A study showed that Exenatide ( Byetta ) injection lowered blood glucose levels for people with type 2 diabetes who had not achieved target blood glucose levels despite the use of a thiazolidinedione with or without Metformin.

Patients using Exenatide showed improvements in three important measures of blood glucose control: fasting blood glucose, postprandial blood glucose and hemoglobin A1C ( A1C ), which improved by approximately 0.9 percent compared to the control group.
Sixty-two percent of study participants using Exenatide who completed the full study reached target A1C of 7 percent or less.

Exenatide treatment also resulted in a reduction in average body weight.
Exenatide -treated patients lost an average of approximately three pounds of body weight, while those treated with placebo lost on average approximately one- half pound.

A total of 233 patients with elevated A1C in spite of oral diabetes therapy were involved in the randomized, placebo-controlled, parallel, double-blind trial for 16 weeks.
The trial was designed to determine if Exenatide can be used safely and effectively as adjunctive therapy to a thiazolidinedione alone ( about 20 percent ) or with a thiazolidinedione and Metformin ( about 80 percent ), for people with type 2 diabetes.
Study participants were randomized into either of two treatments: the first group received a fixed dose of Exenatide ( 5 micrograms twice-a-day for first four weeks, then 10 micrograms twice-a-day for remainder of study ) in conjunction with a thiazolidinedione, with or without Metformin, and the second group received placebo with a thiazolidinedione, again with or without Metformin.
The average A1C at baseline was 7.9 percent.

Key findings

A1C reduction:

At the end of the study, patients on Exenatide experienced an average reduction in A1C of 0.8 percent from baseline compared to an increase of 0.1 percent in the control group.

Of patients completing the full study, 62 percent treated with Exenatide as a combination therapy achieved an A1C of 7 percent or less, compared to approximately 16 percent in the control group.

Glucose measurements:

Patients treated with Exenatide had average fasting glucose, measured before breakfast, that was 27 mg/dL lower than the control group.

As measured by 7-point glucose monitoring, Exenatide significantly reduced average 2-hour post-meal glucose surges following breakfast and dinner by 34 mg/dL from baseline.

7-point glucose monitoring throughout the day demonstrated a significant reduction in average glucose concentrations in patients receiving Exenatide.

Weight change:

Patients in the Exenatide arm showed an average weight reduction of 3.3 pounds compared with an average weight reduction of 0.4 pounds during treatment in the control arm.

Hypoglycemia:

Rates of mild and moderate hypoglycemia were similar between the Exenatide and placebo treatments. No severe hypoglycemia was reported.

Other adverse events:

The most common adverse event was mild to moderate nausea reported by approximately 40 percent of the patients in the Exenatide group, compared to 15 percent of patients receiving placebo.

Exenatide is the first incretin mimetic, a class of drugs for the treatment of type 2 diabetes. Exenatide exhibits many of the same effects as the human incretin hormone glucagon-like peptide-1 ( GLP-1 ).
GLP-1, secreted in response to food intake, has multiple effects on the intestine, liver, pancreas and brain that work in concert to regulate blood glucose.

Source: Eli Lilly, 2006


XagenaMedicine2006