Effects of Short-term Intensive Insulin Therapy in Newly Diagnosed Type 2 Diabetes Patients

What Was Tested

This registered not phased trial tested Insulin Aspart.

It is well known that Long-term hyperglycemia (also known as glucose toxicity) contribute to impairment in islet β-cell function and development of insulin resistance.

A growing body of evidence also indicates that this impairment inβ-cell function and insulin action could be restored after hyperglycemia is corrected by short-term intensive insulin therapy.

The registry classes the interventions as drug.

Who Took Part

130 planned participants were the target.

It was open to people of any sex aged from 25 years up to 60 years.

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

Examples of who could join: Age: 25 to 60 years old. Duration of diabetes: newly diagnosed type 2 diabetes (duration of diabetes less than 1 year) and haven't taken any antidiabetic medication. Half of the patients with BMI below 24 and the other half with BMI above 24.

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: type 1 diabetes mellitus; type 2 diabetes patients with intercurrent illness (ketoacidosis, infection or any other acute stress); presence of auto-immune disease, hepatic or renal disease or any concomitant disease is not allowed.

How the Study Was Run

It was run as a single-group and open-label study.

Nothing was hidden in this open-label Insulin Aspart study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2008-10 with completion listed for 2012-12.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: AUC75-120 of Glucose Infusion Rate (GIR) (time frame: after 2 weeks insulin pump intensive therapy, and one-year follow-up after termination of treatments).

It also tracked 1 secondary outcome, for example AUC0-10 of Acute Insulin Response (AIR) during IVGTT.

What This Means in Plain Language

Put simply, this is a not phased trial of Insulin Aspart in 130 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin Aspart compound page, all human trials.