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Completed

NCT Number: NCT00191282

Hyperglycemia and Cardiovascular Outcomes With Type 2 Diabetes

The primary objective was to demonstrate a difference between two insulin strategies, one targeting postprandial (PP) hyperglycemia and the other targeting fasting and interprandial hyperglycemia, on time until the first combined adjudicated cardiovascular (CV) event (primary outcome defined as CV death, nonfatal myocardial infarction [MI], nonfatal stroke, coronary revascularization, or hospitalized acute coronary syndrome).

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Key information

Conditions

Diabetes Mellitus, Type 2 Acute Myocardial Infarction Cardiovascular Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Infarction Ischemia Metabolic Diseases Myocardial Infarction Myocardial Ischemia Necrosis Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

For additional information regarding investigative sites for this trial, please call 1-877-CTLILLY (1-877-285-4559, 1-317-651-4559), Monday-Friday, 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician, Toronto, Ontario, Canada

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About this 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 this trial.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 (CCU) 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 glycosylated hemoglobin (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

Treatment and study plan

Insulin Lispro

Drug

Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study

Other names: Humalog

Human insulin isophane suspension (NPH)

Drug

Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%

insulin glargine

Drug

Insulin glargine injected subcutaneous (SC) once daily in the evening until patient completes study.

Human insulin isophane suspension

Drug

Patient adjusted dose, twice daily, injected subcutaneous (SC) before morning and evening meals until patient completes study.

Human insulin 30/70

Drug

Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.

Other names: Human insulin 70/30 (in the United States)

Primary outcomes

  1. Number of Participants Who Experienced a Primary Combined Outcome

    Time frame: Randomization (Day 0) until first occurrence of primary combined outcome (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)

    The combined study outcomes consisted of cardiovascular (CV) death, nonfatal myocardial infarction (MI), nonfatal stroke, hospitalization for acute coronary syndromes (HACS), and coronary revascularization procedures planned after randomization.

Secondary outcomes

  1. Number of Participants Who Experienced Death From Any Cause or Any One of the Primary Outcomes

    Time frame: Randomization (Day 0) until death from any cause or one of the primary outcomes (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)

    Primary outcomes in this study consisted of: cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, hospitalization for acute coronary syndromes (HACS), and coronary revascularization procedure planned after randomization.

  2. Number of Participants Who Experienced Any One of the Primary Outcomes Adjusted for Indicators of Metabolic Control

    Time frame: Randomization (Day 0) until occurrence of primary outcome (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)

    Indicators of metabolic control included glycosylated hemoglobin (HbA1c) and fasting blood glucose concentrations.

  3. Number of Participants Who Experienced Primary Outcomes Adjusted for Metabolic Control and Major Cardiovascular (CV) Risk Factors

    Time frame: Randomization (Day 0) until occurrence of primary outcome (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)

    Primary outcomes adjusted for major cardiovascular (CV) risk factors (blood pressure, cholesterol [total, high density lipoprotein (HDL), and low density lipoprotein (LDL)], triglycerides, smoking, albuminuria, age, gender, and body mass index (BMI).

  4. Number of Participants Who Experienced Death From Any Cause

    Time frame: Randomization (Day 0) until death from any cause (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)

  5. Number of Participants Who Experienced Cardiovascular (CV) Death

    Time frame: Randomization (Day 0) until cardiovascular death (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)

  6. Number of Participants Who Experienced Myocardial Infarction (MI)

    Time frame: Randomization (Day 0) until myocardial infarction (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)

    Occurrence of myocardial infarction (MI) (fatal, nonfatal, any).

  7. Number of Participants Who Experienced Stroke

    Time frame: Randomization (Day 0) until stroke (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)

    Occurrence of stroke (fatal, nonfatal, any).

  8. Number of Participants Who Experienced Hospitalization for Acute Coronary Syndromes (HACS)

    Time frame: Randomization (Day 0) until HACS (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)

  9. Number of Participants Who Experienced Coronary Revascularization Procedures

    Time frame: Randomization (Day 0) until coronary revascularization procedures (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)

    Occurrence of all coronary revascularization procedures (angioplasty or coronary artery by-pass surgery) planned after randomization.

  10. Number of Participants Who Experienced Amputation for Peripheral Vascular Disease Planned After Randomization

    Time frame: Randomization (Day 0) until amputation (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)

  11. Number of Participants Who Experienced Congestive Heart Failure

    Time frame: Randomization (Day 0) until congestive heart failure (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)

    Occurrence of congestive heart failure (newly diagnosed after Visit 2).

  12. Number of Participants Who Experienced Revascularization Procedure for Peripheral Vascular Disease Planned After Randomization

    Time frame: Randomization (Day 0) until revascularization procedure (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)

  13. Number of Participants Who Experienced Coronary Angiography Planned After Randomization

    Time frame: Randomization (Day 0) until coronary angiography (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)

  14. Number of Participants With Self-Reported Hypoglycemia During Month 1

    Time frame: Visit 3 (Month 1)

    Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL).

  15. Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 1

    Time frame: Visit 3 (Month 1)

    Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL).

  16. Number of Participants With Self-Reported Hypoglycemia During Month 3

    Time frame: Visit 4 (Month 3)

    Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL).

  17. Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 3

    Time frame: Visit 4 (Month 3)

    Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL).

  18. Number of Participants With Self-Reported Hypoglycemia During Month 6

    Time frame: Visit 5 (Month 6)

    Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL).

  19. Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 6

    Time frame: Visit 5 (Month 6)

    Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL).

  20. Number of Participants With Self-Reported Hypoglycemia During Month 9

    Time frame: Visit 6 (Month 9)

    Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL).

  21. Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 9

    Time frame: Visit 6 (Month 9)

    Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL).

  22. Number of Participants With Self-Reported Hypoglycemia During Month 12

    Time frame: Visit 7 (Month 12)

    Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL).

  23. Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 12

    Time frame: Visit 7 (Month 12)

    Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL).

  24. Number of Participants With Self-Reported Hypoglycemia During Month 18

    Time frame: Visit 8 (Month 18)

    Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL).

  25. Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 18

    Time frame: Visit 8 (Month 18)

    Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL).

Other outcomes

  1. Summary of Reasons for Deaths

    Time frame: Randomization (Day 0) to death (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Acronym: IONM

Important dates

Study start
2002
Primary completion
2007
Study completion
2007
First posted
Sep 19, 2005
Registry last updated
Jan 20, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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