Hyperglycemia and Cardiovascular Outcomes With Type 2 Diabetes

What Was Tested

This registered phase 4 trial tested Insulin Glargine and Insulin Lispro.

It had two arms (groups): 1 (experimental) and 2 (active comparator).

Postprandial: Premeal insulin lispro +/- bedtime NPH.

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

The registry classes the interventions as drug.

More on the Plan

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

Who Took Part

The registry lists 1116 actual participants took part.

It was open to people of any sex aged from 30 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: 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.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

The participants were allocated by chance, so the Insulin Glargine group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Everyone knew when Insulin Glargine was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2002-10 with completion listed for 2007-10.

It ran at 17 sites in Canada (1), Croatia (1), Czechia (1), Germany (1), Hungary (1) and India (1).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Number of Participants Who Experienced a Primary Combined Outcome.

It also tracked 25 secondary outcomes, for example Number of Participants Who Experienced Any One of the Primary Outcomes Adjusted for Indicators of Metabolic Control, Number of Participants Who Experienced Primary Outcomes Adjusted for Metabolic Control and Major Cardiovascular (CV) Risk Factors, Number of Participants Who Experienced Myocardial Infarction (MI), Number of Participants Who Experienced Stroke, Number of Participants Who Experienced Hospitalization for Acute Coronary Syndromes (HACS) and Number of Participants Who Experienced Coronary Revascularization Procedures.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine and Insulin Lispro in 1116 people.

With 1116 participants it is a large trial for this field.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Insulin Glargine compound page and the Insulin Lispro compound page, all human trials.