Evaluation of Pharmacokinetics and Pharmacodynamic Properties of Rapid-Acting Insulin Analogs

What Was Tested

The trial (phase 1) is built around Insulin Glargine and Insulin Lispro.

The specific factors under investigation are: * the effects of puberty * type of insulin analog * site of catheter insertion * and age of catheter.

It had four arms (groups): Catheter day 4 (active comparator), Catheter day 1 (active comparator), Aspart and Detemir (active comparator) and Lispro and Glargine (active comparator).

Adolescents with type 1 diabetes with catheters day #4.

Adolescents with type 1 diabetes with catheter day #1.

Adolescents with type 1 diabetes.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 36 actual participants took part.

It was open to people of any sex aged from 8 years up to 17 years.

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

Examples of who could join: Age 8-17 (inclusive), of whom 15 will be prepubertal and 60 pubertal;. Clinical diagnosis of T1D (based on clinical presentation, insulin dependence,and/or history of ketosis;. Diagnosis of T1D for at least one year's duration;. On CSII therapy for at least three months;. Meeting minimum weight requirement of at least 17.6 kg (for pre-pubertal subjects) or 34.6 kg (for pubertal subjects).

The full record lists 8 inclusion and 5 exclusion criteria; among the exclusions: any other medical disease aside from t1d or treated hypothyroidism; receiving any other medication besides insulin or levothyroxine; female subjects of reproductive potential who may be pregnant, breast feeding, or not consistently utilizing barrier methods or abstinence as contraception.

How the Study Was Run

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

The Insulin Glargine group and the comparison group ran side by side rather than switching.

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

It started in 2007-04 with completion listed for 2011-09.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Maximum Glucose Infusion Rate (GIR) to maintain euglycemia (time frame: Six hour observation period).

It also tracked 1 secondary outcome, for example Time to Maximum Glucose Infusion Rate.

What This Means in Plain Language

Put simply, this is a phase 1, non-randomized trial of Insulin Glargine and Insulin Lispro in 36 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 and the Insulin Lispro compound page, all human trials.