How to Use Inhaled Insulin

News from Diabetes Care 2006 6;29(6):1282-7

This was an open-label, multicenter study of people with T2DM with A1cs above 8% who had been treated for 2 months with a maximal dose of a sulfonylurea which was continued at that dose throughout the trial.

Before randomization they were divided into two arms of A1c of 8-9.5% (moderately high) or 9.5-12% (very high). The addition of inhaled insulin demonstrated improved glycemic control as compared to metformin in the “very high” arm but was comparable to adding metformin in the “moderately high” arm and in the overall cohort.

An A1c below 8% was attained by 64% in the inhaled insulin and 58% in the metformin group. 25% of the inhaled insulin and 23% of the metformin group achieved an A1c below 7%. Weight gain was 3 kg with the addition of inhaled insulin with a mean decrease of 0.1 kg with metformin. No statistically significant changes occurred in the lipid parameters in either group.

Hypoglycemia occurred in 114 in the inhaled insulin (73 mild, 36 moderate, and 3 severe) and 54 in the metformin group (41 mild and 12 moderate). The rates of overall hypoglycemia (events/subject-month) were 0.31 for inhaled insulin vs. 0.17 for metformin. Increased cough was reported by 9.0% (20/222) in the inhaled insulin and 1.5% (3/201) in the metformin group. No patients discontinued due to hypoglycemia or cough.

The fact that A1cs improved more with the addition of insulin in the “very high” group is not a surprise. What is surprising is that with an average duration of known diabetes of about 8 years there was so much of a response to the addition of metformin. These data do not suggest that inhaled insulin should replace metformin in our approach to treatment but that perhaps we should consider using it early in people with high A1cs.

I am starting to use it now.

Osteonecrosis of the Jaw

Osteonecrosis of the jaw affects the mandibular bone and the maxillary bone. Other sites reported have been the femoral neck and head, wrist and ear ossicles and know that this is related to "frozen bone" that has prompted concern about the bisphosphonate use in treatment of osteoporosis over the last 5 years.

Many of us have known this as avascular necrosis because certainly that's what it is. A close relationship between this and bisphosphonate therapy has given an increased interest. There have been over 3000 reported cases and over 400 lawsuits have resulted. The Wall Street Journal has focused on jawbones that "rot and die" after IV or oral therapy.

The intravenous use of the bisphosphonate puts people at greatest risk. Although absorption is only a quarter of a percent of Fosamax the half-life being 10 to 12 years makes it is the most dangerous of oral medications. The largest number of lawsuits have directed toward Fosamax.

On August 12, 2006 I had a small meeting of 10 oral surgeons, two oncologists and one endocrinologist to discuss this situation. The transcript of all that was discussed will be out in 10 to 14 days or anyone who would like a copy just send me an e-mail and I will send it to you when it becomes available.