Janssen has submitted a Marketing Authorisation Application to the EMA for the approval of a fixed-dose therapy which would combine canagliflozin and immediate release metformin for the treatment of type 2 diabetes.

Canagliflozin is an investigational, oral medication for adult patients which blocks the reabsorption of glucose by the kidney, increasing glucose excretion and lowering blood glucose levels.

Metformin is a first-line pharmacotherapy which is used either alone or in combination with other medications, including insulin, to treat type 2 diabetes.

When combined, the fixed-dose therapy may offer adult patients a convenient medication in a single pill.

Janssen submitted a similar application to the US FDA for canagliflozin on 31 May 2012 and for a fixed-dose therapy combining canagliflozin and immediate release metformin on 12 December 2012.

Patients taking both metformin and insulin to help control their type 2 diabetes instead of insulin alone may not benefit from dual therapy, a new study claims.

Researchers from the Copenhagen Trial Unit, Steno Hospital, and the Copenhagen University Hospital agree the combination has a number of positive aspects but questioned the long term benefits for patients.

Authors of the study, published on bmj.com, say that more trials are necessary to provide firm evidence about the effectiveness of the combination, its long term risks and, in particular the risk of premature death.

The study included 2,217 patients over the age of 18 who had type 2 diabetes. It found various examples where levels of HbA1c were reduced with the combination of an oral glucose lowering drug and insulin.

Also, BMI levels and weight gain were also significantly reduced by metformin plus insulin by an average of 1.6kg.

However, a sparse number of important patient outcomes, including mortality from cardiovascular disease and other causes, have led the study’s authors to call for further research on long term risks.

Metformin is currently recommended by guidelines for patients with type 2 diabetes starting on insulin.

Eli Lilly’s Bydureon (exenatide) has been recommended in final guidance in triple or dual therapy regimens as a treatment option for people with type 2 diabetes.

The injection is now available for use on the NHS for patients when their control of blood glucose remains or becomes inadequate in certain circumstances.

Professor Carole Longson, Director, Centre for Health Technology Evaluation at NICE, says that Bydureon has been shown to be a “clinically and cost effective treatment option”.

The convenient prolonged release treatment improves glycaemic control and prevents hyperglycaemia.

In triple therapy regimens in combination with metformin and a sulphonylurea, or metformin and thiazolidinedione, Bydureon is recommended if a person has a certain body mass index (BMI) and has specific psychological or medical problems associated with their weight, or if therapy with insulin would have significant occupational implications or weight loss would benefit other significant obesity-related comorbidities.

Bydureon is also recommended in dual therapy regimens in combination with metformin or a sulphonylurea if either of the two together or separately is contraindicated or not tolerated or treatment with thiazolidinediones and DPP-4 inhibitors is contraindicated or not tolerated.

NICE notes that treatment with the medication for both regimens should only be maintained if a beneficial metabolic response has been demonstrated.

Diabetes UK estimates that around 2.25 million people in the UK now suffer from type 2 diabetes.

Novartis’ Galvus (vildagliptin) has been approved for use by the European Commission for patients with type 2 diabetes who cannot take metformin, the current standard treatment.

The approval is based on data from clinical trials which assessed the drug as a monotherapy and found the treatment delivered improvements in glycaemic control, was generally well-tolerated and associated with a low risk of hypoglycaemia.

David Epstein, Head of Novartis, expects the brand to develop into a “blockbuster, we believe, quite soon”.

Galvus is already approved in the EU as an add-on treatment to metformin, sulphonylureas and thiazolidinediones. Towards the end of 2011, it received approval for patients with type 2 diabetes and moderate or severe renal impairment.

Last year it recorded sales of $677 million, an impressive increase of 66%, despite not being available in the USA. But it is the latest approval which has caused excitement at Novartis. The company estimates that more than 47 million Europeans have type 2 diabetes. It estimates this total will rise to 57 million people by 2030, with a quarter of these people unable to take metformin due to intolerance or contraindications.

NICE has confirmed its recommendation of Eli Lilly’s prolonged release Bydureon (exenatide) for people with type 2 diabetes in final draft guidance.

The guidance recommends the injection as part of triple or dual therapy regimen for patients when their control of blood glucose remains or becomes inadequate in certain circumstances.

Professor Carole Longson, Health Technology Evaluation Centre Director at NICE, says that the estimated 2.25 million people in the UK need as many effective treatments as possible to control the condition.

The injection improves glycaemic control by lowering the rise in blood sugar as a result of eating and prevents hyperglycaemia.

In triple therapy regimens in combination with metformin and a sulphonylurea, or metformin and thiazolidinedione, Bydureon is recommended if a person has a certain body mass index (BMI) and has specific psychological or medical problems associated with their weight, or if therapy with insulin would have significant occupational implications or weight loss would benefit other significant obesity-related comorbidities.

Bydureon is recommended in dual therapy regimens in combination with metformin or a sulphonylurea if either of the two together or separately is contraindicated or not tolerated or treatment with thiazolidinediones and DPP-4 inhibitors is contraindicated or not tolerated.

NICE says that treatment with the injection for both triple and dual therapy regimens should only be continued if a beneficial metabolic response has been proven.

Metformin, sulphonylureas and thiazolidinediones are other treatments used to lower glucose levels in the blood in the management of type 2 diabetes mellitus.