A Study to Evaluate the Effect of Nasal Insulin on Postprandial Glycemic Control in Type 2 Diabetic Patients

What Was Tested

In this phase 2 trial, researchers set out to test Insulin Aspart.

Insulin is a hormone which is produced by the human pancreas for the lowering of blood sugar.

In patients who don't produce enough insulin, additional insulin must be given several times per day by injections.

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

Insulin Nasal Spray.

NovoLog.

The registry classes the interventions as drug.

More on the Plan

Insulin aspart is marketed as NovoLog® in the United States and NovoRapid® in Europe.

Once a patient has been successfully titrated with NovoLog and then nasal insulin, they will be randomized to a two-way crossover where they will be given NovoLog and Nasal insulin.

There will be at least a 20 hour washout period between titration and randomization stages.

Patients will be monitored for symptoms consistent with hypoglycemia.

Who Took Part

Enrollment: 18 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Type 2 diabetes for at least 3 months. Type 2 diabetics on oral antidiabetic medicines and/or insulin therapies.

The full record lists 2 inclusion and 3 exclusion criteria; among the exclusions: patients taking intermediate acting insulin such as nph; recurrent severe hypoglycemia; patients with late diabetic complications.

How the Study Was Run

Design: randomized, crossover and open-label.

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

Each person switched between Insulin Aspart and the comparison at some point, usually with a gap in between.

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

It started in 2008-03 with completion listed for 2008-04.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): To evaluate the effect on postprandial glycemic control of intranasal insulin compared to NovoLog (time frame: 4 hour Profile).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin Aspart in 18 people.

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

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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