Comparison of Neutral Protamine Hagedorn (NPH) and Lantus Based Insulin Regimen in the Management of Hypoglycemia in the Hospitalized Patients in Noncritical Care Setting

What Was Tested

This registered phase 4 trial tested Insulin Glargine and Insulin Lispro.

Primary outcome of the study is to determine differences in glycemic control between treatment group as measured by the mean daily blood glucose.

Secondary outcome is to measure number of hypoglycemic events, number of severe hypoglycemia and length of hospital stay.

It had two arms (groups): NPH and regular insuline group (experimental) and glargine and humalog group (active comparator).

The registry classes the interventions as drug.

More on the Plan

Although effect on glucose disposal is the central to insulin action, there could be differences of insulin action on other metabolic parameters.

It is unknown if natural insulin (NPH, recombinant human insulin with protamine) differs from insulin analogs (glargine and detemir, made by substituting amino acid in the native sequence) in terms of metabolic outcome other than glucose disposal.

Currently, both lantus and NPH based regimen is practiced in inpatient hospital setting.

Current practice of inpatient insulin regimen is based more on familiarity of physicians with a particular insulin type and personal preference rather than evidenced based knowledge.

Who Took Part

Enrollment: 52 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

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

Examples of who could join: Other inclusion criteria are as follows:. Age 18-80 years old. Treated with diet alone.

The full record lists 5 inclusion and 12 exclusion criteria; among the exclusions: hyperglycemia without a known history of diabetes; H/o recent cardiac surgery (within 6 months); impaired renal function (glomerular filtration rate less than 45).

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.

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

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 2013-04 with completion listed for 2017-04.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): difference in glycemic control between treatment groups as measured by the mean daily blood glucose (time frame: Duration of hospital stay, up to 24 weeks).

It also tracked 1 secondary outcome, for example number of hypoglycemic events.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine and Insulin Lispro in 52 people.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

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