Insulin-based therapy was safe, effective, well accepted and did not cause greater weight gain or hypoglycemia in patients newly diagnosed with type 2 diabetes.

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A new Diabetes Care study evaluated compliance and quality of life with early use of insulin-based therapy after the diagnosis of type 2 diabetes compared with a clinically equivalent treatment regimen of oral antidiabetic agents.

The study included 58 patients aged 21 to 70 years who had been diagnosed with type 2 diabetes within the past two months and were treatment naive. Twenty-nine were randomly assigned to insulin-based treatment and 29 to triple oral therapy with metformin, pioglitazone (Actos, Takeda) and glyburide. Twenty-four of 29 in the insulin treatment group and 21 out of 29 in the triple oral treatment group completed the three-year study.

Compliance was high throughout the study for participants assigned to insulin (93%) as well as those assigned to triple oral therapy (90%).

HbA1c levels improved from 10.8% to 5.9% during the three-month lead-in period — this was maintained during the three-year follow-up period. At study completion, HbA1c levels in the insulin treatment group were 6.1% vs. 6% in the triple oral therapy group (P=.26).

All patients met the American Diabetes Association guideline treatment target at baseline (≤7%); at the end of 36 months, 92% of patients assigned to insulin and 76% of patients assigned to triple oral therapy met the target.

Overall, 55 of 58 participants had at least one episode of hypoglycemia. Hypoglycemic events were similar between groups: 0.51 event per person-month in the insulin group vs. 0.68 event per person-month in the oral group.

When compared with the insulin treatment group, the triple oral therapy group had significantly greater weight gain: 10.10 kg (95% CI, 4.46-15.74) vs. 3.36 kg (95% CI, 0.47-7.20).

“It has been shown previously that an insulin plus metformin regimen is effective and safe as a short-term treatment option to gain rapid glycemic control,” the researchers wrote. “Our data show that long-term continuation of this regimen is equally effective, safe and well accepted by patients compared with a combination of three oral hypoglycemic agents.”

Lingvay I. Diabetes Care. 2009;1789-1795.

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