Comparison on Efficacy and Safety of Three Inpatient Insulin Therapy in Type2 DM

What Was Tested

This registered not phased trial tested Insulin (regular human) and Insulin Glargine.

It had three arms (groups): glargine plus supplemental glulisine (active comparator), 70/30 insulin plus supplemental lunch insulin (active comparator) and Sliding Scale insulin (SSI) (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 63 actual participants took part.

It was open to people of any sex aged from 18 years up to 64 years.

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

Examples of who could join: Known history of type 2 DM for longer than 3 months. Age between 18-64 year old,. Treatment with diet alone, any combination of oral antidiabetic agents and/or insulin before admission.

The full record lists 3 inclusion and 5 exclusion criteria; among the exclusions: subjects with hyperglycemia without any known history of dm; presence of diabetic ketoacidosis (dka); patients admitted to intensive care unit (icu).

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.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Being open-label, the Insulin (regular human) study did not mask who received what.

It started in 2010-03 with completion listed for 2014-02.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Mean Daily Blood Glucose (BG) Concentration During Their Hospital Stay (time frame: during hospital stay which is expected to be average 3 weeks). Mean BG After First Day of Hospitalization (time frame: after first day of hospitalization).

It also tracked 3 secondary outcomes, for example Number of Patients Developed Hypoglycemic Events, Number of Patients Developed Episodes of Severe Hyperglycemia and Mortality Rate.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin (regular human) and Insulin Glargine in 63 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Insulin (regular human) compound page and the Insulin Glargine compound page, all human trials.