Less hypoglycemia with insulin glargine in intensive insulin therapy for type 1 diabetes. U.S. Study Group of Insulin Glargine in Type 1 Diabetes.
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- R E Ratner
- MedStar Clinical Research Center, Washington, DC, USA. rratner@compuserve.com
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- I B Hirsch
- MedStar Clinical Research Center, Washington, DC, USA. rratner@compuserve.com
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- J L Neifing
- MedStar Clinical Research Center, Washington, DC, USA. rratner@compuserve.com
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- S K Garg
- MedStar Clinical Research Center, Washington, DC, USA. rratner@compuserve.com
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- T E Mecca
- MedStar Clinical Research Center, Washington, DC, USA. rratner@compuserve.com
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- C A Wilson
- MedStar Clinical Research Center, Washington, DC, USA. rratner@compuserve.com
抄録
<jats:p>OBJECTIVE: Insulin glargine (21A-Gly-30Ba-L-Arg-30Bb-L-Arg-human insulin) is a biosynthetic insulin analog with a prolonged duration of action compared with NPH human insulin. This study compared insulin glargine with NPH human insulin in subjects with type 1 diabetes who had been previously treated with multiple daily injections of NPH insulin and regular insulin. RESEARCH DESIGN AND METHODS: This study was a multicenter randomized parallel-group study in which subjects were randomized to receive premeal regular insulin and either insulin glargine (at bedtime) or NPH insulin (at bedtime for patients on once-daily therapy and at bedtime and in the morning for patients on twice-daily therapy) for up to 28 weeks. Dose titration of both basal insulins was based on capillary fasting whole blood glucose (FBG) levels; the goal was a premeal blood glucose concentration of 4.4-6.7 mmol/l. RESULTS: A total of 534 well-controlled type 1 diabetic subjects (mean GHb 7.7%, mean fasting plasma glucose [FPG] 11.8 mmo/l) were treated. A small decrease in GHb levels was noted with both insulin glargine (-0.16%) and NPH insulin (-0.21%; P > 0.05). Significant reductions in median FPG levels from baseline (-1.67 vs. -0.33 mmol/l with NPH insulin, P = 0.0145) and a trend for a reduction in capillary FBG levels were achieved with insulin glargine. After the 1-month titration phase, significantly fewer subjects receiving insulin glargine experienced symptomatic hypoglycemia (39.9 vs. 49.2%, P = 0.0219) or nocturnal hypoglycemia (18.2 vs. 27.1%, P = 0.0116) with a blood glucose level <2.0 mmol/l compared with subjects receiving NPH insulin. CONCLUSIONS: Lower FPG levels with fewer episodes of hypoglycemia were achieved with insulin glargine compared with once- or twice-daily NPH insulin as part of a basal-bolus regimen in patients with type 1 diabetes.</jats:p>
収録刊行物
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- Diabetes Care
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Diabetes Care 23 (5), 639-643, 2000-05-01
American Diabetes Association
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詳細情報 詳細情報について
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- CRID
- 1361418519762324864
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- NII論文ID
- 30026278489
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- ISSN
- 19355548
- 01495992
- http://id.crossref.org/issn/01495992
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