A Study of Postprandial Hyperglycemia in Patients With Type 2 Diabetes

• Change in Postprandial Pulse Wave Velocity (PWV) in patients with albuminuria but normal kidney function [ Time Frame: 30 mins (pre-breakfast) ] [ Designated as safety issue: No ]
• Change in Postprandial Pulse Wave Velocity (PWV) in patients with albuminuria but normal kidney function [ Time Frame: 60 mins (post breakfast) ] [ Designated as safety issue: No ]
• Change in Postprandial Pulse Wave Velocity (PWV) in patients with albuminuria but normal kidney function [ Time Frame: 120 mins (post breakfast) ] [ Designated as safety issue: No ]
• Change in Postprandial Pulse Wave Velocity (PWV) in patients with albuminuria but normal kidney function [ Time Frame: 180 mins (post breakfast) ] [ Designated as safety issue: No ]
• Change in Postprandial Pulse Wave Velocity (PWV) in patients with albuminuria but normal kidney function [ Time Frame: 240 mins (post breakfast) ] [ Designated as safety issue: No ]

• Change in Postprandial Pulse Wave Velocity (PWV) in patients with microalbuminuria [ Time Frame: 30 mins (pre-breakfast) ] [ Designated as safety issue: No ]
• Change in Postprandial Pulse Wave Velocity (PWV) in patients with microalbuminuria [ Time Frame: 60 mins (post breakfast) ] [ Designated as safety issue: No ]
• Change in Postprandial Pulse Wave Velocity (PWV) in patients with microalbuminuria [ Time Frame: 120 mins (post breakfast) ] [ Designated as safety issue: No ]
• Change in Postprandial Pulse Wave Velocity (PWV) in patients with microalbuminuria [ Time Frame: 180 mins (post breakfast) ] [ Designated as safety issue: No ]
• Change in Postprandial Pulse Wave Velocity (PWV) in patients with microalbuminuria [ Time Frame: 240 mins (post breakfast) ] [ Designated as safety issue: No ]

• Change in Pulse Wave Amplitude (PWA) [ Time Frame: 30 mins (pre-breakfast), and 60, 120, 180 and 240 mins (post-breakfast) ] [ Designated as safety issue: No ]
• Change in Peripheral Artery Tonometry (PAT) [ Time Frame: 30 mins (pre-breakfast), and 120 and 240 mins (post-breakfast) ] [ Designated as safety issue: No ]
• Change in R wave on Electrocardiogram (ECG) [ Time Frame: 30 mins (pre-breakfast), and 60, 120, 180 and 240 mins (post-breakfast) ] [ Designated as safety issue: No ]
• Change in Blood Glucose (BG) [ Time Frame: 30 mins (pre-breakfast), and 50, 110, 170 and 230 mins (post-breakfast) ] [ Designated as safety issue: No ]
• Change in Postprandial Pulse Wave Velocity (PWV) in patients with normal UAER (urinary albumin excretion rate) and healthy volunteers [ Time Frame: 30 mins (pre-breakfast), and 60, 120, 180 & 240 mins (post breakfast) ] [ Designated as safety issue: No ]

• Change in Pulse Wave Amplitude (PWA) [ Time Frame: 30 mins (pre-breakfast), and 60, 120, 180 and 240 mins (post-breakfast) ] [ Designated as safety issue: No ]
• Change in Peripheral Artery Tonometry (PAT) [ Time Frame: 30 mins (pre-breakfast), and 60, 120, 180 and 240 mins (post-breakfast) ] [ Designated as safety issue: No ]
• Change in R wave on Electrocardiogram (ECG) [ Time Frame: 30 mins (pre-breakfast), and 60, 120, 180 and 240 mins (post-breakfast) ] [ Designated as safety issue: No ]
• Change in Blood Glucose (BG) [ Time Frame: 30 mins (pre-breakfast), and 50, 110, 170 and 230 mins (post-breakfast) ] [ Designated as safety issue: No ]
• Change in Postprandial Pulse Wave Velocity (PWV) in patients with normal UAER (urinary albumin excretion rate) and healthy volunteers [ Time Frame: 30 mins (pre-breakfast), and 60, 120, 180 & 240 mins (post breakfast) ] [ Designated as safety issue: No ]

This Study is looking at whether high blood glucose levels after a meal affect arterial stiffness more or less than low blood glucose levels, and whether certain cardiovascular markers influence the outcome of this.

• Experimental: Patients with albuminuria but normal kidney function
  Intervention: Drug: Lispro
• No Intervention: Healthy volunteer
• Experimental: Patients with normal UAER
  Intervention: Drug: Lispro

Inclusion Criteria:

• Are diagnosed with Type 2 Diabetes Mellitus (T2DM) (according to the American Diabetes Association classification [American Diabetes Association 2006]) and on insulin therapy for at least 6 months.
• Have not smoked in the last 12 hours prior to the study visit.
• Have albuminuria but normal kidney function or normal UAER (UAER < 20 µg/min or < 30 mg/24 hours, respectively). Patients with or without albuminuria but normal kidney function will be matched for age and body mass index (BMI).
• 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.
• Each patient must understand the nature of the study and must sign an informed consent document (ICD).

Healthy subjects are eligible to be included in the study only if they meet all of the following criteria:

• 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.
• Normal glucose tolerance and normal UAER (UAER between < 20 μg/min in the overnight urine collection or < 30 mg/24 hours in the 24-hour urine collection).
• 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.
• Each healthy subject must understand the nature of the study and must sign an ICD.

Exclusion Criteria:

Patients/healthy subjects will be excluded from the study if they meet any of the following criteria:

• 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.
• Have arrhythmias.
• Have an acute infection.
• 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.
• Are unwilling or unable to comply with the use of a data collection device to directly record data from the subject.