Status:
COMPLETED
Hyperglycemia and Cardiovascular Outcomes With Type 2 Diabetes
Lead Sponsor:
Eli Lilly and Company
Conditions:
Diabetes Mellitus, Type 2
Acute Myocardial Infarction
Eligibility:
All Genders
30+ years
Phase:
PHASE4
Brief Summary
The primary objective was to demonstrate a difference between two insulin strategies, one targeting postprandial (PP) hyperglycemia and the other targeting fasting and interprandial hyperglycemia, on ...
Detailed Description
The purpose of this study is to evaluate the effect of two different treatment strategies on CV outcomes in patients with type 2 diabetes while aiming to achieve and maintain HbA1c \<7.0% in both grou...
Eligibility Criteria
Inclusion
- Are at least 30 years old
- Have had type 2 diabetes for at least 3 months prior to Visit 1
- Were admitted to the Coronary Care Unit (CCU) within 18 days prior to Visit 1 for an acute MI
- Are capable and willing to do specified study procedures
- Have given informed consent to participate in the study in accordance with local regulations
Exclusion
- Were on one of the following therapies prior to admission to the CCU for the recent MI: a)diet therapy only and have glycosylated hemoglobin (HbA1c) \<1.15 times the upper limit of normal or b) an intensive basal/bolus insulin regimen
- Are using any oral antihyperglycemic medication at the time of Visit 2 and are unwilling to stop the use of such medication for the duration of the study
- Have substantial myocardial damage, which would significantly outweigh the potential benefit of the treatment strategies for diabetes
- Have the most severe form of congestive heart failure
- Have liver disease so severe that it precludes the patient from following and completing the protocol
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
1116 Patients enrolled
Trial Details
Trial ID
NCT00191282
Start Date
October 1 2002
End Date
October 1 2007
Last Update
January 20 2011
Active Locations (17)
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1
For additional information regarding investigative sites for this trial, please call 1-877-CTLILLY (1-877-285-4559, 1-317-651-4559), Monday-Friday, 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician
Toronto, Ontario, Canada
2
For additional information regarding investigative sites for this trial, please call 1-877-CTLILLY (1-877-285-4559, 1-317-651-4559), Monday-Friday, 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician
Zagreb, Croatia
3
For additional information regarding investigative sites for this trial, please call 1-877-CTLILLY (1-877-285-4559, 1-317-651-4559), Monday-Friday, 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician
Prague, Czechia
4
For additional information regarding investigative sites for this trial, please call 1-877-CTLILLY (1-877-285-4559, 1-317-651-4559), Monday-Friday, 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician
Dresden, Germany