People with type 2 diabetes may find that a new GLP-1 drug being tested in clinical trials may help to control both their blood sugar and their high blood pressure.
A large study was presented last week at the 27th American Society of Hypertension Scientific Meeting by Tulane University School of Medicine researchers. Led by Dr. Keith C. Ferdinand, the researchers found that the drug, dulaglutide being developed by Eli Lilly, lowered blood pressure by a significant amount compared to a placebo. (Published site)
“Dulaglutide is currently in Phase III clinical trials, where it will continue to be evaluated on its efficacy to lower blood glucose levels, overall safety, weight effects and effects on cardiovascular outcomes,” said Gwen Krivi, Ph.D., vice president, product development, Lilly Diabetes. “We believe dulaglutide, if approved, can bring significant benefits to people with type 2 diabetes.”
Dulaglutide is a GLP-1 blocker, similar to Victoza and Bydureon. Like those two, dulaglutide is a once-weekly injection that works by stimulating the beta cells to release insulin only when blood sugar levels are high. The study results were announced in a Lilly press release.
In the study 755 adult patients averaging 56 years old were treated at 76 centers in seven countries. All patients had type 2 diabetes, with HbA1c level of 7 percent to 9.5 percent and were on a stable regimen of at least one oral blood sugar-lowering medication. Two-thirds of the 755 had a pre-existing diagnosis of high blood pressure, and to participate they had to be taking no more than three medications to lower their blood pressure.
The patients were randomly assigned to one of three treatment groups, one received dulaglutide at a dose of .75 mg, one group received dulaglutide at a dose of 1.5 mg, and the third group received a placebo.
The main objective of the study was to see the effect of the drug on blood pressure. After 16 weeks they found that the drug at the .75 mg dose lowered blood pressure by an average of 1.07 mm Hg at 16 weeks, which was not considered to be statistically significant, meaning the difference was so small they could not rule out the possibility that the reduction was due to chance.
At the higher 1.5 mg dose, however, patients lowered their blood pressure by an average of 2.8 mm Hg, which was a statistically significant amount. The difference remained after 26 weeks.
Both doses of dulaglutide produced a significant reduction in blood sugar levels compared to placebo at both 16-weeks and 26-weeks. The lower dose produced a nonsignificant increase in average heart rate of 1.6 beats per minute, while the bigger dose produced a significant average increase in heart rate of 2.84 beats per minute.
Side effects reported included diarrhea, nausea and vomiting, which is similar to other GLP-1 agonist drugs.
Four of the authors of the study work for Eli Lilly, and lead author Ferdinand disclosed relationships with AstraZeneca, Novartis, Pfizer, Forest, Daiichi-Sankyo, and Takeda.
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