Phase 3 Study to Evaluate Cardiovascular Outcomes of TAK-875 (306)

• Research type

  Research Study

• Full title

  A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate Cardiovascular Outcomes of TAK-875, 50 mg in Addition to Standard of Care in Subjects with Type 2 Diabetes and with Cardiovascular Disease or Multiple Risk Factors for Cardiovascular Events

• IRAS ID

  108477

• Contact name

  Bijayeswar Vaidya

• Sponsor organisation

  Takeda Global Research & Development Centre (Europe) Ltd.

• Eudract number

  2011-001732-37

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Type 2 diabetes mellitus (T2DM) has increased dramatically throughout the world over the past decades despite the availability of several different treatment options. Current pharmacologic treatments include insulin, thiazolidinediones, sulfonylureas, metformin, dipeptidyl-peptidase-4 (DPP-4) inhibitors, and glucagon-like peptide-1 (GLP-1) mimetics. A number of these treatments are associated with clinically important side effects such as low blood sugar (hypoglycemia), weight gainflud retention, exaggeration of pre-existent heart failure, and gastrointestinal side effects. These side effects and the disadvantages associated with many of the currently available antidiabetic agents can reduce compliance and limit their long-term use. Insulin is a hormone that is produced by the body to regulate blood sugar (glucose). In individuals with T2DM, the insulin produced by the body does not effectively control the amount of sugar in the bloodstream. If not properly managed, T2DM may cause elevated blood sugar levels (hyperglycemia) and ultimately result in serious health problems. In response to this problem, Takeda is developing TAK-875 (an investigational drug) as an addition to diet and exercise to improve blood sugar control in patients with T2DM. TAK-875 may affect the production of insulin and may improve how the body uses the sugar in the blood. Cardiovascular (CV) safety is of special interest in people with T2DM who have CV disease or who are at high risk from it. The aim of this study is to find out it taking TAK-875 plus Standard of Care (SOC) diabetic medication is better than taking placebo plus SOC diabetic medication in people with T2DM at risk for CV disease. Approximately 5000 patients worldwide aged 18 or over with T2DM and risk factors for CV events, will take part in this study and will be involved in the study for up to 6 years including up to 23 visits to the study centre.

• REC name

  South Central - Oxford C Research Ethics Committee

• REC reference

  12/SC/0504

• Date of REC Opinion

  17 Dec 2012

• REC opinion

  Further Information Favourable Opinion