E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
patients who will undergo elective hip surgery with a hyperglycemic
period perioperatively due to surgery. |
|
E.1.1.1 | Medical condition in easily understood language |
patients who will undergo elective hip surgery with a hyperglycemic
period perioperatively due to surgery. |
|
E.1.1.2 | Therapeutic area | Body processes [G] - Metabolic Phenomena [G03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10018418 |
E.1.2 | Term | Glucose blood increased |
E.1.2 | System Organ Class | 10022891 - Investigations |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10020104 |
E.1.2 | Term | Hip total replacement |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
|
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 |
the purpose of this study is to investigate the efficacy of liraglutide to
lower glucose and to influence coagulation activation during and after
hip surgery |
|
E.2.2 | Secondary objectives of the trial |
to influence coagulation activation during and after
hip surgery |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Signed informed consent
Planned for elective hip replacement surgery at the AMC
Age 18-80 years inclusive
Fraxiparine used as anticoagulant drug
|
|
E.4 | Principal exclusion criteria |
Known type 1 or type 2 diabetes mellitus
Oral corticosteroid use
Revision hip replacement
Known coagulation disorders
Peripheral nerve block peri-operative
Pregnancy
Known active cancer of the subject
Any condition that the local investigator feels would interfere with
trial participation or the evaluation of results |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Main study parameter is the difference in mean glucose
between both groups at day 3 after surgery |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Evaluation of the endpoints will be at the end of the study |
|
E.5.2 | Secondary end point(s) |
secondary endpoints are mean differences in coagulation parameters (PAI-1, PAP, F1+2, FVIII, TAT, ETP, PT, APTT,
vWF, D-Dimer and antithrombin levels) and the difference in proportion of patients who have glucose values in fasting state below 7.8 mmol/l at day 3 after surgery. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Evaluation of the endpoints will be at the end of the study |
|
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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 | 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 | 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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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 is defined as the last visit of the last subject
undergoing the trial. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | 0 |