Various Insulin Regimens for Diabetic Inpatients With Cirrhosis Trial

Plain-language guide to NCT01143948: phase 4 randomized trial of Insulin (regular human) and Insulin Glargine, 45 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT01143948
Phase: phase 4
Status: status unknown
Start: 2011-01
Completion (planned or actual): 2011-04
Participants: 45 (estimated)
Design: randomized, open label (everyone knows who gets what), treatment
Conditions studied: Type 2 Diabetes; Liver Cirrhosis
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

In this phase 4 trial, researchers set out to test Insulin (regular human) and Insulin Glargine.

It had three arms (groups): 15 patient sliding scale regular insulin (active comparator), 15 patient BBI NPH plus regular insulin (active comparator) and 15 patients BBI Glargine plus Glulisine (active comparator).

The registry classes the interventions as drug.

More on the Plan

Best management of hyperglycemia in non-intensive care unit Cirrhotic patients with type 2 diabetes by different insulin regimens either sliding scale regular insulin or basal bolus insulin using NPH \& regular insulin or Glargine \& Glulisine.

Who Took Part

The registry lists 45 planned participants were the target.

It was open to people of any sex aged from 18 years up to 60 years.

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

Examples of who could join: Hospitalized type 2 Diabetes Mellitus with liver cirrhosis.

The full record lists 2 inclusion and 5 exclusion criteria; among the exclusions: type 1 diabetes mellitus; patients in intensive care units.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Because people in this Insulin (regular human) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Everyone knew when Insulin (regular human) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2011-01 with completion listed for 2011-04.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: optimal glycemic control in inpatient cirrhotics (time frame: 3-7 days).

It also tracked 1 secondary outcome, for example Incidence of hypoglycemic episodes.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin (regular human) and Insulin Glargine in 45 people.

Its status is unknown; 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.

Our Notes on the Compounds

Insulin (regular human): The 51-amino-acid pancreatic hormone that lowers blood glucose; this page covers regular (short-acting) insulin studied in human trials.

Insulin Glargine: A long-acting insulin analog given once daily; brands include Lantus, Toujeo, Basaglar and Semglee.

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.