A year long study involving people with early Type 2 diabetes shows that Liraglutide, a new drug similar to Byetta, not only cuts blood sugar, it also helps reduce weight and blood pressure. Analogs of the GLP-1 hormone, Liraglutide and Byetta mimic it by stimulating insulin secretion, including expanding insulin-making beta cells in the pancreas. Likewise, DPP-4 inhibitors, including Januvia – approved in US and Europe and Galvus – approved in Europe but not USA, are a related class of drugs that prevent the degradation of GLP-1 by blocking the enzyme responsible for degrading it.

An improvement of Byetta that require two injections per day, Liraglutide requires once daily injections, even as researchers begin work on its once weekly version of injections.  Yet, to gain approval from the FDA, new study findings ensure it is likely Liraglutide will eventually get approval.

While, both Byetta and Liraglutide cause nausea, vomiting, and diarrhoea, and go away in the first month of treatment, it remains to be seen whether Liraglutide will also cause pancreatitis, the rare though dangerous side-effect of Byetta, though reports indicated two patients on Liraglutide might have been affected. Since, DPP-4 inhibitors play an important role as far as immunity is concerned, a downside in patients taking these drugs, show they are at an increased risk of getting infections.

Alan Garber, MD, Ph.D. of Baylor College of Medicine, who carried out the research, did not compare Liraglutide directly to Byetta or DPP inhibitors.  Instead, during the study it was compared to Amaryl, member of the sulfonylureas class of drugs that stimulate the secretion of insulin.

The 746-patients with early Type 2 diabetes participating in the study, received 1.2-mg or 1.8-mg dose of Liraglutide by injection once each day, or they were given an oral tablet of Amaryl daily.  The patients receiving Liraglutide were given dummy pills; while those on Amaryl received harmless, inactive placebo injections.

Fifty-two weeks of treatment showed that before treatment, the HbA1c scores (a measure of long-term blood-sugar control) ranging from 7% to 11%, dropped considerably after treatment, as under:

1.    HbA1c dropped 1.14% in patients receiving 1.8 mg doses of Liraglutide.
2.    HbA1c dropped 0.84% in patients receiving 1.2-mg doses of Liraglutide.
3.    HbA1c dropped 0.51% in patients receiving Amaryl.
4.    51% of patients getting 1.8-mg doses of Liraglutide reached the American Diabetes Association target HbA1c level of less than 7.0%.
5.    43% of patients getting 1.2-mg doses of Liraglutide reached the ADA target HbA1c level.
6.    28% of patients getting Amaryl reached the ADA target HbA1c level.

It was found that patients on Liraglutide suffering from nausea, lost weight according to the dosage they were receiving i.e. the higher doses of Liraglutide resulted in higher weight loss, while patients on Amaryl put on weight.  As well, Liraglutide worked better at reducing blood pressure than Amaryl.  Only six study participants dropped out because of vomiting and nausea, a common side effect of Liraglutide.

You can read more about the findings in the 25th September 2008 online edition of The Lancet.