title: Rosiglitazone: safety and efficacy in combination with insulin in poorly controlled type 2 diabetes mellitus patients treated with insulin alone.
abstract: OBJECTIVE
  To assess the safety and efficacy of rosiglitazone and insulin treatment in combination in poorly controlled insulin-treated type 2 diabetes mellitus (T2DM) patient.
  
  
  METHODS
  In this prospective, open-labelled, nonrandomised study, rosiglitazone was added to the insulin therapy in T2DM patients with baseline HbA1c>or=7.5%. Patients were followed for 12 months. Insulin dosage was adjusted as necessary.
  
  
  RESULTS
  Insulin and rosiglitazone combination was used in 53 patients (29 male, 24 female) for 12 months. Baseline vs. 12-month results shown as mean+/-S.D.: HbA1c reduction 1.53% (9.82+/-1.12 vs. 8.29+/-1.45, P=.0001), insulin dosage reduction 10 U (74+/-34 vs. 64+/-34 U), percentage insulin dose reduction 13.53%, and weight gain 1.0 kg only (84+/-19.93 vs. 85+/-25.73 kg, P=.1). Systolic blood pressure 144+/-22.9 vs. 134+/-15.8 mm Hg (P=.03), total cholesterol 6.18+/-4.15 vs. 4.75+/-2.71 micromol/L, triglyceride 2.62+/-1.49 vs. 2.07+/-1.44 micromol/L, and HDL cholesterol 1.43+/-0.71 vs. 1.63+/-0.36 micromol/L (P=.02). Alanine transaminase actually reduced significantly from 26+/-22 to 19+/-9 IU/L (P=.001). Improved glycaemic control was associated with favourable reduction in cardiovascular risk factors. Rosiglitazone was discontinued only in nine patients (weight gain-4, no improvement noticed-4, ankle swelling-1). No hepatotoxicity was observed.
  
  
  CONCLUSIONS
  Rosiglitazone+insulin combination is safe and effective in inadequately controlled insulin-treated T2DM patients.
authors.affiliation: Diabetes Unit, Blackburn Royal Infirmary, Blackburn, UK. ranjnagarg@yahoo.com
authors.forename: Ranjna
authors.initials: R
authors.lastname: Garg
authors.forename: Jayanthi
authors.initials: J
authors.lastname: Gopal
authors.forename: Geraint Rhys
authors.initials: GR
authors.lastname: Jones
mesh_terms: D000368:Aged; D001786:Blood Glucose / Q000187:drug effects / Q000378:metabolism; D001794:Blood Pressure; D002784:Cholesterol / Q000097:blood; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy* / Q000503:physiopathology; D004359:Drug Therapy, Combination; D006442:Glycated Hemoglobin / Q000187:drug effects / Q000378:metabolism*; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D007328:Insulin / Q000627:therapeutic use*; D008055:Lipids / Q000097:blood; D008875:Middle Aged; D018579:Patient Selection; D000077154:Rosiglitazone; D012449:Safety; D045162:Thiazolidinediones / Q000627:therapeutic use*; D015430:Weight Gain
chemical_list: D001786:Blood Glucose; D002784:Cholesterol; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin; D008055:Lipids; D000077154:Rosiglitazone; D045162:Thiazolidinediones