JANUVIA® (sitagliptin), the first oral type 2 diabetes medication to be made available in Australia in more than seven years, is the result of two decades of research into a completely new way of controlling blood glucose levels. It is the first and only medication in a new class which enhances the body’s natural ability to lower blood glucose (sugar), and is less likely to cause weight gain or low blood glucose levels. JANUVIA is now listed on the Pharmaceutical Benefits Scheme (PBS).
According to Dr Greg Fulcher, Clinical Professor and Director of the Department of Diabetes, Endocrinology and Metabolism at Royal North Shore Hospital in Sydney, the new medication presents a novel approach for treating type 2 diabetes.
"JANUVIA boosts the effect of a natural body process called the incretin system," said Dr Fulcher.
"Incretins are intestinal hormones which are released after food intake, and they are essential for regulating blood glucose. Research has shown that people with type 2 diabetes have an impaired incretin system so their body is unable to lower blood glucose effectively.
“This is the first time we have been able to address an impaired incretin system using an oral medication," Dr Fulcher said. "By increasing the number of intact incretins in the body, JANUVIA helps to control 'on demand' the high blood glucose levels that may contribute to serious long-term health problems such as heart attack, stroke, kidney failure, blindness, nerve damage and amputation."
JANUVIA is taken in combination with other commonly used type 2 diabetes medications (either metformin, a sulfonylurea or a glitazone*).
There are three key triggers of high blood glucose levels in type 2 diabetes – the pancreas can’t make enough insulin, the body becomes resistant to the insulin it makes, and the liver produces too much glucose. JANUVIA lowers blood glucose levels by addressing two of these three key problems.
“It lowers blood glucose by allowing the body to produce more of its own insulin, and it prevents the liver from producing too much glucose. When combined with metformin, the most commonly prescribed treatment for type 2 diabetes, insulin resistance is also addressed," Dr Fulcher said.
The main goal in treating type 2 diabetes is to reduce blood glucose levels to as close to the normal level as possible. In clinical trials of patients with type 2 diabetes whose diabetes was inadequately controlled with metformin alone, more than twice as many patients reached their blood glucose targets when JANUVIA was added.
Currently, two in three people with type 2 diabetes do not achieve adequate blood glucose control.
"Some existing treatments are associated with side effects such as weight gain or causing blood glucose levels to fall too low, and this can affect the ability of patients to achieve adequate blood glucose control," said Professor Tim Davis, Professor of Medicine at the University of Western Australia.
"New treatments that lower blood glucose effectively without causing these difficult side effects will be welcome options for many patients," Prof Davis said.
JANUVIA is less likely to make patients gain weight or cause low blood glucose levels. In clinical trials, JANUVIA was generally weight neutral when compared to placebo‡. The overall incidence of low blood glucose levels (called 'hypoglycaemia') was also similar to placebo. It responds to the presence of blood glucose only when it is needed, thereby lowering the potential for low blood glucose levels.
"JANUVIA is taken once a day, with or without food, which is an important consideration for patients," said Prof Davis. "Many people with type 2 diabetes take multiple medications at different times of the day which can be inconvenient and cause them to miss doses."
The medication is generally well tolerated with an overall incidence of side effects comparable to placebo. The most common side effects reported were stuffy or runny nose, sore throat, upper respiratory infection, or headache.
According to Dr Fulcher, achieving blood glucose control in people living with type 2 diabetes is essential.
“I urge people with type 2 diabetes to ask their doctor about their target blood glucose level and to check that they are managing their disease in the best possible way to prevent the development of serious medical complications.”
Type 2 diabetes is the most common form of diabetes (85-90 per cent of all diabetes cases). It is a progressive disease and often requires additional medications as it grows in severity.
Australia has one of the highest recorded rates of type 2 diabetes in the developed world. Approximately 275 adults in Australia are diagnosed with the disease every day and an estimated 3.4 million Australian adults are expected to have been diagnosed with type 2 diabetes by 2033.
Access Economics estimated that the cost of type 2 diabetes to the Australian community was $11.6 billion in 2005. It is believed that by 2025, more than $302.5 billion will be spent globally on treating and preventing diabetes and its complications.
JANUVIA was listed on the PBS on August 1, 2008 at a cost of $31.30 per month (or $5 for concession/pension card holders). The medication is PBS listed to treat people with type 2 diabetes in combination with either metformin or a sulphonylurea. Patients must meet certain criteria.
More than 8,600 patients participated in the global clinical trial program for JANUVIA, approximately 200 of whom were Australian.
* While JANUVIA is indicated for use with metformin, sulfonylureas or thiazolidinediones, it is only PBS listed for use with metformin or a sulfonylurea.
‡ A placebo is an inactive substance or preparation used as a control in a study to determine the effectiveness of a medicine.
® JANUVIA is a registered trademark of Merck & Co., Inc., Whitehouse Station, N.J., U.S.A
JANUVIA was PBS listed on 1 August 2008 for:
· Dual oral combination therapy with metformin or a sulfonylurea.
· Type 2 diabetes, in combination with metformin or a sulfonylurea, in a patient whose HbA1c is greater than 7% prior to initiation of sitagliptin despite treatment with either metformin or a sulfonylurea and where a combination of metformin and a sulfonylurea is a contraindicated or not tolerated.
The date and level of the qualifying HbA1c must be documented in the patient’s medical records. The date of the HbA1c measurement, which must be no more than 4 months old at the time treatment is initiated, must be provided when the first authority application is made.
PBS Information: Authority required. Refer to PBS Schedule for full authority information
About Merck Sharp & Dohme (Australia) Pty Limited.
Merck Sharp & Dohme is a subsidiary of the global research-based pharmaceutical company Merck & Co., Inc. Beginning operations in 1952, Merck Sharp & Dohme employs approximately 750 people. Since 1995 the Company has brought over 25 innovative new therapies to Australians, including treatments for osteoporosis, high cholesterol, asthma and HIV.
Merck Sharp & Dohme (Australia) Pty Limited. 54-68 Ferndell Street South Granville NSW 2142 Australia.