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Positive results for first phase II study in new class of oral diabetes drugs
Basel | Wednesday, June 9, 2004, 08:00 Hrs  [IST]

A research presented by Novartis pharma showed that the investigational drug, LAF237, the first in its class, improved glycemic control in patients with type 2 diabetes. In this study LAF237, which is administered as a tablet to be taken orally, was added to the standard diabetes treatment metformin in patients whose diabetes was not adequately controlled by metformin alone. Presented at the annual scientific meeting of the American Diabetes Association, the glucose reduction benefits attributed to the addition of LAF237 in this study were sustained for one year.

"LAF237 works completely differently to all other therapies currently used to treat type 2 diabetes," claims Joerg Reinhardt, head of development, Novartis Pharma AG. "This research confirms the potential that Novartis has seen in LAF237, and we believe it could offer a whole new strategy for controlling type 2 diabetes at a time when the disease is reaching epidemic proportions worldwide," he added.

Exploring new diabetes treatments like LAF237 is critically important, especially given the World Health Organization projections that the number of people with diabetes will double to 366 million by 2030. Last year alone, more than 3.2 million deaths were attributed to diabetes or diabetes-related causes.

Researchers studying LAF237 hope to show that the therapy will help to address the underlying imbalance between insulin and glucose production that is the cause of type 2 diabetes. LAF237 works by increasing levels of a specialised incretin hormone called GLP-1by blocking the action of DPP-4, an enzyme that normally inactivates GLP-1. GLP-1 is secreted from the intestine in response to food, and stimulates insulin production by the beta cells of the pancreas. GLP-1 also reduces the secretion of glucagon, a hormone that signals the liver to produce glucose.

Based on the strength of these data and other findings from phase II studies, Novartis launched a full phase III clinical trial programme earlier this year. The completed phase II trial presented was designed to assess the safety and dosing of LAF237 and to make initial efficacy evaluations.

Patients who were part of the metformin plus LAF237 treatment arm sustained an HbA1c level that was an average of 1.1 per cent lower than the group on metformin plus placebo. Glucose levels measured after 8-12 hours of fasting and 1-2 hours after eating a meal were also reduced in patients taking etformin plus LAF237 versus continued therapy with metformin alone. The metformin plus LAF237 group maintained lower HbA1c levels for one year. In contrast, researchers saw an increase in HbA1c in the metformin only group during the same period.

The development of LAF237 is being driven by Novartis' cardiovascular and metabolic drug franchise.

Type 2 diabetes is a condition characterised by blood glucose levels that are too high.

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