MedTrace Logo

Effect of Lantus and Apidra in Patients With Acute ST Elevation Myocardial Infarction

NCT00670228 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2011-02-11

Study results available
· View outcomes & findings →

Summary

Primary objective:

To demonstrate that in hyperglycemic subjects with anterior STEMI (ST Elevation Myocardial Infarction) undergoing Percutaneous Coronary Intervention (PCI), tight glycemic control using insulin glulisine and insulin glargine, i.e. Intensive Insulin Therapy (IIT), results in reducing infarct size at day 60 versus (vs) Standard Glycemic Care (SGC).

Secondary objectives:

To demonstrate that tight glycemic control using insulin glulisine and insulin glargine reduces markers of inflammation and improves Left Ventricular (LV) function and Cardio-Vascular (CV) outcomes from baseline values, in hyperglycemic subjects with STEMI undergoing Percutaneous Coronary Intervention (PCI).

Conditions

  • AMI

Interventions

DRUG

Insulin Glargine (LANTUS)

Subcutaneous insulin glargine was initiated 90 prior to the insulin glulisine infusion discontinuation (i.e. 48 hours after randomization) and titrated as per physician preference to maintain the plasma glucose between 90-130 mg/dL

DRUG

Insulin Glulisine (Apidra)

Prior PCI, subjects received a single IV bolus of insulin glulisine. The dose was 0.025 U/kg based upon patient reported weight. Then IV insulin glulisine infusion was started within one hour of the IV insulin glulisine bolus and administered at a minimum rate of 2 U/h for 48 hours. The infusion was titrated in order to achieve and maintain the plasma glucose between 90 and 130 mg/dL.

DRUG

Standard Therapy

Standard insulin therapy titrated to blood sugar control

Sponsors & Collaborators

Principal Investigators

  • Clinical Study Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2009-11-30
Completion
2009-11-30

Countries

  • United States
  • Argentina
  • Brazil
  • Canada
  • Mexico

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00670228 on ClinicalTrials.gov