Clinical Trials
DIGAMI 2 Trial
Trial Details:
Acronym: Diabetes and Insulin-Glucose infusion in Acute Myocardial Infarction 2 Trial
Purpose: To evaluate strict glucose control in patient with acute coronary syndromes and confirm the findings of the DIGAMI Trial.
Format: Doubleblind, multicenter, randomized control trial
Treatment Group: Insulin IV infusion (insulin drip) then either insulin OR standard treatment
Control Group: Routine diabetes management
Number of Patients: 1,253
Inclusion Criteria:
- Diabetes Mellitus Type II
- Admission glucose level > 11 mmol/L
- Suspected acute coronary syndrome
Exclusion Criteria:
- Inability to cope with insulin treatment
Follow-up: Mean of 2.1 years
Primary Endpoint: All-cause mortality between the longer term insulin versus the standard treatment
Secondary Endpoint: All-cause mortality between the early insulin only (not long term) versus the standard treatment
Summary:
Evaluated the use of long-term insulin for better glucose control in diabetics presenting with acute coronary syndromes. All patients received insulin infusion then were randomized to a long-term insulin regimen or standard therapy. There was no evidence that long-term insulin improves survival or re-infarction compared to standard therapy. Glucose levels were determined to be a strong predictor of long-term mortality.
Original Publication:
Malmberg K, et al. Eur Heart J. 2005;doi:10.1093/eurheartj/ehi199.