Most Type 2 patients who are not in good control will eventually require insulin.

Patients who added insulin, either through once-a-day (basal) insulin injections or three injections at mealtimes, to their oral anti-diabetes drugs showed better control of their blood sugar levels than those adding twice daily insulin injections.

Those starting with a single insulin injection each day also had fewer hypoglycemic episodes (when blood sugar levels are too low) and gained less weight.

Professor Rury Holman, principal investigator of the study and director of the Diabetes Trials Unit at Oxford University, UK, stated that, "Type 2 diabetes is a progressive condition with the majority of patients eventually requiring insulin therapy.... This large-scale study strengthens guidelines recommending adding a basal insulin to oral agents when glycemic targets are not met.... As Type 2 diabetes progresses, the standard oral therapy will typically need to be escalated repeatedly over time."

Eventually, the majority of patients will require insulin but there remains uncertainty as to which regimen of insulin injections should be used when oral drugs become insufficient. There is no clear consensus about whether to start with insulin therapy three times a day with meals, injections twice a day, or a long-acting once-a-day insulin injection.

The researchers set out to find which pattern of treatment resulted in the best control of blood sugar levels. Their three-year, randomized controlled trial compared different insulin regimens in 708 patients with Type 2 diabetes whose current doses of anti-diabetic drugs were not proving sufficient.

During the first year, the patients were randomized to one of the three insulin courses. During the second and third years, those who were still not achieving their glucose targets were moved to more complex insulin regimens.

Dr. Jonathan Levy, lead clinician at the Oxford Centre for Diabetes, Endocrinology and Metabolism and co-principal investigator said, "Starting with a basal insulin and adding a mealtime insulin if required provided the best combination of effectiveness, safety and treatment satisfaction."

"These results will help patients and healthcare professionals in routine clinical practice to decide which treatment is most suitable for the individual," added Dr. Andrew Farmer, co-principal investigator at the Department of Primary Health Care.

The University of Oxford research was published in the New England Journal of Medicine, Oct. 2009, to coincide with presentation of the final trial results at the World Diabetes Congress in Montreal, Canada.