The Incidence of Hypoglycemia in Insulin Glargine-Treated Subjects With Diabetes Mellitus Upon Switching Between Bedtime and Morning Dosing

What Was Tested

This registered phase 4 trial tested Insulin Glargine.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 22 actual participants took part.

It was open to people of any sex aged from 6 years up to 75 years.

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

Examples of who could join: Ability and willingness to perform blood glucose profiles using a plasma glucose meter provided at home over 11 consecutive days.

The full record lists 6 inclusion and 11 exclusion criteria; among the exclusions: use of any other intermediate- or long-acting insulin (e.g., nph, ultralenter, lenter) within the last 2 months prior to screening; likelihood of requiring treatment during the study period with drugs not permitted by the study protocol (e.g., systemic corticosteroids); history of hypoglycemia unawareness.

How the Study Was Run

Design: non-randomized, single-group and open-label.

Nothing was hidden in this open-label Insulin Glargine study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2004-01 with completion listed for 2004-08.

It ran at 1 site in Mexico.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Compare % of subjects with glucose > or = to [amount hidden]/dL at any point of 8-point glucose profiles during 3 consecutive days.

It also tracked 5 secondary outcomes, for example To compare the mean daily rate of hypoglycemia during 3 consecutive days, To compare the incidence of symptomatic hypoglycemia and To evaluate overall safety and tolerability based on adverse event reporting, laboratory tests, and clinical examinations.

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized trial of Insulin Glargine in 22 people.

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

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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