Hyperglycemia and its effect after acute myocardial infarction on cardiovascular outcomes in patients with Type 2 diabetes mellitus (HEART2D) Study design.
OBJECTIVE
Cardiovascular (CV) disease is the major cause of death in patients with diabetes. Up to 40% of patients with Type 2 diabetes mellitus (T2DM) who survive an initial myocardial infarction (MI) suffer a recurrent event within 2 years, the majority of which are fatal. One independent risk factor for cardiovascular disease (CVD) may be postprandial blood glucose (PPBG) excursions. The HEART2D study seeks to determine the effect that PPBG control has on cardiovascular outcomes in patients who suffered an MI within the 21 days before study enrollment.


METHODS
Approximately 1355 patients with T2DM with recent MI will be entered in this multicenter study of about 3.0-year duration. Using infarct severity and peri-infarct treatment as randomization factors, patients will be assigned to one of two insulin treatment strategies: (1) postprandial strategy: premeal insulin lispro with basal insulin at bedtime if needed (NPH insulin), targeting 2-h PPBG < or = 7.5 mmol/l or (2) basal strategy: insulin (NPH insulin twice daily or insulin glargine once daily; or premixed human insulin (70% NPH/30% regular; 30/70) twice daily), targeting fasting and premeal blood glucose (BG; < or = 6.7 mmol/l). Both groups will aim for a target hemoglobin AlC (AlC) of < 7%.


RESULTS
The anticipated difference in PPBG (approximately 2.0 to 2.5 mM) between strategies is expected to demonstrate a 15% to 18.5% relative risk reduction in CV events for the postprandial strategy.


CONCLUSIONS
This study may provide practical insights into the clinical management of patients with diabetes who have an increased risk of recurrent CV events and death.
Milicevic
Zvonko
Z
Eli Lilly and Company, Vienna, Austria. milicevic_zvonko@lilly.com
Raz
Itamar
I
Strojek
Krzysztof
K
Skrha
Jan
J
Tan
Meng H
MH
Wyatt
John W
JW
Beattie
Scott D
SD
Robbins
David C
DC
D003924:Diabetes Mellitus, Type 2 / Q000097:blood*; D004334:Drug Administration Schedule; D005215:Fasting; D006801:Humans; D006943:Hyperglycemia / Q000503:physiopathology*; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D007328:Insulin / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D000069036:Insulin Glargine; D061268:Insulin Lispro; D049528:Insulin, Long-Acting; D009203:Myocardial Infarction / Q000097:blood*; D019518:Postprandial Period
D007004:Hypoglycemic Agents; D007328:Insulin; D061268:Insulin Lispro; D049528:Insulin, Long-Acting; D000069036:Insulin Glargine