E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Depression in type 2 diabetes |
|
E.1.1.1 | Medical condition in easily understood language |
Depression in type 2 diabetes |
|
E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Mental Disorders [F03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10012378 |
E.1.2 | Term | Depression |
E.1.2 | System Organ Class | 10037175 - Psychiatric disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10067585 |
E.1.2 | Term | Type 2 diabetes mellitus |
E.1.2 | System Organ Class | 10027433 - Metabolism and nutrition disorders |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To investigate whether depressive symptoms improve in patients with type 2 diabetes |
|
E.2.2 | Secondary objectives of the trial |
To investigate whether blood sugar control and reduce systemic inflammation are reduced in patients with type 2 diabetes |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
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.
|
|
E.4 | Principal exclusion criteria |
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
|
|
E.5 End points |
E.5.1 | 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). |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | 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). -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-α, IL-1β, IL-1RA, vascular endothelial growth factor, monocyte chemotactic protein-1, white cell count and fasting triglycerides) after 4-, 8- and 12 weeks. -Change in HbA1c from baseline to 12 weeks.
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
4-, 8-, 12-, and 24 weeks after commencement of treatment |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
The end of the trial will be defined as the date when all participants have made their final visits, the data entered in to the database and all queries resolved and the database locked. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |