Effect of a Basal/Pre-Meal Insulin Strategy (Detemir/Aspart) on Insulin Secretion and Action in Type 2 Diabetes

What Was Tested

The trial (phase 4) is built around Insulin Aspart and Insulin Detemir.

This study is to determine the effect on hepatic steatosis and insulin secretion/action of lowering the fasting plasma glucose (FPG) to target with once daily basal insulin detemir alone or combining insulin detemir with premeal insulin aspart in patients with uncontrolled type 2 diabetes mellitus (T2DM).

In the first 3 months the investigators will optimize metabolic control in all patients with intensive basal (bedtime) detemir insulin aiming at a normal fasting plasma glucose.

It had two arms (groups): Insulin detemir only (active comparator) and Insulin detemir plus aspart (experimental).

The registry classes the interventions as drug.

More on the Plan

Insulin detemir is an insulin analogue approved in 2005 by the FDA.

Who Took Part

30 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Be able to communicate meaningfully with the Investigator and be legally competent to provide written informed consent. Age range of 18 to 70 years (inclusive). All participants must have the following laboratory values:. AST (SGOT) ≤ 2.5 times upper limit of normal. ALT (SGPT) ≤ 2.5 times upper limit of normal.

The full record lists 10 inclusion and 5 exclusion criteria; among the exclusions: past (within 1 year) or current history of alcohol abuse.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Insulin Aspart and who got the comparison, which limits bias.

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

Being open-label, the Insulin Aspart study did not mask who received what.

It started in 2007-06 with completion listed for 2010-02.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Hepatic Steatosis (time frame: 3 and 6 months).

It also tracked 11 secondary outcomes, for example Metabolic Control as Measured by the A1c, Change in Insulin Secretion, Intramyocellular (IMCL) by Magnetic Resonance Imaging and Spectroscopy (MRS), Plasma Lipid Concentration, Change in Anthropometric Measure (Body Weight) and Number of Hypoglycemic Events.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Aspart and Insulin Detemir in 30 people.

Its size is small, so on its own it can only give an early look.

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

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