Veterans Inpatient Insulin Study and Transition to Outpatient Therapy

What Was Tested

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

Volunteers are being invited to take part in a research study about insulin therapy of diabetes.

They are being invited to take part in this research study because they have diabetes and have an illness requiring hospitalization.

If they volunteer to take part in this study, they will be one of about 120 people to do so.

It had two arms (groups): NPH/Regular 70/30 mix (active comparator) and Aspart insulin analog biphasic mix (active comparator).

Transition insulin therapy with NPH/Regular 70/30 mix for outpatient glycemic control following a hospitalization for non-critical acute illness.

Transition insulin therapy with Aspart insulin analog 70/30 mix for outpatient glycemic control following a hospitalization for non-critical acute illness.

The registry classes the interventions as drug.

More on the Plan

By doing this study, the researchers hope to learn the optimal way to use insulin therapy to treat individuals during a hospitalization for an illness as well as during the recovery phase of the illness for twenty-four weeks after discharge from the hospital.

Who Took Part

The registry lists 120 actual participants took part.

It was open to people of any sex aged from 40 years with no upper age limit.

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

Examples of who could join: Diagnosed with type 2 diabetes for duration of three-months or longer. Greater than or equal to 40 years of age. Written informed consent to participate in the study. Admitted for hospitalization at VA Medical Center Lexington, KY. Able and willing to do the following:.

The full record lists 10 inclusion and 13 exclusion criteria; among the exclusions: have developed a severe illness requiring treatment in an intensive care unit as determined by your admitting physician; are a woman who is breastfeeding; have a history of heart disease that limits your physical activity.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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

The Insulin Aspart group and the comparison group ran side by side rather than switching.

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

It started in 2009-03-11 with completion listed for 2013-04-23.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): For Transition From Inpatient to Outpatient Care, Evaluate Glycemic Control in Subjects Randomized to Receive 70/30 NPH/Regular Insulin or Aspart Analog 70/30 Mix Bid- Main Outcome Will be HbA1c During Transition Outpatient Therapy Phase (time frame: 16 weeks).

It also tracked 4 secondary outcomes, for example Seven Point Blood Glucose Profiles, Patient-reported Outcomes - Diabetes Symptom Checklist to Evaluate Perception of Diabetes Control, Hypoglycemia and Twice Daily Blood Glucose Monitoring Using Telehealth Transmitter.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Aspart in 120 people.

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, all human trials.