Sitagliptin is an established diabetes drug medication that acts primarily by stimulating the body’s ability to release insulin, leading to a lowering of blood sugar levels. This clinical trial will examine whether treatment with Sitagliptin can improve both depression and type 2 diabetes together
- Conditions
- Depression in type 2 diabetesMedDRA version: 20.0 Level: PT Classification code 10012378 Term: Depression System Organ Class: 10037175 - Psychiatric disordersMedDRA version: 20.0 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2015-004527-32-GB
- Lead Sponsor
- King's College London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 44
1.A diagnosis of type 2 diabetes according to GP records or clinical guidelines for minimum 6 months
2.Aged 18-75
3.Poor glycaemic control defined as HbA1c 53-86 mmol/mol
4.Already prescribed a first-line anti-diabetes agent (metformin or sulphonylurea) for at least 3 months
5.Current PHQ-9 score =10
6.Fluent in conversational English
7.Able to sign informed consent form
8.Use of contraception if female and of childbearing age. Female participants will require a negative serum pregnancy test before starting the study and will also need to agree to use an acceptable form of contraception throughout the intervention period, e.g. oral contraceptive pill, long-acting reversible contraceptive.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 44
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 44
1. Advanced diabetes complications (registered blind, on dialysis, previous above-knee amputation) or treatment with insulin
2. Pregnancy (tested with serum pregnancy test), planning pregnancy or lactating
3. Severe mental disorders (psychosis, dementia, learning disability, alcohol/substance dependence, active suicidal ideation)
4. Non diabetes-related inflammatory condition or history of pancreatitis
5. Estimated Glomerular Filtration Rate <50ml/minute
6. Morbid obesity (body mass index >40kg/m2)
7. HbA1c >86 mmol/mol
8. Currently prescribed an incretin-based therapy (dipeptidyl peptidase-IV inhibitor or GLP-1 receptor agonist)
9. Currently prescribed an anti-depressant tablet or in receipt of psychological therapy for depression
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: To investigate whether blood sugar control and reduce systemic inflammation are reduced in patients with type 2 diabetes;Primary end point(s): Primary: change in depressive symptoms after 12 weeks as measured by the Patient Health Questionnaire-9 (PHQ-9) and Quick Inventory of Depressive Symptomatology (QIDS-SR-16).;Timepoint(s) of evaluation of this end point: 12 weeks;Main Objective: To investigate whether depressive symptoms improve in patients with type 2 diabetes
- Secondary Outcome Measures
Name Time Method <br> Secondary end point(s): Change in depressive symptoms after 4- and 8 weeks (mid-treatment) and 24 weeks (post-treatment) as measured by Patient Health Questionnaire-9 (PHQ-9) and Quick Inventory of Depressive Symptomatology (QIDS-SR-16).<br> -Change in glycaemic control (fasting glucose, insulin resistance [homeostasis model assessment]), and inflammatory markers (interleukin-4 [IL-4], IL-6, IL-10, C-reactive protein, tumour necrosis factor-a, IL-1ß, IL-1RA, vascular endothelial growth factor, monocyte chemotactic protein-1, white cell count and fasting triglycerides) after 4-, 8- and 12 weeks.<br> -Change in HbA1c from baseline to 12 weeks.<br> ;Timepoint(s) of evaluation of this end point: 4-, 8-, 12-, and 24 weeks after commencement of treatment