Type 2 Diabetes Patients on Technosphere Insulin Exhibited No Adverse Effect
Type 2 Diabetes Treatment
MannKind Corporation (Nasdaq: MNKD) announced on Saturday, September 16, 2006 at the 42nd Annual Meeting of the European Association for the Study of Diabetes (EASD) in Copenhagen results from its Phase 3 clinical study of inhaled insulin in patients with Type 2 diabetes. This study was designed to evaluate whether the MannKind Technosphere(R) Insulin System showed similar safety and efficacy compared to patients treated with insulin aspart (NovoLog(R)), an injected rapid-acting insulin analog (RAA).
"This study demonstrated that patients with Type 2 diabetes using Technosphere(R) Insulin achieved comparable improvements in glycemic control (HbA1c) to patients treated with an injected RAA. In addition, we observed no adverse effect on pulmonary function in either treatment group. However, unlike the injected RAA group, Technosphere(R) Insulin patients lost weight during the treatment period," said Dr. Peter Richardson, Chief Scientific Officer of MannKind.
Alfred Mann, Chairman of the Board and Chief Executive Officer of MannKind, commented, "The results of this first Phase 3 efficacy study show that Technosphere(R) Insulin can be differentiated from other inhaled insulin systems. With the recent completion of enrollment of the major Phase 3 safety study, all of our pivotal Phase 3 trials are now well underway, suggesting that Technosphere(R) Insulin could be the next pulmonary insulin product to reach the market."
The study included 308 patients with Type 2 diabetes who where randomized to the mealtime use of either Technosphere Insulin (n=150) or injected RAA, (n=158), plus insulin glargine as basal insulin.
After a transfer period, patients were followed for 24 weeks during which individual adjustments of therapy were made. Glycemic control in both treatment groups was assessed by periodic determinations of HbA1c levels, which measure the average blood glucose levels during the preceding three to four months. Pulmonary function was assessed by serial measurements of forced expiratory volume (FEV1) and forced vital capacity (FVC). FEV1 is the volume of air that can be forced out in one second after taking a deep breath, and FVC is a measure of pulmonary capacity.
After the treatment period, patients reverted to conventional therapy and pulmonary function was followed for an additional 24 weeks.
Diabetes Study Results
- Both patient groups achieved statistically significant improvements in HbA1c levels (1.05% in the Technosphere(R) Insulin patient group and 1.30% in the injected RAA patient group).
- Pulmonary function did not differ between the two patient groups after six months of treatment and after the six month withdrawal period. These results are consistent with the Company's previous studies on Technosphere(R) Insulin that demonstrated improvement in glycemic control with no effect on lung function.
- Significantly fewer patients experienced hypoglycemia in the Technosphere(R) Insulin patient group than in the comparable injected RAA patient group.
- After six months of treatment, the Technosphere Insulin(R) patient group experienced a weight loss of 0.76 kg compared with the injected RAA patient group, which saw an increase in weight of 0.23 kg (p=0.0007).
- As in previous studies, mild cough was observed in a minority of patients treated with Technosphere(R) Insulin.
According to the United States Centers for Disease Control, or CDC, as of 2005, approximately 20.8 million people in the United States, or 7% of the population, suffered from diabetes. The CDC estimated that 14.6 million cases of diabetes were diagnosed and under treatment and that 1.5 million new cases would be diagnosed in 2005. The CDC reported that diabetes was the sixth leading cause of death listed on death certificates in 2002, but that diabetes was likely to be underreported as a cause of death. Overall, the CDC found that the risk of death among people with diabetes is about twice that of people without diabetes of similar age. The American Diabetes Association estimated that, in 2002, the total cost of diabetes in the United States was $132 billion. This amount includes $12 billion of direct costs for glycemic control treatment, of which approximately $7 billion were for insulin and delivery supplies and approximately $5 billion were for non-insulin oral medications.
Diabetes is a major disease characterized by the body's inability to properly regulate levels of blood glucose, or blood sugar. The cells of the body use glucose as fuel, which is consumed 24 hours a day. Between meals, when glucose is not being supplied from food, the liver releases glucose into the blood to sustain adequate levels. Insulin is a hormone produced by the pancreas that regulates the body's blood glucose levels. Patients with diabetes develop abnormally high levels of glucose, a state known as hyperglycemia, either because they produce insufficient levels of insulin or because they fail to respond adequately to insulin produced by the body. Over time, poorly controlled levels of blood glucose can lead to major complications, including high blood pressure, blindness, amputations, kidney failure, heart attack, stroke and death.