Combination of Sulfonylureas and Insulin Glargine Outpatient Therapy for Unstable Diabetes and Impending DKA

What Was Tested

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

It had two arms (groups): Glipizide arm (active comparator) and Glipizide + Glargine (active comparator).

Insulin Glargine is a recombinant human basal insulin analog. It was chosen since it is a non-peaking insulin with cover for 24 hours. It can be injected subcutaneously only once a day and has a low incidence of hypoglycemia.

The registry classes the interventions as drug.

More on the Plan

This study is an open label randomized controlled trial in adult DM2 patients seen in ED services at John H.

Who Took Part

80 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

The full record lists 1 inclusion and 10 exclusion criteria; among the exclusions: acute complications of chronic cardiovascular, neurological, renal, and other diabetic complications; electrolyte imbalances (serum bicarbonate level \< 20 meq/l, serum sodium \< 125 \& \> 150 meq/l, serum potassium \< 3.5 \& \> 5.5 meq/l); evidence of an impaired sensorium and/or dementia.

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 2004-09 with completion listed for 2006-04.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: The primary outcome was the patients' ability to avoid repeat ED visits or hospitalization in either of the discharge regimens (time frame: 2 months).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine in 80 people.

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

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