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Head-to-Head Phase 3 Trial of Exenatide and Liraglutide

In a head to head trial (LEAD 6), it showed that liraglutide, a human GLP-1 analog administered once daily was significantly more effective at improving blood glucose control (as measured by HbA1c) than exenatide, a GLP-1 mimetic administered twice daily.

In this study, reduction in blood glucose was greater with liraglutide than with exenatide,” said Lawrence Blonde, MD, Director of the Ochsner Diabetes Clinical Research Unit in the Department of Endocrinology, Diabetes, and Metabolism at the Oxford Center in New Orleans. “Patients treated with once-daily liraglutide achieved better blood glucose control and also had less minor hypoglycemia than those treated with exenatide.”

Fasting plasma glucose was also reduced significantly more with liraglutide compared to exenatide. Furthermore, liraglutide was also associated with higher HOMA-B values, an assessment of beta-cell function.

The 26-week study included 464 people with type 2 diabetes who were randomized to treatment with either liraglutide 1.8 mg once daily or exenatide 10 micrograms twice daily, both as an add-on to their existing treatment consisting of metformin and/or a sulphonylurea.

The overall rate of hypoglycemia in the study was low. Liraglutide patients experienced significantly less minor hypoglycemia compared to those on exenatide.

Nausea was the most common side effect for both treatments and was reported at a level of 25.5% in the liraglutide group and 28% in exenatide group (percent of all study participants reporting nausea at least once). However, in the liraglutide group, the percentage of patients reporting nausea in each week fell to 8% after 5 weeks, 4% after 10 weeks and 3% after 26 weeks. In the exenatide group, reports of nausea fell to 13% after 8-10 weeks of treatment and remained above 10% for more than 20 weeks.

Other common gastrointestinal-related adverse events with liraglutide were diarrhea, vomiting and dyspepsia.

Patients on both treatments lost weidht during the study. Weight reduction in patients on liraglutide was also consistently seen in the LEAD(TM) 3a studies.

Once-daily liraglutide is the first human glucagon-like peptide-1 (GLP-1) analogue developed for the treatment of type 2 diabetes. Liraglutide works by stimulating the release of insulin and inhibiting the release of glucagon from the liver after meals only if blood sugar levels are elevated. Weight loss with liraglutide is attributed to the fact that it slows gastric emptying and leads to increased satiety after meals. Liraglutide is naturally broken down in the body and does not require renal excretion.

On 23 May 2008, Novo Nordisk submitted a New Drug Application to the Food and Drug Administration in the United States, as well as a marketing authorization application to the European Medicines Agency in Europe, for the approval of liraglutide for the treatment of people with type 2 diabetes. A New Drug Application was also submitted for approval in Japan on 14 July 2008.

L Blonde, J Rosenstock, G Sesti et al. Liraglutide: Superior Glycemic Control versus Exenatide When Added to Metformin and/or Sulphonylurea in Type 2 Diabetes (LEAD-6). Poster presented at the Canadian Diabetes Association Congress, 15-18 October 2008, Montreal, Canada.
Garber A et al. Lancet 2008; DOI:10.1016/S0140-6736(08)61246-5.
Zinman B et al. Diabetologia 2008; 51 (Suppl 1):S359. 6. Russell-Jones D et al. Diabetes 2008; 57 (Suppl 1):A159.

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