1. Inhaled Human Insulin Treatment in Patients with Type 2 Diabetes Mellitus Matthew Faiman

2. Background Conventional Insulin therapy relies on daily injections Intensive insulin therapy relies on multiple, frequent insulin injections BUT….. multiple injections are inconvenient poorly approximates endogenous insulin secretion requires time, effort, communication and commitment

3. Alternate means of insulin are now underway humalog insulin pumps inhaled insulin Inhaled Insulin pulmonary delivery includes a powder insulin along with an aerosol delivery system

4. METHODS Inclusion Criteria patients age 35-65 100%- 175% of IBW were on stable insulin schedule (2-3 injections) Hb A1c levels of 7%- 11.9% fasting C-peptide concentrations 0.2 pmol/ml or greater normal CXR normal PFTs

5. METHODS Exclusion Criteria serum creatinine > or = to 3.0 mg/dl major organ system disease, except HTN and end- organ disease (neuropathy and retinopathy) smoking insulin pump 4 or more injections of insulin more than 150 units of insulin daily concomitant oral hypoglycemic

6. STUDY DESIGN patients receiving inhaled insulin were given ultra- lente insulin at bedtime Inhaled insulin was administered qac administered as 1 to 2 inhalations pharmacokinetics approximated 1 mg inhaled to be equivalent to 3 units of SC insulin dose titrated to glucose response ? Single unit adjustments…. eg 0.5 mg inhaled insulin

7. STUDY DESIGN blood glucose measured prior to insulin if target range (100-160 mg/dl) exceeded then adjustment made to hs ultra-lente dose Hypoglycemia determined by symptoms and by BG less than 50-60

8. Clinical Variables PFTs- FEV1, FVC, PEF, lung volumes, DLCO and oximetry Hb A1c

9. STASTICAL ANALYSIS assessed by 12 week change in Hb A1c level from baseline 95% Confidence Intervals for mean of the change calculated used Standard Error (SE) SE = SD/square root of sample size N Student’s t-test data presented as mean +/- SD

10. RESULTS N= 26 participants 16 were men with avg. BMI 30 10 women with avg BMI 33 Avg age 51.1 yrs (39-64) Avg duration of diabetes 11.2 yrs (0.9-35) Inhaled insulin improved glycemic control

11. RESULTS Hb A1c decreased from 8.67% +/- 1.44% baseline to 7.96% +/- 1.37% by 12 weeks change was -0.71% +/- 0.72% C.I. -1.00% to -0.42% 18 patients (69%) experienced mild-mod hypoglycemic episodes. No severe episodes noted average of 0.83 episodes per month

12. RESULTS No significant change from baseline in post prandial BG levels (240+/- 56 mg/dl) at baseline vs. 241+/- 57 mg/dl no significant weight gain delta -0.3 +/- 2.9kg No significant change from baseline spirometry, Lung volumes, DLCO or oximetry