Comparison Study of Insulin Glargine and NPH Insulin

What Was Tested

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

It had two arms (groups): Switching to NPH insulin (experimental) and Continuation of insulin glargine (active comparator).

Patients in this arm will be transitioned from insulin glargine to NPH insulin with subsequent titration according to algorithm within protocol. If needed, meal-time insulin will be added during study period.

Patients in this arm will continue on insulin glargine and serve as a control group.

The registry classes the interventions as drug.

More on the Plan

In this study the investigators will be comparing two long-acting insulins, insulin glargine and NPH insulin.

Who Took Part

It was open to people of any sex aged up to 85 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Diagnosis of type 2 diabetes mellitus.

The full record lists 4 inclusion and 12 exclusion criteria; among the exclusions: diagnosis of type 1 diabetes mellitus; age \> 85 years; self-reported history of severe hypoglycemia or hypoglycemia unawareness.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Insulin Glargine and who got the comparison, which limits bias.

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

Being open-label, the Insulin Glargine study did not mask who received what.

It started in 2013-04 with completion listed for 2015-12.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Difference in A1C between groups at 6 months (time frame: 6 months).

It also tracked 11 secondary outcomes, for example Difference in A1C between groups at 3 months, Difference in self-monitored blood glucose averages between groups, Difference in incidence of hypoglycemia between each group, Difference in units of basal insulin used per day between groups, Difference in total units of insulin per day between groups and Difference in percent of patients who require initiation/titration of prandial insulin between each group.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine and NPH Insulin (isophane) in people.

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

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