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April 20, 2005

Inhaled Insulin - Promising but Questions Remain

The Guardian reports what could be a press release from a Pharmaceutical company:

Hundreds of thousands of people with diabetes may soon benefit from inhalers that could dramatically cut the number of injections needed to control the disease.

Researchers believe the first insulin inhaler will be licensed for general use in Europe within the year.

The article goes on to reveal:
Trials suggest that for those with type 2 diabetes already on tablets, inhaled insulin gives better blood glucose control than further doses of tablets. For those with type 1 disease, four years of inhaled insulin treatment plus a daily injection have proved effective without serious side-effects.
Insulin inhalers will be of great benefit to those with diabetes once the technology has been developed. One of the problems with this article is it fails to address a fundamental and well known question that should be asked when reporting about insulin inhalers. Specifically, does this inhaler satisfactorily control dosage?

This form of drug delivery is notorious for subject dependent differences and changes through time in the quantity of insulin that is actually absorbed by the body. The reported improvement in treatment of type 2 diabetes does not establish equivalence to injections but simply says it was better than doing nothing. If someone with type 2 diabetes needs insulin will an inhaler be adequate to reduce the likelihood of complications?

The article does suggest that daily usage of inhaled insulin did not have serious side-effects on the lungs, apparently addressing the second major question related to this technology. Absent is a statement of effectiveness related to the use of an inhaler by study participants with Type 1 diabetes. Hmmm ...

Update:

Was I too pessimistic? A kind reader pointed out the following (emphasis mine):

Exubera is a rapid-acting insulin administered by oral inhalation before meals with long-acting insulin administered subcutaneously once or twice daily for type 1 or 2 diabetes mellitus. Exubera provides similar efficacy and improved patient satisfaction compared with standard subcutaneous insulin therapy (ie, NPH twice daily with regular insulin before meals). Efficacy has also been demonstrated for Exubera when used as adjunctive therapy with oral medications for type 2 diabetes. The onset of Exubera is more rapid and its duration of action is similar to that of regular insulin. To date, Exubera administered before meals with a once-daily long-acting subcutaneous insulin (usually Ultralente) has been compared with standard subcutaneous NPH/regular insulin regimens. Comparison of premeal Exubera plus a basal long-acting insulin analog (eg, glargine) with a regimen of premeal subcutaneous rapid-acting insulin analog (eg, lispro or aspart) plus a basal long-acting insulin analog (eg, glargine) is needed to fully evaluate Exubera. Pulmonary safety appears to be maintained for up to 4 years, although there are no data, as of this writing, on the use of this agent in patients with pulmonary conditions. CONCLUSIONS: Exubera is an effective inhaled insulin for preprandial use in type 1 or 2 diabetes. Improved patient satisfaction over injected insulin increases its potential for use earlier in the treatment of type 2 diabetes.

Odegard PS, Capoccia KL., Inhaled Insulin: Exubera, Ann Pharmacother. 2005 Apr 12;


Posted by Diabetologica at April 20, 2005 7:50 AM