This article is more than 5 years old. Information may no longer be current.
Once-monthly exenatide safe, effective in type 2 diabetes
Click Here to Manage Email Alerts
At all evaluated doses, once-monthly exenatide suspension appears to deliver efficacy and tolerability comparable to that of exenatide once weekly in patients with type 2 diabetes, according to recent findings.
Carol H. Wysham, MD, of the Rockwood Clinic in Spokane, Washington, and colleagues evaluated 121 adults with type 2 diabetes and HbA1c between 7.1% and 11%. The mean age of the patients at baseline was 50 years, the mean fasting HbA1c was 8.5%, mean fasting plasma glucose was 184 mg/dL and mean body weight was 98 kg.
Participants were randomly assigned at a 1:1:1:1 ratio to one of four groups: self-administered subcutaneous exenatide (Bydureon/Byetta, AstraZeneca) 2 mg once per week, caregiver-administered exenatide 5 mg once per month, caregiver-administered exenatide 8 mg once per month or caregiver-administered exenatide 11 mg once per month for 20 weeks. The study primary endpoint was change in HbA1c from baseline to week 20 and secondary endpoints were change in HbA1c by baseline HbA1c gradation (< 9% or 9%), percentage of patients achieving HbA1c goals of less than 7% and changes during the course of 20 weeks in FPG, body weight and seated systolic and diastolic blood pressure.
The researchers found that at week 20, the mean standard deviation decreases in HbA1c were –1.54% with once-weekly exenatide and the mean standard deviations for the once-monthly doses were –1.29% for exenatide 5 mg, –1.31% for exenatide 8 mg and –1.45% for exenatide 11 mg. No significant disparities in HbA1c decreases were seen between the once-monthly suspension doses.
The following decreases in FPG were documented at 20 weeks: –34 mg/dL with the once-weekly dose, –25 mg/dL with the once-monthly 5-mg dose, –30 mg/dL with the once-monthly 8-mg dose and –49 mg/dL with the once-monthly 11-mg dose.
Numerically greater mean standard deviation decreases in HbA1c were seen in patients with baseline HbA1c of 9% or more (–2.28% with the once-weekly dose, –2.37% with the once-monthly 5-mg dose, –2.5% with the once-monthly 8-mg dose and –2.05% with the once-monthly 11-mg dose) compared with participants with baseline HbA1c less than 9% (–1.15% with the once-weekly dose, –0.72% with the once-monthly 5-mg dose, –0.41% with the once-monthly 8-mg dose and –1.2% with the once-monthly 11-mg dose).
Compared with the once-weekly dose, the exenatide once-monthly dose groups had comparable or numerically greater percentages of patients who achieved HbA1c less than 7%, with 48% of participants in the once-weekly group achieving this target compared with 50% in the 5-mg once-monthly group, 57% in the 8-mg once-monthly group and 70% in the 11-mg once-monthly group.
Small BP reductions were achieved in the exenatide once-weekly group and the once-monthly dose groups demonstrated small inconsistent changes not associated with dose. All treatment regimens resulted in weight loss.
“All three doses of the exenatide once-monthly suspension resulted in steady-state exenatide concentrations previously demonstrated to improve glycemic control, with resulting efficacy and tolerability profiles that appeared consistent with those observed with exenatide weekly,” the researchers wrote. “The results of this study combined with [pharmacokinetic] and pharmacodynamics modeling could inform the dose selection for further development.” – by Jennifer Byrne
Disclosure: Wysham reports being a speaker and/or adviser for AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, Janssen, Novo Nordisk and Sanofi. Please see the full study for a list of all other authors’ relevant financial disclosures.
Click Here to Manage Email Alerts