Hyperglycemia and Cardiovascular Outcomes With Type 2 Diabetes - Full Text View

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00191282

Purpose

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

MedlinePlus related topics: Diabetes Heart Attack

Drug Information available for: Insulin Insulin glargine Insulin lispro Insulin, isophane

U.S. FDA Resources

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)

Further study details as provided by Eli Lilly and Company:

Primary Outcome 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Time until death from any cause or any one of the primary outcomes [ Time Frame: Randomization - occurrence ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as safety issue: Yes ]
Time to occurrence for death from any cause [ Time Frame: Randomization - occurrence ] [ Designated as safety issue: Yes ]
Time to occurrence for CV death [ Time Frame: Randomization - occurrence ] [ Designated as safety issue: Yes ]
Time to occurrence for MI (fatal, nonfatal, any) [ Time Frame: Randomization - occurrence ] [ Designated as safety issue: Yes ]
Time to occurrence for stroke (fatal, nonfatal, any) [ Time Frame: Randomization - occurrence ] [ Designated as safety issue: Yes ]
Time to occurrence for HACS [ Time Frame: Randomization - occurrence ] [ Designated as 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 ] [ Designated as safety issue: Yes ]
Time to occurrence for amputation or revascularization procedure for peripheral vascular disease planned after randomization [ Time Frame: Randomization - occurrence ] [ Designated as safety issue: Yes ]
Time to occurrence for congestive heart failure (newly diagnosed after Visit 2) [ Time Frame: Randomization - occurrence ] [ Designated as safety issue: Yes ]
Incidence and rate of self-reported hypoglycemia [ Time Frame: Randomization, 5-13-26-39-52 weeks then every additional 26 weeks ] [ Designated as safety issue: Yes ]

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.

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	30 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00191282

Show 17 Study Locations

Sponsors and Collaborators

Eli Lilly and Company

Investigators

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

More Information

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

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

Keywords provided by Eli Lilly and Company:

diabetes
MI
heart attack

Study placed in the following topic categories:

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

Additional relevant MeSH terms:

Hypoglycemic Agents
Pathologic Processes
Physiological Effects of Drugs
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009