Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Eli Lilly and Company |
---|---|
Information provided by: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT00191282 |
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.
Condition | Intervention | Phase |
---|---|---|
Diabetes Mellitus, Type 2 Acute Myocardial Infarction |
Drug: Insulin lispro Drug: Human insulin 30/70 Drug: Human insulin isophane suspension Drug: Insulin glargine |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Hyperglycemia and Its Effect After Acute Myocardial Infarction on Cardiovascular Outcomes in Patients With Type 2 Diabetes (HEART2D) |
Enrollment: | 1108 |
Study Start Date: | October 2002 |
Study Completion Date: | October 2007 |
Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Premeal insulin lispro +/- bedtime NPH
|
Drug: Insulin lispro
Patient adjusted dose, TID, injected SC before each meal 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%
|
2: Active Comparator
NPH/insulin glargine or human insulin 30/70
|
Drug: Human insulin 30/70
Human insulin 30/70 injected SC twice daily before the morning and evening meals until patient completes study.
Drug: Insulin glargine
Insulin glargine injected SC once daily in the evening until patient completes study.
|
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.
Ages Eligible for Study: | 30 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9am-5pm Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
Responsible Party: | Eli Lilly ( Chief Medical Officer ) |
Study ID Numbers: | 5509, F3Z-MC-IONM |
Study First Received: | September 12, 2005 |
Last Updated: | September 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00191282 |
Health Authority: | United States: Food and Drug Administration |
diabetes MI heart attack |
Metabolic Diseases Heart Diseases Myocardial Ischemia Diabetes Mellitus Vascular Diseases Insulin LISPRO Endocrine System Diseases Ischemia Insulin, Isophane Insulin |
Necrosis Hyperglycemia Diabetes Mellitus, Type 2 Glargine Endocrinopathy Metabolic disorder Infarction Glucose Metabolism Disorders Myocardial Infarction |
Hypoglycemic Agents Pathologic Processes Physiological Effects of Drugs Cardiovascular Diseases Pharmacologic Actions |