| Comparison of insulin lispro protamine suspension and insulin detemir in basal-bolus therapy in patients with Type 1 diabetes. | |
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MedLine Citation:
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PMID: 20536953 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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AIMS: The efficacy of two basal insulins, insulin lispro protamine suspension (ILPS) and insulin detemir, was compared in basal-bolus regimens in Type 1 diabetes. METHODS: In this 32-week, multinational, parallel-group, randomized, controlled trial, adult patients with Type 1 diabetes received ILPS or insulin detemir, injected twice daily (before breakfast and bedtime) and prandial insulin lispro three times daily. The primary outcome was change in glycated haemoglobin (HbA(1c)) from baseline to endpoint. RESULTS: Least squares mean (+/-se) changes in HbA(1c) were similar between groups, meeting non-inferiority (margin, 0.4%): -0.69 +/- 0.07% for ILPS and -0.59 +/- 0.07% for insulin detemir [between-treatment difference -0.10%; 95% confidence interval (CI) -0.29, 0.10]. Standard deviation of fasting blood glucose was similar (non-inferiority margin 0.8 mmol/l): 2.74 +/- 0.14 mmol/l for ILPS and 2.38 +/- 0.14 mmol/l for insulin detemir (CI -0.03, 0.75). Patients on ILPS gained more weight (1.59 +/- 0.23 kg vs. 0.62 +/- 0.24 kg; CI 0.34, 1.60; margin 1.5 kg). Weight-adjusted daily total and prandial insulin doses were lower for ILPS (prandial insulin, 0.38 +/- 0.01 U/kg/day for ILPS, 0.44 +/- 0.01 U/kg/day for insulin detemir; P = 0.004); daily basal insulin dose was similar. All hypoglycaemia incidence and rate and nocturnal hypoglycaemia incidence were similar between groups; nocturnal hypoglycaemia rate was lower for insulin detemir (mean +/- sd 0.79 +/- 1.23 for ILPS, 0.49 +/- 0.85 for insulin detemir; P = 0.001). Severe hypoglycaemia rate was 0.03 +/- 0.11 for ILPS and 0.02 +/- 0.10 for insulin detemir (P = 0.37). CONCLUSIONS: ILPS-treated patients with Type 1 diabetes achieved similar glycaemic control as insulin detemir-treated patients after 32 weeks. Glucose variability was similar. While weight gain and nocturnal hypoglycaemia rate were statistically higher with ILPS, the clinical relevance is unclear. |
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Authors:
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A R Chacra; M Kipnes; L L Ilag; S Sarwat; J Giaconia; J Chan; |
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Publication Detail:
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Type: Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: Diabetic medicine : a journal of the British Diabetic Association Volume: 27 ISSN: 1464-5491 ISO Abbreviation: Diabet. Med. Publication Date: 2010 May |
Date Detail:
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Created Date: 2010-06-11 Completed Date: 2010-11-05 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 8500858 Medline TA: Diabet Med Country: England |
Other Details:
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Languages: eng Pagination: 563-9 Citation Subset: IM |
Affiliation:
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Escola Paulista de Medicina, Federal University of São Paulo, São Paulo, Brazil. |
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| MeSH Terms | |
Descriptor/Qualifier:
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Adult Analysis of Variance Blood Glucose / metabolism Body Weight / drug effects Diabetes Mellitus, Type 1 / blood*, drug therapy* Dose-Response Relationship, Drug Fasting Female Hemoglobin A, Glycosylated / analysis, drug effects* Humans Hypoglycemia / chemically induced Hypoglycemic Agents / administration & dosage, therapeutic use* Injections, Subcutaneous Insulin / administration & dosage, adverse effects, analogs & derivatives* Male Middle Aged |
| Chemical | |
Reg. No./Substance:
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0/Blood Glucose; 0/Hemoglobin A, Glycosylated; 0/Hypoglycemic Agents; 0/basal insulin; 0/insulin detemir; 11061-68-0/Insulin; 133107-64-9/insulin LISPRO |
| Investigator | |
Investigator/Affiliation:
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Alejandra Oviedo / ; Hernan Finkelstein / ; Juan Manuel Corvalan / ; Isaac Sinay / ; Antonio Roberto Chacra / ; Adriana Forti / ; Emmanouil Pagkalos / ; George Piaditis / ; Marian Benroubi / ; Nicolaos Katsilambros / ; Nikolaos Tentolouris / ; Tiberius Mogos / ; Lavinia Pop / ; Adrian Albota / ; Mariana Graur / ; Joel Rodriguez Saldaña / ; Gilberto Mauricio Leguízamo / ; Margarita Barrientos / ; Aniko Somogyi / ; Iren Foldesi / ; Tamas Oroszlan / ; Csaba Ruzsa / ; Zita Birkus / ; Irina Dvoryashina / ; Svetlana Ivanova / ; Sergey Vorobiev / ; Natalia Vorokhobina / ; Irina N Ulianova / ; Vladimir Potemkin / ; Andrew Lowy / ; Robert Moses / ; Richard Simpson / ; John Liljenquist / ; Michael Cox / ; Norman Soler / ; Mark Kipnes / |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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