Detemir: Role in Type 1 Diabetes

What Was Tested

This registered phase 4 trial tested Insulin Detemir.

Study of blood sugars in the children with Type 1 Diabetes Mellitus (T1DM), who are given insulin detemir and a rapid acting insulin (aspart).

It had two arms (groups): Insulin Detemir+RAI, then Insulin Detemir and RAI separately (experimental) and Insulin Detemir and RAI separately, then Insulin Detemir+RAI (active comparator).

Participants first received, Insulin Detemir mixed with RAI, twice daily as subcutaneous injection for 10 days. Then they received Insulin Detemir and RAI as separate subcutaneous injections, twice daily for the next 10 days.

Participants first received Insulin Detemir and RAI as separate subcutaneous injections, twice daily for 10 days. Then they received Insulin Detemir mixed with RAI, twice daily as subcutaneous injection for the next 10 days.

The registry classes the interventions as drug.

More on the Plan

One of the barriers to good glycemic control in children with type 1 diabetes is multiple daily insulin injections.

Eighteen pediatric subjects with type 1 diabetes (11 males and 7 females) were recruited.

However only 14 subjects completed this 20-day, randomized, crossover, and open-labeled study.

The subjects were randomly assigned to either Study A (both insulin detemir and rapid acting insulin (RAI)) or Study B (either detemir or aspart) for the first 10 days.

Who Took Part

Enrollment: 18 actual participants took part.

It was open to people of any sex aged from 10 years up to 25 years.

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

Examples of who could join: Subjects with antibody positive Type 1 Diabetes Mellitus (T1DM). On insulin glargine for at least 3 months. Age 10-25 years. Not on medications that may affect glucose concentrations. Body Mass Index (BMI) less than 95th % and more than 10th%.

The full record lists 7 inclusion and 3 exclusion criteria; among the exclusions: subjects with undetermined diabetes or type 2 diabetes mellitus (t2dm); unable to adhere to insulin regimen; positive urine pregnancy test.

How the Study Was Run

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

The participants were allocated by chance, so the Insulin Detemir group and the comparison group should start out alike.

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

Everyone knew when Insulin Detemir was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2007-08 with completion listed for 2009-12.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Assess the Mean Area Under the Curve (AUC) for Blood Glucose Concentration in Subjects Treated With Either Insulin Detemir Mixed With Rapid Acting Insulin (RAI) or Insulin Detemir and RAI as Separate Subcutaneous Injections.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Detemir in 18 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 Detemir compound page, all human trials.