Insulin Glargine at Bedtime or in AM Versus NPH

What Was Tested

This registered phase 4 trial tested Insulin Glargine and NPH Insulin (isophane).

It had three arms (groups): 1 - Insulin glargine QHS (experimental), 2 - Insulin glargine QAM (experimental) and 3 - NPH Insulin QHS (active comparator).

Insulin glargine injected subcutaneously once daily at bedtime.

Insulin glargine injected subcutaneously once daily in the morning.

NPH insulin injected subcutaneously once daily at bedtime.

The registry classes the interventions as drug.

More on the Plan

Inner city ethnic minority patients with diabetes are a particularly challenging population of diabetic patients to treat.

Who Took Part

Enrollment: 108 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Male or female, age 18-75. Type 2 diabetes diagnosed for at least 1 year. No past history of chronic insulin use (other than treatment of gestational diabetes or hospitalizations of less than 1 week in duration). Body mass index (BMI) between 20 and 40 kg/m2.

The full record lists 7 inclusion and 11 exclusion criteria; among the exclusions: current or previous chronic use of insulin (other than for treatment of gestational diabetes); history of confirmed (or clinical suspicion of) type 1 diabetes; female subjects of childbearing potential who are sexually active and not using a reliable form of contraception.

How the Study Was Run

The set-up was 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.

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

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

It started in 2003-02 with completion listed for 2009-08.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Hemoglobin A1c Change From Baseline (time frame: Baseline to 6 months).

It also tracked 6 secondary outcomes, for example Frequency of Total Hypoglycemic Reactions, Frequency of Severe Hypoglycemic Reactions, Body Mass Index Change From Baseline and Any Adverse Event Other Than Hypoglycemia.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine and NPH Insulin (isophane) in 108 people.

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

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