Issue 182 Item 10 Inhaled Insulin Combined with Oral Antihyperglycemic Agents Is

Adding inhaled insulin to an oral antihyperglycemic (OHA) treatment regimen can significantly improve glycemic control for patients with type 2 diabetes who are unable to achieve a satisfactory response with OHAs alone.

The efficacy of OHAs can be limited by declining beta cell function, causing many patients with diabetes to experience poor glycemic control despite OHA therapy. However, patients and physicians are often reluctant to start insulin therapy due to a fear that injections may be painful or difficult to administer.

Recent studies have demonstrated that an alternative option, preprandial inhaled insulin (INH), can produce glycemic control responses comparable to that of conventional insulin injections.

Stuart R. Weiss, MD, from the San Diego Endocrine and Medical Clinic, California, United States, and colleagues performed a 3-month proof-of-concept study to examine the effect of additional INH therapy in type 2 diabetes patients failing to achieve good glycemic control with OHA therapy.

Sixty-eight patients on OHA therapy but with poor glycemic control (glycosylated hemoglobin 8.1%-11.9%) were randomized to continue OHA therapy either with the addition of INH therapy (n = 33; mean age, 52.7; 19 males) or with no additional therapy (n = 36; mean age, 49.9; 26 males). For the additional therapy group, 1 or 3 mg INH was administered in 1 to 2 premeal inhalations per day.

After 12 weeks of therapy, patients receiving additional INH showed a much greater improvement in HbA1c levels than those receiving OHAs alone (P < .001). Twenty-one patients (66%) receiving INH+OHA achieved HbA1c levels less than 8%, compared with only 3 patients (8%) receiving OHA alone. Furthermore, 11 patients receiving INH+OHA achieved HbA1c levels less than 7%.

"Inhaled insulin not only resulted in the anticipated reduction in postprandial glucose but also lowered fasting glucose substantially," the researchers noted. Compared with the OHA-only group, the INH+OHA group showed a 60.69 mg/dL greater decrease in fasting plasma glucose (P < .001) and a 26.80 mg h/dL lower increase in 2-hour postprandial glucose (P = .02).

INH therapy was well tolerated with minimal adverse effects. The INH+OHA group experienced a greater change in mean body weight compared with the OHA only group (difference in mean changes, 2.5 kg; P < .001). One incident of severe hypoglycemia occurred with INH+OHA therapy, but the researchers suggest that inhaled insulin, "incurred a risk of hypoglycemia no greater than that expected with combined OHA and SC insulin therapy."

"Although this proof-of-concept study did not include an SC control arm, results demonstrated that the addition of preprandial INH to existing OHAs could improve glycemic control in patients with type 2 diabetes mellitus failing to achieve satisfactory control with OHAs alone," Dr. Weiss concludes.

Arch Intern Med 2003 Oct 27;163:19:2277-82

==============================

"Diabetes in Control 10,000 Step Study 30 Million Steps and 15,000 Miles Later"
Because of the Diabetes In Control Study, more than 12000 patients have started the Step Program.
Have a program for your office.
More Information Then check out www.firststepprogram.com