Combination therapy of insulin glargine and sitagliptin.

• Research type

  Research Study

• Full title

  Combination therapy of insulin glargine and sitagliptin in patients with type 2 diabetes not adequately controlled by a previous treatment with metformin and either insulin glargine and or sitagliptin. EASIE extension study.

• IRAS ID

  5709

• Contact name

  David Owens

• Sponsor organisation

  sanofi-aventis

• Eudract number

  2008-000521-19

• ISRCTN Number

  0000000000000

• Clinicaltrials.gov Identifier

  0000000000000

• Research summary

  Approximately 151 million people in the world (more than one million diagnosed in the UK) are affected by diabetes, 75% of these being Type 2 diabetics. In type 2 diabetes the body does not make enough insulin or cannot use insulin properly. Insulin helps to transfer glucose from the blood into the cells of the body where it is used as fuel. People with type 2 diabetes can therefore have higher than normal levels of glucose in their blood. In the long term, failure to control glucose levels can lead to serious health issues including cardiovascular disease, kidney problems, eye and nerve damage, ulcers and death of tissue which may lead to amputation. Management of diabetes therefore targets control of blood glucose to minimize these long term risks. Diabetes care is complex and requires strict glycaemic control. Many types of diabetic pills can help manage type 2 diabetes, in combination with diet and regular physical activity. Over the course of time the effectiveness of these tablets and lifestyle changes may decrease and eventually most patients will need insulin injections to maintain optimal blood glucose levels. Insulin treatment should start as soon as one or more oral antidiabetic agents are no longer effective in order to achieve optimal control. In medical practice, it is usual to start a with long-acting insulin, such as insulin glargine (Lantus© New drugs are being developed to treat diabetes, in particular new pills such as sitagliptin. Sitagliptin works differently in the body compared to other available treatments. It works by blocking a natural enzyme (which exists in the body), responsible of the GLP-1 destruction. GLP-1 is able to increase insulin in the body and to decrease the feeling of hunger, therefore controlling diabetes. This study is intended for type 2 diabetic patients whose blood glucose control remains insufficient despite treatment in the core study with insulin glargine metformin or sitagliptin metformin. The mechanism of action, as well as the target of insulin glargine and sitagliptin are different and it can be expected that both drugs have additive effects on blood glucose control. Their co-administration with metformin in this study will address the question of the added value of these 3 drugs in patients not adequately controlled.

• REC name

  Wales REC 3

• REC reference

  09/MRE09/36

• Date of REC Opinion

  20 Aug 2009

• REC opinion

  Further Information Favourable Opinion