of patients achieving HbA(1c) < or =7.0%, with a slight increase in overall (but not nocturnal) hypoglycemia. SN - 0149-2918 UR - https://www.unboundmedicine.com/medline/citation/15823767/Combined_therapy_with_insulin_lispro_Mix_75/25_plus_metformin_or_insulin_glargine_plus_metformin:_a_16_week_randomized_open_label_crossover_study_in_patients_with_type_2_diabetes_beginning_insulin_therapy_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0149-2918(04)00085-2 DB - PRIME DP - Unbound Medicine ER -