Patients with type 2 diabetes may be able to achieve the same glucose control with fewer injections a day. Two separate studies presented at the American Diabetes Association meeting here found that modern regimens with insulin analogs give similar results with one daily injections versus three or two injections versus four.
The PREFER study compared an intensive basal-bolus insulin regimen using Levemir (insulin detemir) plus NovoLog (insulin aspart) for a total of up to four shots a day to the premixed insulin analog NovoLog Mix 70/30 (biphasic insulin aspart 30) for a total of two injections a day.
"In this study, there is not much difference in basal-bolus insulin and biphasic insulin, which was surprising to us," said Andreas Liebl, M.D., medical director of the Centre for Diabetes and Metabolism in Bad Heilbrunn, Germany. "It is really the same whether you inject twice a day or four times daily."
The 537 patients randomized to receive basal-bolus insulin started with once-daily Levemir either before or after dinner at the patient’s or investigator’s discretion. The Levemir dose was titrated to achieve targets for plasma of 72 to 126 mg/dL before breakfast; the NovoLog dose was titrated to achieve plasma glucose of less than 180 mg/dL after each meal.
All oral antidiabetic agents were discontinued. The 178 patients randomized to premixed insulin analog received it twice daily titrated to achieve plasma glucose levels between 72 and 126 mg/dL before dinner and breakfast. Both groups started out with similar HbA1C (8.52% basal-bolus versus 8.40% premixed) and fasting plasma glucose levels (201.6 mg/dL versus 198.0 mg/dL).
After about six months the mean HbA1C levels dropped by 1.56% in the basal-bolus group and 1.23% in the premixed group. The fasting blood glucose was similarly reduced by 52.9 mg/dL in the basal-bolus group and by 51.8 mg/dL in the premixed group.
While the HbA1C difference was significant between groups, the fasting glucose difference was not. Neither was large enough to be clinically significant, Dr. Liebl said. "In clinical reality there is not much difference." Minor hypoglycemia was similar between groups in both overall and nocturnal events. Major hypoglycemia occurred in 0.9% of basal-bolus group patients compared to 0.0% in the biphasic group.
Dr. Liebl said this was the first study comparing the two types of regimens using modern insulin analogs, which may account for the difference in findings compared with previous studies comparing basal-bolus and non-analog biphasic insulin.
A second study found once-daily basal insulin was comparable to mealtime insulin injections and even gave less hypoglycemia.
"A regimen using the long-acting insulin analog glargine…offers glucose control equivalent to that with the short-acting insulin analog lispro," said Reinhard G. Bretzel, M.D., Ph.D., a professor of medicine at the University of Giessen in Giessen, Germany, and colleagues in the APOLLO study group.
This open-label study randomized 348 patients with type 2 diabetes who had failed oral antidiabetic agents alone to receive these agents plus either once-daily basal Lantus (insulin glargine) or mealtime Humalog (insulin lispro). After 44 weeks of treatment, glucose control was significantly improved in both groups compared to baseline.
Basal and prandial insulin were statistically non-inferior to one another according to the study protocol for HbA1C levels: Lantus reduced the mean HbA1C from 8.71% at baseline to 6.96% while Humalog brought the level down from 8.64% to 6.77%. Fasting glucose control was better with glargine (111 mg/dL versus 145 mg/dL at 44 weeks) as was nocturnal glucose. As expected for prandial insulin, Humalog gave significantly better post-prandial glucose levels.
"However, the glargine regimen was associated with a reduced risk of hypoglycemia, fewer insulin injections and less self-monitoring of blood glucose versus lispro," Dr. Bretzel noted. "Thus, the glargine regimen may improve patient treatment satisfaction and compliance versus the lispro regimen." Hypoglycemic events occurred at a rate of 5.4 per patient year in the Lantus group, which was significantly lower than the 24.4 per patient year in the Humalog group.
Since once-daily therapy in this study was just as good as the three-times daily regimen and the PREFER study showed that twice daily was similar to four-times daily, clinicians may be able to offer their type 2 diabetes patients a more convenient regimen.
"Therapy gets easier," Dr. Liebl said. "We have demonstrated that physicians do have a choice."
· Explain to interested patients with type 2 diabetes that an insulin regimen with fewer daily injections may achieve the same glucose control as one with more daily injections.
· Explain that individual circumstances differ and must be taken into consideration in choosing an insulin regimen.
· These studies were published as abstracts and presented orally at a conference. These data and conclusions should be considered to be preliminary as they have not yet been reviewed and published in a peer-reviewed publication.
2006 American Diabetes Association Scientific Sessions : Liebl A et al. "Biphasic Insulin Aspart 30 (BIAsp30), Insulin Detemir (IDet) and Insulin Aspart (IAsp) Allow Patients with Type 2 Diabetes To Reach A1C Target: The PREFER Study" Presented June 11, 2006 Bretzel RG et al. "Equivalence of Basal Insulin Glargine vs Prandial Insulin Lispro for Glucose Control in Type 2 Diabetes Patients on Oral Agents – Results of the APOLLO Study" Presented June 12, 2006
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