A Study of Postprandial Hyperglycemia in Participants With Type 2 Diabetes

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2013-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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T2DM, albuminuria but normal kidney function

Group Type EXPERIMENTAL

Lispro

Intervention Type DRUG

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.

Healthy participants

Group Type NO_INTERVENTION

No interventions assigned to this group

T2DM, normal urinary albumin excretion rate (UAER)

Group Type EXPERIMENTAL

Lispro

Intervention Type DRUG

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.

Interventions

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Lispro

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 Type DRUG

Other Intervention Names

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Humalog LY275585

Eligibility Criteria

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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.

Minimum Eligible Age

45 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes