Rosiglitazone: safety and efficacy in combination with insulin in poorly controlled type 2 diabetes mellitus patients treated with insulin alone

J Diabetes Complications. Jan-Feb 2007;21(1):1-6. doi: 10.1016/j.jdiacomp.2005.10.004.

Abstract

Aims: To assess the safety and efficacy of rosiglitazone and insulin treatment in combination in poorly controlled insulin-treated type 2 diabetes mellitus (T2DM) patient.

Method: 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.

Conclusion: Rosiglitazone+insulin combination is safe and effective in inadequately controlled insulin-treated T2DM patients.

Publication types

  • Controlled Clinical Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Blood Glucose / drug effects
  • Blood Glucose / metabolism
  • Blood Pressure
  • Cholesterol / blood
  • Diabetes Mellitus, Type 2 / drug therapy*
  • Diabetes Mellitus, Type 2 / physiopathology
  • Drug Therapy, Combination
  • Glycated Hemoglobin A / drug effects
  • Glycated Hemoglobin A / metabolism*
  • Humans
  • Hypoglycemic Agents / therapeutic use*
  • Insulin / therapeutic use*
  • Lipids / blood
  • Middle Aged
  • Patient Selection
  • Rosiglitazone
  • Safety
  • Thiazolidinediones / therapeutic use*
  • Weight Gain

Substances

  • Blood Glucose
  • Glycated Hemoglobin A
  • Hypoglycemic Agents
  • Insulin
  • Lipids
  • Thiazolidinediones
  • Rosiglitazone
  • Cholesterol