Duration of The Honeymoon Phase of Type 1 Diabetes: A Comparison of Insulins Detemir, Glargine and NPH

What Was Tested

In this not phased trial, researchers set out to test Insulin Glargine and Insulin Detemir.

To determine whether using a long-acting insulin analog at the time of diagnosis, instead of intermediate-acting insulin, affects the rate of loss of the body's ability to make insulin in children with newly diagnosed type 1 diabetes.

It had three arms (groups): Detemir (experimental), Glargine (experimental) and NPH (experimental).

24 subjects randomized to therapy with a combination of insulins detemir and aspart at diagnosis of diabetes.

24 subjects randomized to therapy with a combination of insulins glargine and aspart at diagnosis of diabetes.

24 subjects randomized to therapy with a combination of insulins NPH and aspart at diagnosis of diabetes.

The registry classes the interventions as drug.

More on the Plan

An autoimmune disorder affecting the endocrine pancreas, it causes, in the untreated state, high blood glucose levels and ketosis.

It is responsible for a disproportionate percentage of the diabetes associated retinopathy and nephropathy seen in adults with diabetes (although type 1 diabetes only accounts for a small percentage of the total populace of patients with diabetes).

Thus far nothing has proven completely successful.

Who Took Part

The registry lists 33 actual participants took part.

It was open to people of any sex aged from 6 years up to 18 years.

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

Examples of who could join: Newly diagnosed type 1 diabetes within 1 week of diagnosis. Age 6 - 18 years.

The full record lists 3 inclusion and 6 exclusion criteria; among the exclusions: actual treatment with oral drugs influencing beta cell function or blood glucose levels (e.g. oral hypoglycemic agents); actual treatment with drugs influencing insulin sensitivity (e.g. metformin, or systemic steroids); expected poor compliance.

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.

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

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

It started in 2006-09 with completion listed for 2009-02.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: C-peptide Area Under the Curve.

It also tracked 1 secondary outcome, for example Glycemic Control as Determined by HgbA1c Values at 6 Months After Diagnosis.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin Glargine and Insulin Detemir in 33 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 and the Insulin Detemir compound page, all human trials.