Phase 3b Study of saxagliptin with insulin in Type 2 Diabetes, v.1
Research type
Research Study
Full title
CV181-057 - A multicentre, randomized, double-blind, Phase 3b trial to evaluate the efficacy and safety of saxagliptin added to Insulin Monotherapy or to Insulin in combination with Metformin in subjects with Type 2 Diabetes who have inadequate glycemic control on Insulin alone or on Insulin in combination with Metformin
IRAS ID
4676
Contact name
Rudolf Bilous
Sponsor organisation
Bristol-Myers Squibb International Corporation
Eudract number
2008-001089-10
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
Research summary
There are two million people in the UK with Type 2 diabetes. Type 2 diabetes may lead to damage to the eyes, the kidneys or the nerve endings leading to risk of amputation. It is also associated with cardiovascular events such as heart attack or stroke. Treatment to reduce blood sugar levels minimises the risk of developing these complications. Currently available treatments may cause low blood sugar, weight gain and swelling without adequately reducing blood sugar levels. The study will measure the effect of the study drug saxagliptin on decreasing high blood sugar levels. Patients with Type 2 diabetes currently treated with insulin or insulin in combination with Metformin with poorly controlled blood sugar levels will receive either saxagliptin or placebo (dummy drug) in addition to their current treatment. The aim of this study is to show that the decrease in blood sugar levels will be greater in those treated with saxagliptin in addition to current treatment to those receiving placebo in addition to current treatment.435 patients who consent to take part in this 56 week study will receive either saxagliptin or placebo (two patients to saxagliptin for every one to placebo); will record their daily self blood glucose (finger prick test), their daily treatment doses and maintain diet and exercise management. They will also undergo physical examination, blood, urine, and heart function tests at study visits. The study will comprise a screening period, a short term treatment phase of 24 weeks and a long term treatment phase of a further 28 weeks. Patients will attend a maximum of 15 study visits. A rescue procedure will be followed for any patient with increased blood sugar levels. The research will be funded by Bristol-Myers Squibb and patients will be recruited in the UK from hospitals in England and Wales.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
08/H1306/170
Date of REC Opinion
27 Mar 2009
REC opinion
Further Information Favourable Opinion