E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Inflammation in patients with type 2 diabetes |
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E.1.1.1 | Medical condition in easily understood language |
Inflammation in patients with type 2 diabetes |
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E.1.1.2 | Therapeutic area | Body processes [G] - Immune system processes [G12] |
MedDRA Classification |
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 study the effect of type 2 diabetes (T2D) on vascular wall inflammatory macrophage accumulation and hematopoietic stem cell composition in vivo, and whether these changes can be reversed by drastically improving metabolic control, using potent glucagon like peptide 1 receptor (GLP1R)-agonism. |
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E.2.2 | Secondary objectives of the trial |
- To compare function and phenotype of bone marrow HSPCs in individuals with T2D before and after treatment with semaglutide. - To evaluate whether 68Ga-Dotatate uptake in aorta, bone marrow, and spleen in individuals with T2D can be reversed after 6 months of treatment with 2.0mg semaglutide once per week. - To correlate the function and phenotype of HSPCs to glucose levels (as captured by HbA1c and continuous glucose monitoring) - To compare phenotype of HSPCs with phenotype of circulating monocytes in T2D patients on GLP1R-agonists. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Age >50 years old - Diagnosed with type 2 diabetes - HbA1c >64mmol/mol |
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E.4 | Principal exclusion criteria |
1. Malignant diseases or any clinically significant medical condition that could interfere with the conduct of the study in the opinion of the investigator. 2. Chronic or recent infections and/or clinical signs of infection and/or a plasma C-reactive protein above 10ng/ml 3. Auto-immune diseases (including type 1 diabetes) 4. Use of any GLP1R-agonist at baseline or prior intolerance to use of GLP1R-agonists. 5. Uncontrolled chronic inflammatory conditions, including gout. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Reduction in coronary 68Ga-Dotatate uptake. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
After 24 weeks of semaglutide treatment. |
|
E.5.2 | Secondary end point(s) |
Changes in phenotype of HSPCs. Reduction in 68Ga-Dotatate uptake in aorta, bone marrow and spleen.
|
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
After 24 weeks of semaglutide treatment. |
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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 | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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 | No |
E.8.2.3 | Other | No |
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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |