Efficacy and Safety of Exubera Insulin Versus Injectable Insulin

The efficacy and safety of human insulin inhalation powder (HIIP) plus insulin glargine were compared to subcutaneously injected insulin (SC insulin) plus insulin glargine in patients with type 1 diabetes.

This was a randomized, open-label crossover study in which one group of patients received preprandial HIIP plus insulin glargine for 12 weeks, followed by the same duration with preprandial SC insulin (lispro or regular) plus insulin glargine. Another group of patients received the reverse treatment sequence.

The trial was designed as a non-inferiority comparison of the two treatments for effect on HbA(1c); blood glucose levels were also monitored. Safety assessments included adverse event reporting and hypoglycemic events.

The results showed that HbA(1c) at endpoint was 7.95+/-0.12% for the HIIP treatment and 8.06+/-0.12% for the SC insulin treatment; mean changes from baseline to endpoint were -0.08 and 0.00%, respectively, (p=NS). The upper limit of the 95% CI of mean difference in HbA(1c) between the two treatments was 0.02%, indicating that HIIP was not inferior relative to SC insulin, as measured against the pre-defined margin of 0.3%.

Fasting blood glucose was significantly lower for HIIP treatment (8.09+/-0.33 mmol/l; n=117) than for SC insulin treatment (9.05+/-0.33 mmol/l; n=111) (p=0.01).

Safety profiles were comparable between the two treatments. The rate of any hypoglycemia was 8.9+/-0.7 and 8.2+/-0.8 for HIIP and SC insulin treatments, respectively, (p=0.29). The rate of nocturnal hypoglycemia was greater for HIIP (4.2+/-0.4) than for SC insulin (2.7+/-0.4; p<0.001).

From the results it was concluded that HIIP was similar in efficacy to SC insulin for glycemic control in type 1 diabetes mellitus. The two treatments had comparable safety profiles.

Diabetologia. 2006 May;49(5):891-9. Epub 2006 Feb 28.

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DID YOU KNOW:
Race Influences Side Effects of Cardiovascular Drugs: Compared with patients of other ethnicities, black and East Asian patients are at increased risk for various adverse reactions when taking cardiovascular drugs, Ethnic group "may be one determinant of harms of a given treatment in the individual patient, either because it acts as a surrogate measure of genetic make up or because cultural factors alter the risk," senior author Dr. Robin E. Ferner and colleagues note. From a meta-analysis of data from 24 studies it was found that, black patients taking ACE inhibitors were three times more likely to develop angioedema than their non-black counterparts. In addition, black ethnicity raised the risk of intracranial hemorrhage from thrombolytic therapy by 50%.East Asian patients were also at heightened risk for side effects when taking cardiovascular drugs. In particular, they were 2.7-times more likely to experience cough with ACE inhibitor therapy than were white patients. May 4th online issue of the British Medical Journal.

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