Insulin glargine Vs sitagliptin in patients with type 2 diabetes

• Research type

  Research Study

• Full title

  Superiority study of insulin glargine over sitagliptin in insulin-naive patients with type 2 diabetes treated with metformin and not adequately controlled. - EASIE

• IRAS ID

  4476

• Sponsor organisation

  sanofi-aventis

• Eudract number

  2008-000516-32

• 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 patients with Type 2 diabetes. 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 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 common to start a with long-acting insulin, such as insulin glargine (Lantus©) that intends to control blood glucose levels. 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 for GLP-1 destruction. GLP-1 is able to increase insulin in the body and to decrease the feeling of hunger, therefore controlling diabetes.The purpose of this trial is to assess and compare 2 treatment strategies: injection of insulin glargine or administration of sitagliptin on Hba1c from baseline to the end of treatment. This study is intended for patients with Type 2 diabetes whose blood glucose control remains insufficient despite a treatment with one oral antidiabetic agent (metformin). After patients have consented to take part in the study they will receive either insulin glargine or sitagliptin. Assignment of treatment is performed randomly and the patient??s participation in this study is expected to last up to 6 months after the start of the study treatment.

• REC name

  Wales REC 3

• REC reference

  09/MRE09/7

• Date of REC Opinion

  20 Jan 2009

• REC opinion

  Further Information Favourable Opinion