title: Metformin for obese, insulin-treated diabetic patients: improvement in glycaemic control and reduction of metabolic risk factors.
abstract: The efficacy and safety of metformin in the treatment of obese, non-insulin-dependent, diabetic subjects poorly controlled by insulin after secondary failure to respond to sulphonylureas has been investigated. Fifty insulin-treated, obese diabetics participated in this prospective, randomised double-blind six-month trial. After a four-week run-in period, during which all patients were given placebo (single-blind), patients were randomly assigned to continue to receive placebo or to active treatment with metformin. At six months, there was a relevant and significant improvement in glycaemic control in diabetics receiving the combined insulin-metformin treatment (decrease in glucose -4.1 mmol.l-1; glycosylated haemoglobin A1 decrease -1.84%). No significant changes were seen in diabetics receiving insulin and placebo. There was a significant decrease in blood lipids (trygliceride and cholesterol), an increase in HDL-cholesterol and a reduction in blood pressure in diabetics taking metformin. These positive findings were most marked in the 14 diabetics who experienced a good response to metformin (glucose profile < 10 mmol.l-1), and were less marked but still significant in the remaining 13 diabetics, whose response to therapy was not so good (glucose profile > 10 mmol.l-1). The fasting insulin level was significantly lower after six months of combined insulin-metformin treatment as shown by a 25% reduction in the daily dose of insulin (-21.6 U/day). Metformin was well tolerated by all diabetics.(ABSTRACT TRUNCATED AT 250 WORDS)
authors.affiliation: Department of Geriatrics and Metabolic Diseases, First Faculty of Medicine, University of Naples, Italy.
authors.forename: D
authors.initials: D
authors.lastname: Giugliano
authors.forename: A
authors.initials: A
authors.lastname: Quatraro
authors.forename: G
authors.initials: G
authors.lastname: Consoli
authors.forename: A
authors.initials: A
authors.lastname: Minei
authors.forename: A
authors.initials: A
authors.lastname: Ceriello
authors.forename: N
authors.initials: N
authors.lastname: De Rosa
authors.forename: F
authors.initials: F
authors.lastname: D'Onofrio
mesh_terms: D001786:Blood Glucose / Q000378:metabolism; D001794:Blood Pressure / Q000187:drug effects; D002096:C-Peptide / Q000097:blood; D003920:Diabetes Mellitus / Q000188:drug therapy* / Q000378:metabolism; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy* / Q000378:metabolism; D004311:Double-Blind Method; D005260:Female; D005934:Glucagon / Q000494:pharmacology; D006442:Glycated Hemoglobin / Q000378:metabolism; D006706:Homeostasis / Q000502:physiology; D006801:Humans; D007515:Islets of Langerhans / Q000187:drug effects / Q000378:metabolism; D008055:Lipids / Q000097:blood; D008297:Male; D008687:Metformin / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D009765:Obesity; D011446:Prospective Studies; D012307:Risk Factors; D016037:Single-Blind Method
chemical_list: D001786:Blood Glucose; D002096:C-Peptide; D005934:Glucagon; D006442:Glycated Hemoglobin; D008055:Lipids; D008687:Metformin