Type 2 diabetes
Conditions
Interventions
Trade Name: Humalog
Product Name: Humalog
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INSULIN LISPRO
CAS Number: 133107-64-9
Concentration unit: U/ml unit(s)/millilitre
Concentrat
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
Male
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: 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 ;Primary end point(s): | — |
Countries
Finland
Contacts
Public ContactClinical trial information
Eli Lilly
Outcome results
None listed