Status:
COMPLETED
A Study of Postprandial Hyperglycemia in Participants With Type 2 Diabetes
Lead Sponsor:
Eli Lilly and Company
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
MALE
45-70 years
Phase:
PHASE4
Brief 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 o...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT01159938
Start Date
October 1 2010
End Date
February 1 2013
Last Update
April 3 2014
Active Locations (1)
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1
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Helsinki, Finland, 00014