By Jill Stein
ROME -- September 8, 2008 -- Therapy with insulin glulisine with or without oral antidiabetic (OAD) therapy is well tolerated and effective in the treatment of patients with type 2 diabetes who are not optimally controlled with OADs alone, investigators reported here at the European Association for the Study of Diabetes (EASD) 2008.
In a presentation on September 8, JT Woo, MD, Kyung Hee University Medical Centre, Seoul, Korea, described results in 387 Japanese and Korean patients with type 2 diabetes who had been randomised to 16 weeks of treatment with insulin glulisine with an OAD (glulisine + OAD), insulin glulisine monotherapy, or OAD monotherapy.
All patients had been inadequately controlled on a sulfonylurea or sulfonylurea and a biguanide-based regimen.
In the trial, glulisine was titrated to achieve a 2-hour postprandial blood glucose value of 128 to 172 mg/dL using a plasma-referenced blood glucose meter.
In both the glulisine + OAD and OAD monotherapy groups, patients were permitted to continue any prior OAD therapy at a stable dose.
Results showed that glulisine + OAD and glulisine only treatments significantly decreased patients' adjusted mean haemoglobin (Hb) A1C from baseline to endpoint to a larger extent than OAD alone.
Glulisine + OAD and glulisine only were superior to OAD only according to adjusted mean changes in Hb A1C, from a baseline of -1.46% (P < .0001) and -0.64% (P < .0001), respectively.
Hb A1C values decreased steadily throughout the 16-week treatment period in the glulisine + OAD and glulisine only groups, whereas they only decreased over the first 8 weeks in the OAD only group.
Patients who received glulisine + OAD and glulisine alone had greater improvements over time than those receiving OAD alone for Hb A1C, 2-hour postprandial glucose, and blood glucose excursions. The glulisine + OAD group showed a large decrease in fasting plasma glucose from baseline to week 8, which was maintained at the end of the trial.
The number of all symptomatic hypoglycaemia cases per patient-year in the entire treatment phase was 11.9, 8.8, and 1.7 in the glulisine + OAD, glulisine only, and OAD only groups, respectively.
There was 1 case of severe hypoglycaemia, which occurred in the glulisine + OAD group.
The efficacy and safety of insulin glulisine were similar in Japanese and Korean patients.
Overall, the results suggest that glulisine is an effective treatment in Japanese and Korean patients with type 2 diabetics who were not controlled adequately with OAD alone, and additionally show that glulisine represents a valuable treatment option either alone or in combination with OAD for patients who have failed to respond adequately to an OAD alone, Dr. Woo concluded.
He added that the study is the first controlled, clinical trial of glulisine for the treatment of patients with type 2 diabetes who are not adequately controlled by OAD alone in an exclusively Asian population.
Funding for the study was provided by sanofi-aventis.
[Presentation title: Insulin Glulisine Improves Glycemic Control in Type 2 Diabetic Patients Not Optimally Controlled With Oral Antidiabetic Drugs: Results of a Randomized Controlled Study. Abstract 991]
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