Early Subcutaneous Insulin Glargine Plus Standard of Care for Treatment of Diabetic Ketoacidosis

What Was Tested

The trial (not phased) is built around Insulin (regular human) and Insulin Glargine.

The purpose of this study is to determine whether adult DKA patients who present to the emergency department treated with early subcutaneous long acting insulin versus standard care receive a shorter total duration of intravenous (IV) insulin infusion.

It had two arms (groups): one (experimental) and Standard therapy (placebo comparator).

Subcutaneous insulin glargine will be administered within two hours of starting the IV insulin infusion.

Retrospective arm that received standard insulin therapy for treatment of DKA.

The registry classes the interventions as drug and other.

More on the Plan

Specific Aims: To evaluate the impact of early administration of subcutaneous glargine versus standard care on time of insulin infusion in DKA patients and other secondary outcomes listed in this application.

Patients enrolled in the prospective arm will be compared with the retrospective control group, which received standard insulin therapy (subcutaneous insulin glargine administered at least 2 to 3 hours prior to termination of the insulin infusion).

There will be 18 patients in this group selected in reverse chronological order from their pre-specified date range of 8/1/2014 to 7/31/2016.

Who Took Part

Enrollment: 18 actual participants took part.

It was open to people of any sex aged from 18 years up to 89 years.

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

Examples of who could join: Anion gap \>16. Ketonemia or ketonuria.

The full record lists 4 inclusion and 3 exclusion criteria; among the exclusions: pregnant women; refused consent; patient left ed against medical advice.

How the Study Was Run

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

The Insulin (regular human) group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Insulin (regular human) study: the participants and staff both knew the treatment.

It started in 2016-10 with completion listed for 2021-11-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Duration of intravenous insulin infusion (time frame: up to 10 months).

It also tracked 7 secondary outcomes, for example Time to resolution of high serum glucose (hyperglycemia), Time to closure of anion gap, Time to correction of bicarbonate, Time to correction of serum pH, Total duration of hospital stay and Return of DKA within 24 hours.

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of Insulin (regular human) and Insulin Glargine 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 (regular human) compound page and the Insulin Glargine compound page, all human trials.