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Once-Weekly Exenatide Provides Glycemic Control and Weight Loss

Posted: Wednesday, June 17, 2009

Once-weekly exenatide (EQW) produces superior improvements in glucose control and body weight compared with maximum daily doses of sitagliptin and pioglitazone on background metformin, according to study results presented at the American Diabetes Association (ADA) 69th Scientific Sessions.

Results from the Diabetes Therapy Utilization: Researching Changes in A1c, Weight and Other Factors Through Intervention With Exenatide Once Weekly (DURATION)-2 study -- released on June 6 as a late-breaking poster -- also show that exenatide is well tolerated.

In the DURATION-1 study of patients with Type 2 diabetes, EQW (Exenatide Once Weekly) produced a greater improvement in glycemic control than exenatide administered twice daily, with no increased risk of hyperglycemia.

Richard Bergenstal, MD, International compared the efficacy, safety, and tolerability of weekly treatment with EQW (2 mg; n = 160) to maximum daily doses of a dipeptidyl peptidase-4 inhibitor (sitagliptin 100 mg; n = 166) or a thiazolidinedione (pioglitazone 45 mg; n = 165) in patients with Type 2 diabetes on a stable metformin background.

The intent-to-treat population in the phase 3b DURATION-2 study included 491 patients who had received at least one dose of the study medication.

The primary endpoint was the change in glycosylated hemoglobin (HbA1c) from baseline to week 26.

Results at 26 weeks showed that EQW produced a clinically and statistically superior decrease in HbA1c compared with both sitagliptin and pioglitazone (-1.7%, -0.98%, and -1.42% for the 3 groups). The superiority of EQW over sitagliptin was first evident at the sixth week, and EQW's superiority over pioglitazone was first evident at the fourth week.

A significantly higher percentage of EQW patients achieved HbA1c targets of 7.0% or less and 6.5% or less.

EQW also led to significantly more weight loss than sitagliptin from the fourth week throughout the rest of the trial. Pioglitazone-treated patients gained weight (+5.1 kg weight difference vs EQW at week 26).

EQW was the sole treatment associated with significant improvements in systolic blood pressure, brain natriuretic peptide, and albumin/creatinine ratio.

All treatments were generally well tolerated, and over 80% of patients completed the trial. The overall incidence of treatment-emergent adverse events was 71% for EQW, 62% for sitagliptin, and 72% for pioglitazone.

Nausea was transient and predominantly mild, occurring in 24% of EQW patients, 10% of sitagliptin patients, and 5% of pioglitazone patients. There was 1 withdrawal due to nausea in each treatment group, and 1 severe case of nausea in sitagliptin patients.

There was no major hypoglycemia. There were 2 cases of pancreatitis with pioglitazone. No pancreatitis was seen with EQW or sitagliptin.

Overall, the study demonstrates the ability of EQW to produce better glucose and weight than maximum daily doses of sitagliptin and pioglitazone on a background of metformin, Dr. Bergenstal concluded. Notably, EQW was well tolerated, he added.

Source: Diabetes In Control: ADA - [Presentation title: DURATION-2: Exenatide Once Weekly Demonstrated Superior Glycemic Control and Weight Reduction Compared to Sitagliptin or Pioglitazone After 26 Weeks of Treatment. Abstract 6-LB]

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