glargine clinical trial

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Introduction

1

European study, 371 patients, mean HgbA1c 8.8%

glargine + oral hypoglycemic agents* vs insulin 70/30 BID alone

mean decrease in HgbA1c at 24 weeks 1.6% vs 1.3% in favor of glargine group

hypoglycemia less frequent in glargine group not blinded, results favored sponsors of study

* metformin + glimepiride

2.

US study, 233 patients, mean HgbA1c 9.7%

glargine QHS vs insulin 70/30 BID

mean decrease in HgbA1c at 24 weeks 2.8% vs 2.4% in favor of insulin 70/30 group

all patients continued oral hypoglycemic agent(s)* not blinded, results favored sponsor of study

* metformin (all patients) + pioglitazone (1/3 of patients)

More general terms

References

  1. Journal Watch 25(7):53-54, 2005
    Janka HU, Plewe G, Riddle MC, Kliebe-Frisch C, Schweitzer MA, Yki-Jarvinen H. Comparison of basal insulin added to oral agents versus twice- daily premixed insulin as initial insulin therapy for type 2 diabetes. Diabetes Care. 2005 Feb;28(2):254-9. PMID: https://www.ncbi.nlm.nih.gov/pubmed/15677775
    Raskin P, Allen E, Hollander P, Lewin A, Gabbay RA, Hu P, Bode B, Garber A; INITIATE Study Group. Initiating insulin therapy in type 2 Diabetes: a comparison of biphasic and basal insulin analogs. Diabetes Care. 2005 Feb;28(2):260-5. PMID: https://www.ncbi.nlm.nih.gov/pubmed/15677776
    Davidson MB. Starting insulin therapy in type 2 diabetic patients: does it really matter how? Diabetes Care. 2005 Feb;28(2):494-5. No abstract available. PMID: https://www.ncbi.nlm.nih.gov/pubmed/15677824