Protocol

Academic Leadership

TECOS is managed by the Duke Clinical Research Institute and the University of Oxford Diabetes Trial Unit. The TECOS Executive Committee has responsibility for oversight of the trial with the majority of members being independent academics. The Operations Committee, which facilitates trial oversight at the local level, comprises academic investigators.

Sponsor

Merck & Co. Inc. – Whitehouse Station, NJ USA

Study Phase

Phase III

Study Title

A Randomized, Placebo Controlled Clinical Trial to Evaluate Cardiovascular Outcomes after Treatment with Sitagliptin in Patients with Type 2 Diabetes Mellitus and Inadequate Glycemic Control

Study Drug

Sitagliptin is a once daily orally administered dipeptidyl peptidase-IV inhibitor which is used to improve glycemic control in type 2 diabetes mellitus (T2DM). Sitagliptin inhibits the inactivation of the incretin hormones GLP-1 and GIP, which in turn stimulates insulin secretion and suppresses glucagon secretion in a glucose-appropriate manner.

Patient Population

Patients aged 50 years or older with type 2 diabetes and documented vascular disease in the coronary, cerebral, or peripheral arteries, who have inadequate glycemic control (HbA1c of ≥6.5% and ≤8.0%) despite monotherapy or dual combination therapy with metformin, pioglitazone, or a sulfonylurea. We also allow patients receiving a stable dose of insulin, either alone or in combination with a stable dose of metformin, for at least 3 months. Patients have a usual diabetes care provider whom they visit at least twice yearly.

Scope/Study Operations

Global pragmatic trial of approximately 14,000 patients conducted in over 600 experienced clinical sites in Australasia, Asia, Europe, North America, South America, India and South Africa. Streamlined data collection and adverse event reporting. Recruiting sites that have a proven track record for recruiting high numbers of patients as well as sustained enrollment over time and retention of patients for the duration of the trial.

Study Design

Integrated study design with no interruption in usual care. Sitagliptin vs Placebo will be added to the ongoing care regimen. Patients need to be on stable doses of either monotherapy or dual combination therapy with metformin, pioglitazone, or a sulfonylurea i.e. no adjustments to oral antihyperglycemic therapy in the previous 3 months. We also allow patients receiving insulin, either alone or in combination with a stable dose of metformin, but medication must be stable for at least 3 months.

Primary Objective

To compare the impact of adding sitagliptin to usual care vs. usual care without sitagliptin with regard to the risk of developing cardiovascular events.

Patient Follow Up Visits

Streamlined follow up incorporating data collected from usual healthcare practices. Screening/Randomization (performed at same visit), Clinic visits at 4, 8 and 12 months after randomization during the first year, then annual visits interspersed with short office visits every 6 months for approximately 4-5 years. Telephone follow-up will occur commencing at Month 15 and continue every six months thereafter until the completion of the trial.

Site Budget

Trial sites will be paid a fixed per patient fee which will cover study related expenditure including institution overheads and patient related reimbursement. Sites will be paid quarterly based on attended visits and 'clean' data which will be monitored by the Data Co-ordinating Centre. Further details will be provided should your site be eligible to participate in TECOS.

Site Identification

Priority will be given to sites with:

• Prior success in either large cardiovascular or diabetes trials or prior experience in phase III diabetes trials
• Ability to perform screening of large numbers of potential patients
• Ability to manage the trial with minimal requirement for on-site monitoring visits. Initial evaluation of sites will be conducted by telephone. Subsequent on site monitoring will occur twice in the first year and then annually. It is critical that the site PI and identified coordinator have adequate experience in independent trial management.

Study Timelines

Institutional Review Board submissions to begin Quarter 4, 2008
First Patient in December 2008

TECOS Study, Diabetes Trials Unit, OCDEM, Churchill Hospital, Old Road, Headington, Oxford, OX3 7LJ
Tel: +44 (0)1865 857260     Fax: +44 (0)1865 857246     Email: tecos@dtu.ox.ac.uk

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