Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug3067 | Prednisolone Wiki | 1.00 |
| drug2916 | Placebo Wiki | 0.04 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D003924 | Diabetes Mellitus, Type 2 NIH | 0.24 |
| D003920 | Diabetes Mellitus, NIH | 0.17 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0005978 | Type II diabetes mellitus HPO | 0.24 |
| HP:0000819 | Diabetes mellitus HPO | 0.17 |
Navigate: Correlations HPO
There is one clinical trial.
The study is intended to assess the effect on glycaemic control of AZD9567, as measured by the glucose AUC(0-4) versus baseline following a standardised mixed meal tolerance test (MMTT), compared to prednisolone in adults with type 2 diabetes mellitus (T2DM). The study will also evaluate the safety, tolerability, and pharmacokinetics (PK) of AZD9567.
Description: The change from baseline in glucose AUC(0-4) will be analysed using a mixed model repeated measures (MMRM) with baseline included as covariate.
Measure: Change in glucose AUC(0-4) versus baseline compared to prednisolone following a standardised MMTT Time: On Days -1, 4, 27, and 31Description: The mean daily glucose will be analysed using a MMRM analysis with baseline as covariate.
Measure: Mean daily glucose at 48 - 72 hours treatment as determined from multiple measures via the Continuous Glucose Monitoring (CGM) system Time: On Days -2, 3, 26 and 30Description: The mean daily glucose will be analysed using an MMRM analysis with baseline as covariate.
Measure: Rise in mean daily glucose over 24-hour periods from start of IMP dosing (0 - 24 hours, 24 - 48 hours, 48 - 72 hours) Time: On Days 1, 2, 3, 28, 29, 30Description: Pharmacodynamic effects of AZD9567 will be evaluated as compared to prednisolone.
Measure: Change from baseline in fasting glucose Time: On Days -1, 4, 27, and 31Description: Effects on insulin, glucagon, GLP-1 and GIP of AZD9567 following MMTT in comparison to prednisolone will be assessed.
Measure: Change from baseline AUC(0-4) on hormones related to glucose homeostasis Time: On Days -1, 4, 27, and 31Description: Pharmacodynamic effects of AZD9567 on glucose homeostasis through a MMTT in comparison to prednisolone will be assessed.
Measure: Change from baseline in AUC(0-4) on C-peptide Time: On Days -1, 4, 27, and 31Description: Pharmacodynamic effects of AZD9567 on derived measures of beta cell function from the MMTT compared to prednisolone will be evaluated.
Measure: MMTT derived first phase insulin response Time: On Days -1, 4, 27, and 31Description: The concentration of potassium in urine will be measured over 24 hours.
Measure: 24-hour potassium concentration Time: On Days -1, 3, 27 and 30Description: The concentration of sodium in urine will be measured over 24 hours.
Measure: 24-hour sodium concentration Time: On Days -1, 3, 27 and 30Description: AUClast will be derived using standard non-compartmental methods using WinNonLin version 8.1 or higher (Certara).
Measure: Area under the plasma concentration versus time curve from zero to the last quantifiable concentration (AUClast) Time: On Days 3, 4, 30, and 31 (Pre-dose, Post-dose 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30 hours)Description: AUC(0-24) will be derived using standard non-compartmental methods using WinNonLin version 8.1 or higher (Certara).
Measure: Area under the plasma concentration versus time curve from zero to 24 hours post-dose [AUC(0-24)] Time: On Days 3, 4, 30, and 31 (Pre-dose, Post-dose 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30 hours)Description: AUC(0-6) will be derived using standard non-compartmental methods using WinNonLin version 8.1 or higher (Certara).
Measure: Area under the plasma concentration versus time curve from zero to 6 hours post-dose [AUC(0-6)] Time: On Days 3, 4, 30, and 31 (Pre-dose, Post-dose 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30 hours)Description: Cmax will be derived using standard non-compartmental methods using WinNonLin version 8.1 or higher (Certara).
Measure: Maximum observed drug concentration (Cmax) Time: On Days 3, 4, 30, and 31 (Pre-dose, Post-dose 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30 hours)Description: Tmax will be derived using standard non-compartmental methods using WinNonLin version 8.1 or higher (Certara).
Measure: Time to reach maximum observed drug concentration (tmax) Time: On Days 3, 4, 30, and 31 (Pre-dose, Post-dose 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30 hours)Description: t½λz will be derived using standard non-compartmental methods using WinNonLin version 8.1 or higher (Certara).
Measure: Terminal elimination half-life (t½λz) Time: On Days 3, 4, 30, and 31 (Pre-dose, Post-dose 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30 hours)Description: CL/F will be derived using standard non-compartmental methods using WinNonLin version 8.1 or higher (Certara).
Measure: Apparent total body clearance of drug from plasma after extravascular (CL/F) Time: On Days 3, 4, 30, and 31 (Pre-dose, Post-dose 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30 hours)Description: Vz/F will be derived using standard non-compartmental methods using WinNonLin version 8.1 or higher (Certara).
Measure: Apparent volume of distribution following extravascular administration (Vz/F) Time: On Days 3, 4, 30, and 31 (Pre-dose, Post-dose 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30 hours)Description: Relationship between AZD9567 exposure and inhibition of LPS-stimulated TNFα release for high and low dose comparison (Cohort 1 and Cohort 2) will be assessed.
Measure: TNFα concentrations Time: On Days 3 and 30 (Pre-dose, Post-dose 1, 2, 4, 8, 12, and 24 hoursDescription: Pharmacodynamic effects of AZD9567 will be evaluated following a MMTT compared to prednisolone.
Measure: Change in free fatty acids Time: On Days -1, 4, 27, and 31Description: Pharmacodynamic effects of AZD9567 on derived measures of beta cell function from the MMTT compared to prednisolone will be evaluated.
Measure: Homeostatic model assessment- insulin resistance (HOMA-IR) Time: On Days -1, 4, 27, and 31Description: Pharmacodynamic effects of AZD9567 on derived measures of beta cell function from the MMTT compared to prednisolone will be evaluated.
Measure: HOMA-insulin sensitivity Time: On Days -1, 4, 27, and 31Description: Pharmacodynamic effects of AZD9567 on derived measures of beta cell function from the MMTT compared to prednisolone will be evaluated.
Measure: Modified Matsuda index Time: On Days -1, 4, 27, and 31Description: Safety and tolerability will be assessed using variables like AEs/SAEs, vital signs, ECGs, changes in clinical chemistry/haematology parameters, morning serum cortisol, and adrenocorticotropic hormone.
Measure: Safety and tolerability of AZD9567 by assessing the number of participants with adverse events Time: From screening up to 79 daysAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports