Clinical studyAddition of pioglitazone or bedtime insulin to maximal doses of sulfonylurea and metformin in type 2 diabetes patients with poor glucose control: a prospective, randomized trial☆
Section snippets
Methods
Eligible patients were recruited from the Vancouver Hospital Diabetes Centre between September 2001 and March 2002. Patients were 30 to 85 years old, had type 2 diabetes for more than 1 year, and were taking maximally tolerated doses of an insulin secretagogue and metformin. All had received diabetes education, were on a diabetic diet, and were performing home blood glucose monitoring. Their most recent HbA1Cmeasurement was >8.0% while undergoing stable diabetes treatment for >12 weeks.
Results
Thirty-one patients were randomly assigned to each treatment arm. One patient was withdrawn from the pioglitazone group after 2 weeks because of noncompliance. In the insulin group, 2 patients voluntarily withdrew after randomization but before starting therapy, and 1 was withdrawn after 2 weeks because of noncompliance. Thirty pioglitazone and 28 insulin patients were left for analysis.
Patients in both treatment groups had similar baseline characteristics (Table 1). All patients were taking
Discussion
Despite evidence that tight glycemic control reduces complications in type 2 diabetes 1, 2, most patients do not have good control (12). One reason may be the progressive nature of type 2 diabetes, which is associated with worsening of metabolic control over time requiring an additional agent every 4 years to maintain optimal control (13). Another explanation is that type 2 diabetes is treated mainly in primary care environments, which are designed to manage acute illnesses rather than chronic
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The study was funded in part by an investigator-initiated grant from Eli Lilly Canada. Eli Lilly had no role in the study design, collection, analysis, or interpretation of the data, or the decision to submit the manuscript for publication. Dr. Thompson has received speaker honoraria from Eli Lilly Canada.