Hyperglycemia and Cardiovascular Outcomes With Type 2 Diabetes (IONM)

Lilly

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus, Type 2; Acute Myocardial Infarction

Treatments: Drug: Insulin glargine; Drug: Human insulin 30/70; Drug: Insulin lispro; Drug: Human insulin isophane suspension; Drug: Human insulin isophane suspension (NPH)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00191282

5509

F3Z-MC-IONM (Other Identifier)

Details and patient eligibility

About

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).

Full 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 this trial.

Enrollment: 1,116 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

1,116 participants in 2 patient groups

1

Experimental group

Description:

Postprandial: Premeal insulin lispro +/- bedtime NPH

Treatment:

Drug: Human insulin isophane suspension (NPH)

Drug: Insulin lispro

2

Active Comparator group

Description:

Fasting: NPH/insulin glargine or human insulin 30/70

Treatment:

Drug: Insulin glargine

Drug: Human insulin isophane suspension

Drug: Human insulin 30/70