Dapagliflozin vs Placebo plus Saxagliptin & Metformin in T2DM
Research type
Research Study
Full title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Therapy with Dapagliflozin added to Saxagliptin in Combination with Metformin compared to Therapy with Placebo added to Saxagliptin in Combination with Metformin in Subjects with Type 2 Diabetes who have Inadequate Glycemic Control on Metformin and Saxagliptin - Protocol: MB102-129
IRAS ID
114095
Contact name
Richard Gaunt
Contact email
Sponsor organisation
Bristol-Myers squibb International Corporation
Eudract number
2011-006324-20
ISRCTN Number
n.a
Clinicaltrials.gov Identifier
n.a
Research summary
Type 2 diabetes develops when the body's ability to make sufficient insulin is impaired; and does not work properly, usually as a consequence of obesity. When this happens glucose builds up in the blood. It is important to appropriately manage type 2 diabetes as poor control can lead to complications such as damage to the eyes, kidneys or nerve endings, as well as cardiovascular events. Treatment starts with diet and exercise but medication is often needed to control diabetes. Metformin is currently the oral drug of choice as first-line therapy. Sometimes metformin alone does not adequately control diabetes so 1 or more types of drugs will be added to the treatment regimen. In this study we aim to compare if dapagliflozin added to metformin and saxagliptin controls diabetes better than metformin and saxagliptin alone. Dapagliflozin is a new type of drug being explored as a diabetic treatment. Saxagliptin is an approved treatment for diabetes. In clinical trials both drugs have shown either moderate weight loss (dapagliflozin) or neutral affect on weight (saxagliptin) and low risk of hypoglycemia (too low blood sugar). The study consists of a 2 week screening period, 8 to 16 week open label treatment period, and 52 week blinded treatment period. Eligible patients will receive saxagliptin plus metformin in the open label period. At the end of this period eligible patients will be randomly assigned to receive either dapagliflozin or placebo in addition to their saxagliptin and metformin. This period is blinded which means neither the patient nor their doctor will know which treatment the patient is taking. Patients will be monitored at frequent visits (every 4 to 8 weeks) in the clinic; routine tests will include physical examinations, vital signs, as well as blood and urine tests to ensure the patient is responding to the medication.
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
12/EE/0481
Date of REC Opinion
28 Nov 2012
REC opinion
Further Information Favourable Opinion