Glycemic Effects of Morning Only, Evening Only or Twice Daily Insulin Glargine in Patients With Type 1 Diabetes

What Was Tested

This registered not phased trial tested Insulin Glargine.

It had three arms (groups): insulin glargine only in morning (active comparator), insulin glargine only at evening (active comparator) and one (active comparator).

Morning only administration of insulin glargine.

Evening only administration of insulin glargine.

The registry classes the interventions as drug.

More on the Plan

Over the course of the 6 week study, patients will take insulin glargine in each of 3 different times: only in the morning, only at night, and half in the morning, half at night.

After 2 weeks taking the insulin in one regimen, patients will be switched to another regimen.

Through the whole study, patients will be injecting themselves twice daily, and neither the patient nor the treating doctor will know which vials contain the insulin and which have only saline (placebo).

The vials will be labeled MORNING or EVENING.

Who Took Part

Enrollment: 16 actual participants took part.

It was open to people of any sex aged from 18 years up to 90 years.

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

Examples of who could join: Adult men and women above age 18 with a diagnosis of type 1 diabetes mellitus. On multiple insulin injections, including a long acting or intermediate acting insulin preparation and mealtime short acting insulin preparation. Clinical history consistent with hypoglycemia.

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: patients with type 2 diabetes mellitus; patients on insulin pump.

How the Study Was Run

The set-up was randomized, crossover and single-blind.

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

In the crossover set-up each of the participants took both Insulin Glargine and the comparison in turn, acting as their own control.

In this single-blind Insulin Glargine study one party knew the assignments and the other did not.

Those kept unaware of assignments: investigator.

It started in 2009-07 with completion listed for 2010-03.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Time Spent (Mean Number of Minutes Per 24 Hour Day) in Hypoglycemic Range (<[amount hidden]/dl). Change in the Mean Minutes Per 24 Hour Day in the Hyperglycemic Range of > [amount hidden]/dL.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin Glargine in 16 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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