Comparison of Lantus and Neutral Protamine Hagedorn (NPH) Insulin in the Dawn Phenomenon

What Was Tested

This registered phase 3 trial tested Insulin Glargine.

To investigate the effect of insulin glargine (Lantus™) vs NPH insulin regarding glycemic control during the early AM (dawn phenomenon) in individuals with type 1 diabetes. 2.

To measure hormones implicated in the pathogenesis of the dawn phenomenon in individuals with type 1 diabetes.

It had two arms (groups): Glargine (Lantus) insulin (active comparator) and NPH insulin (active comparator).

The registry classes the interventions as drug.

More on the Plan

Title: COMPARISON of LANTUS and NPH INSULIN IN THE DAWN PHENOMENON I.

For individuals with type 1 diabetes, the challenge has been to replicate insulin secretion of the healthy pancreas to maintain blood glucose as close to the non-diabetic range as possible.

Insulin regimes using insulins with varied activity profiles (multiple daily injections or MDI) and continuous subcutaneous insulin infusion (CSII) have been somewhat successful in "mimicking" normal pancreatic function (1, 2).

Insulin analogs that provide more stable physiologic insulin levels have led to the development of newer MDI regimes (5).

Who Took Part

27 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Written informed consent obtained prior to performing screening evaluations. Male or female, 18 yrs or older. Diagnosis of type 1 diabetes made 5 years prior to screening visit. Body Mass Index (BMI) 35 kg/m2 at screening visit. Documented undetectable C-Peptide.

The full record lists 8 inclusion and 10 exclusion criteria; among the exclusions: type 2 diabetes; two or more severe hypoglycemic episodes (requiring assistance) within six months of screening; history of allergy or intolerance to nph or glargine.

How the Study Was Run

It was run as a non-randomized, crossover and open-label study.

Each person switched between Insulin Glargine and the comparison at some point, usually with a gap in between.

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 2005-06 with completion listed for 2010-11.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Blood Glucose Area Under the Curve (AUC) (time frame: Overnight). Blood Glucose (time frame: Overnight).

It also tracked 4 secondary outcomes, for example Cortisol, Glucagon and Growth Hormone.

What This Means in Plain Language

Put simply, this is a phase 3, non-randomized trial of Insulin Glargine in 27 people.

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

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, all human trials.