A Study of Postprandial Hyperglycemia in Participants With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Hyperglycemia
Intervention: Lispro
Intervention description: Dosage based on participants with type 2 diabetes mellitus (T2DM) normal morning insulin dose and energy content of participant's normal breakfast. Subcutaneous injection given on one occasion. Administered once on low post prandial day.
Intervention MeSH terms: Insulin Lispro
Phase: Phase 4
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 72.0
Sex: Male
Minimum age: 45 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are diagnosed with 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 micrograms per
             minute (mcg/min) or < 30 milligrams/24 hours (mg/24h), respectively]. Participants
             with or without albuminuria but normal kidney function will be matched for age and
             body mass index (BMI).

          -  Participants 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 participant must understand the nature of the study and must sign an informed
             consent document (ICD).

        Healthy participants are eligible to be included in the study only if they meet all of the
        following criteria:

          -  Healthy participants 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/24h in the 24-h urine collection).

          -  Healthy participants 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 participant must understand the nature of the study and must sign an ICD.

        Exclusion Criteria:

        Participants/healthy participants 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 participant.