Drug Helps Lower Blood Sugar
Study: Injectable Drug, Called Byetta, May Lower High Blood Sugar in Patients Taking Other Diabetes Drugs
April 2, 2007 -- The injectable diabetes drug Byetta may lower poorly
controlled blood sugar in patients with type 2 diabetes, a new study shows.
However, the study was "much too small and much too short," states
an editorial published with the study in the Annals of Internal
The study included 233 overweight or obese adults with type 2 diabetes in
the U.S., Canada, and Spain.
When the study started, the patients were already taking the diabetes drugs
Actos or Avandia. Some were also taking the diabetes drug metformin.
However, the patients' blood sugar levels were still too high, according to
hemoglobin A1c tests, which show blood sugar control over the previous six to
Diabetes Drug Study
The researchers included Bernard Zinman, MD, of Mount Sinai Hospital in
Toronto. They randomly split the patients into two groups.
Patients in one group were assigned to give themselves two daily injections
of Byetta for 16 weeks in addition to the diabetes drugs they were already
For comparison, patients in the other group gave themselves two daily
injections of an inactive liquid (placebo) for 16 weeks, in addition to their
other diabetes drugs.
None of the patients knew whether they were giving themselves shots of
Byetta or the placebo.
At the end of the 16-week study, the patients took hemoglobin A1c tests
During the study, the patients taking Byetta lowered their average
hemoglobin A1c level by almost 1 point.
That brought their average hemoglobin A1c level near the upper limit
recommended for people with type 2 diabetes.
The Byetta group also lost about 3 pounds during the study, even though the
researchers hadn't asked patients in either group to diet, exercise, or make
other lifestyle changes.
In comparison, the placebo group didn't improve their average hemoglobin A1c
level and didn't change weight in the study.
Byetta Side Effects
Side effects were more common in the Byetta group. The most common side
effects were mild-to-moderate nausea and vomiting, which affected about 40% of
the patients taking Byetta.
The Byetta group also had a higher percentage of patients who quit the
study. Twenty-nine percent of Byetta patients quit the study, compared with 14%
of those taking the placebo.
Side effects were the main reason for Byetta patients quitting the study,
note the researchers.
Byetta's long-term effects beyond four months aren't addressed in this
The study was designed and funded by Byetta's maker, the drug company Eli
Lilly and Co. Lilly workers were among the researchers. Lilly is a WebMD
The study's small size and short duration leaves many questions unanswered,
notes Saul Malozowski, MD, PhD, MBA, in the journal editorial.
Malozowski works at the National Institute of Diabetes and Digestive and
"Among the most important questions are: Will glucose [blood sugar]
control last more than [four months]? Who is at greatest risk for adverse drug
reactions? Will dose adjustment improve glucose control and decrease adverse
drug reactions?" writes Malozowski.
He notes that when the study started, many patients weren't taking the
maximal dose of Actos, Avandia, or metformin, and that lifestyle change wasn't
part of the study.
"We simple don't know whether patients optimally treated with diabetes
education, diet, TZDs (the group of diabetes drugs that includes Actos and
Avandia), and metformin will receive as much benefit from [Byetta] as the paper
reports," writes Malozowski.