Trial of sitagliptin for depressive symptoms in type 2 diabetes
Research type
Research Study
Full title
A pilot randomised controlled trial to assess the efficacy of sitagliptin in reducing depressive symptoms in patients with comorbid type 2 diabetes and depression
IRAS ID
147577
Contact name
Khalida Ismail
Contact email
Sponsor organisation
King's College London
Eudract number
2015-004527-32
Duration of Study in the UK
0 years, 9 months, 26 days
Research summary
One in 5 patients with type 2 diabetes (T2D) has depression. Patients with depression and T2D have more chance of getting complications related to their diabetes (such as stroke and heart attack) and of dying early. However, the reasons for this are not well understood and current treatments for depression do not improve these poor outcomes.
Sitagliptin is an established medication for T2D that acts to reduce blood sugars. In addition, Sitagliptin acts to reduce inflammation – the body’s normal response to infections but which, if elevated for a long time, may worsen both T2D and depression. In a study of 1735 patients with T2D, we recently observed that those receiving Sitagliptin and related medications experienced an improvement in depression. This improvement correlated with reduction in levels of inflammation, suggesting that Sitagliptin may improve depression by reducing inflammation.
We therefore propose a pilot clinical trial of Sitagliptin in 60 patients with T2D and depression. Participants will be recruited from GP surgeries in Lambeth, Southwark, Lewisham and Bromley. Participants will be randomised to receive either Sitagliptin or placebo daily for 12 weeks. Neither participants nor the trial team will know which treatment any patient is receiving. Before starting treatment and every 4 weeks thereafter, participants will answer two depression questionnaires and have blood tests to measure inflammation and blood sugar control. Although treatment will stop after 12 weeks, participants will be seen again after 24 weeks to measure for rebound worsening in depression or HbA1c. Participants will be seen at King’s College Hospital or their own GP surgery. We propose that Sitagliptin will lead significant improvement in depressive symptoms compared to placebo. If successful, this study will provide the first trial evidence that inflammation is important in the depression of T2D and provide the basis for a larger clinical trial.
REC name
London - Dulwich Research Ethics Committee
REC reference
16/LO/1808
Date of REC Opinion
22 Nov 2016
REC opinion
Further Information Favourable Opinion