Type 2 diabetes

Citation

(2009), "Type 2 diabetes", Nutrition & Food Science, Vol. 39 No. 4. https://doi.org/10.1108/nfs.2009.01739dab.015

Type 2 diabetes

Article Type: Food facts From: Nutrition & Food Science, Volume 39, Issue 4

Newly published phase 3 data confirm liraglutide lowers blood sugar and weight in type 2 diabetes patients

Liraglutide treatment leads to greater reductions in HbA1c when added to one oral antidiabetic drug (OAD) compared to adding another OAD, according to two new medical publications. Liraglutide is a human glucagon-like peptide-1 (GLP-1) analog currently in FDA and EMEA review for the treatment of type 2 diabetes.

In a recently published issue of Diabetic Medicine, researchers report that adding liraglutide to glimepiride was more effective at lowering blood sugar than either glimepiride monotherapy or glimepiride/rosiglitazone combination therapy. Patients on liraglutide also experienced increased weight benefit and improved beta-cell function compared to the active rosiglitazone (TZD) comparator treatment.

An additional study published recently in Diabetes Care further supports the efficacy and tolerability profile of liraglutide in the early treatment of type 2 diabetes, this time when added to metformin and compared with glimepiride+metformin combination.

The studies were 26-week, randomised, controlled, double-blind clinical trials involving more than 2,000 patients with type 2 diabetes. The studies are part of the Novo Nordisk LEAD™ clinical 3a programme (Liraglutide Effect and Action in Diabetes). Patients in the studies were randomised to treatment with liraglutide (1.2 mg or 1.8 mg), placebo, or an active comparator, in combination with either glimepiride (a sulfonylurea, or SU, drug) or metformin.

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  Liraglutide added to glimepiride significantly reduced A1c from baseline by 1.08 per cent and 1.13 per cent in liraglutide 1.2 mg and 1.8 mg doses groups, respectively, compared to a reduction of 0.44 per cent in glimepiride+rosiglitazone group.

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  Mean weight benefit of more than 2 kg with liraglutide+glimepiride versus rosiglitazone+glimepiride.

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  Greater improvements in beta-cell function were reported with liraglutide 1.2 mg and 1.8 mg versus rosiglitazone.

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  Liraglutide led to comparable blood sugar (HbA1c) lowering (0.97 per cent, 1.00 per cent and 0.98 per cent in liraglutide 1.2, 1.8, and glimepiride, respectively) when compared to an SU, both in combination with metformin.

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  Weight loss between 1.8 kg and 2.8 kg was reported in patients in the liraglutide arms, versus an increase of 1.0 kg in the SU combination comparator group.

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  Reduced systolic blood pressure was observed in liraglutide 1.2 mg and 1.8 mg groups compared to an increase of 0.4 mmHg in the SU combination group.

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  No major hypoglycaemic events were reported in the liraglutide arms. Minor hypoglycaemia occurred around 6 times more frequently in patients taking glimepiride compared to liraglutide.

About diabetes treatment

Metformin is typically the first OAD treatment to be given to patients with type 2 diabetes whose blood sugar levels cannot be controlled on diet and exercise alone. However, patients who cannot take metformin due to renal impairment or tolerability issues are given an SU such as glimepiride instead.

A recently published American Diabetes Association/European Association for the Study of Diabetes consensus statement on the treatment of type 2 diabetes added GLP-1 agonists as a treatment option when metformin and lifestyle adjustments alone are not sufficient to reach or maintain blood sugar goals.

Safety and tolerability of liraglutide

The most common adverse events in the trials were gastrointestinal in nature (i.e. nausea, diarrhoea and vomiting), and were mostly mild and transient. The rate for minor hypoglycaemia was very low – 0.5 events/patient year or less in these trials. One major hypoglycaemic episode was reported in the LEAD 1 study, but medical assistance was not required.

About liraglutide

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 when 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 USA, as well as a marketing authorisation 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.

For more information, see: novonordisk.com