Official Title: “Hyperglycemia and Its Effect After Acute Myocardial Infarction on Cardiovascular Outcomes in Patients With Type 2 Diabetes (HEART2D)”

A study of patients with type 2 diabetes who have recently had an acute myocardial infarction who receive either premeal insulin lispro and, if necessary, NPH insulin at bedtime or basal insulin or pre-mixed intermediate-acting insulin.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: October 2007

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 groups. Only patients who have recently experienced an acute MI will be considered for participation in thsi trial.

Intervention(s) in this Clinical Trial

• Drug: Insulin lispro
  • Patient adjusted dose, TID, injected SC before each meal until patient completes study
• Drug: Human insulin 30/70
  • Human insulin 30/70 injected SC twice daily before the morning and evening meals until patient completes study.
• Drug: Human insulin isophane suspension
  • Patient adjusted dose, daily at bedtime, injected SC until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%
• Drug: Insulin glargine
  • Insulin glargine injected SC once daily in the evening until patient completes study.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Premeal insulin lispro +/- bedtime NPH
• Active Comparator: 2
  • NPH/insulin glargine or human insulin 30/70

Primary Measures

• To demonstrate difference between the 2 tx strategies on the time until the occurrence of the first event in pts with type 2 DM and acute MI. Combined outcomes: CV death, nonfatal MI, nonfatal stroke, HACS, and coronary revasc after randomization.
  • Time Frame: Randomization - first occurrence
    Safety Issue?: Yes

Secondary Measures

• Time until death from any cause or any one of the primary outcomes
  • Time Frame: Randomization - occurrence
    Safety Issue?: Yes
• Time until the first to occur of any one of the primary outcomes adjusted for other indicators of metabolic control, including HbA1c and fasting blood glucose concentrations
  • Time Frame: Randomization - occurrence
    Safety Issue?: Yes
• Time for the first to occur of any one of the primary outcomes adjusted for major CV risk factors (blood pressure, cholesterol [total, HDL, and LDL], triglycerides, smoking, albuminuria, age, gender, and BMI
  • Time Frame: Randomization - occurrence
    Safety Issue?: Yes
• Time to occurrence for death from any cause
  • Time Frame: Randomization - occurrence
    Safety Issue?: Yes
• Time to occurrence for CV death
  • Time Frame: Randomization - occurrence
    Safety Issue?: Yes
• Time to occurrence for MI (fatal, nonfatal, any)
  • Time Frame: Randomization - occurrence
    Safety Issue?: Yes
• Time to occurrence for stroke (fatal, nonfatal, any)
  • Time Frame: Randomization - occurrence
    Safety Issue?: Yes
• Time to occurrence for HACS
  • Time Frame: Randomization - occurrence
    Safety Issue?: Yes
• Time to occurrence for all coronary revascularization procedures (angioplasty or coronary artery by-pass surgery) planned after randomization
  • Time Frame: Randomization - occurrence
    Safety Issue?: Yes
• Time to occurrence for amputation or revascularization procedure for peripheral vascular disease planned after randomization
  • Time Frame: Randomization - occurrence
    Safety Issue?: Yes
• Time to occurrence for congestive heart failure (newly diagnosed after Visit 2)
  • Time Frame: Randomization - occurrence
    Safety Issue?: Yes
• Incidence and rate of self-reported hypoglycemia
  • Time Frame: Randomization, 5-13-26-39-52 weeks then every additional 26 weeks
    Safety Issue?: Yes

Inclusion Criteria:

• 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 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 Criteria:

• Were on one of the following therapies prior to admission to the CCU for the recent
• MI:a)diet therapy only and have 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 30 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Eli Lilly and Company

Overall Clinical Trial Officials and Contacts

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9am-5pm Eastern time (UTC/GMT - 5 hours, EST) Study Director Eli Lilly and Company  

Information obtained from ClinicalTrials.gov on December 03, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00191282

Study ID Number: 5509

ClinicalTrials.gov Identifier: NCT00191282

Health Authority: United States: Food and Drug Administration

Lilly Clinical Trial Registry