E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nutritional and Metabolic Diseases [C18] |
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 examine in T2DM patients whether pulse wave velocity (PWV) differs between postprandial hyperglycemia and nearly normal postprandial glycemia, and whether microalbuminuria influences the outcome of this comparison. |
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E.2.2 | Secondary objectives of the trial |
To compare postprandial PWV between T2DM patients with microalbuminuria, patients with normal UAER and healthy subjects.
To compare baseline (fasting) PWV, pulse wave amplitude (PWA), and peripheral arterial tonometry (PAT) between T2DM patients with microalbuminuria, patients with normal UAER and healthy subjects.
further secondary objectives please see protocol |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Diabetic patients are eligible to be included in the study only if they meet all of the following criteria:
[1] Men 45 to 70 years of age.
[2] Are diagnosed with T2DM (according to the American Diabetes Association classification [American Diabetes Association 2006]) and on insulin therapy for at least 6 months.
[3] Have not smoked in the last 12 hours prior to the study.
[4] Have albuminuria but normal kidney function or normal UAER (UAER <20 µg/min or <30 mg/24h, respectively). Patients with or without albuminuria but normal kidney function will be matched for age and BMI.
[5] Patients have been judged by the investigator to be reliable to keep appointments for clinic visits and all tests and examinations required by the protocol.
[6] Each patient must understand the nature of the study and must sign an ICD.
Healthy subjects are eligible to be included in the study only if they meet all of the following criteria:
[7] Men 45 to 70 years of age, matched for age and BMI, who have not smoked in the last 12 hours prior to the study.
[8] Normal glucose tolerance (according to the World Health Organization [WHO] criteria, i.e. fasting glucose <6,1 mmol/L and 2-hour glucose <7,8 mmol/L) and normal UAER (UAER between <20 µg/min in the overnight urine collection or <30 mg/24h in the 24 hour urine collection).
[9] Healthy subjects have been judged by the investigator to be reliable to keep appointments for clinic visits and all tests and examinations required by the protocol.
[10] Each healthy subject must understand the nature of the study and must sign an ICD.
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E.4 | Principal exclusion criteria |
Patients/healthy subjects will be excluded from the study if they meet any of the following criteria:
[11] Have had a cardiovascular event (stroke, myocardial infarction [MI], coronary artery procedure [by-pass surgery or angioplasty], limb amputation due to ischemia, peripheral vascular disease) or coronary heart disease confirmed by exercise test or scintigraphy.
[12] Have arrhythmias.
[13] Have an acute infection.
[14] Are investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
[15] Are Lilly employees.
[16] Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device or off label use of a drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
[17] Are unwilling or unable to comply with the use of a data collection device to directly record data from the subject.
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E.5 End points |
E.5.1 | Primary end point(s) | |
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 | 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 | Yes |
E.6.13.1 | Other scope of the trial description |
examination of surrogate marker for macrovascular complications in T2DM patients |
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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 | Yes |
E.8.1.1 | Randomised | Yes |
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 | Yes |
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 | Yes |
E.8.2.3.1 | Comparator description |
the control is no treatment |
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E.8.2.4 | Number of treatment arms in the trial | 3 |
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 | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |