Preservation of Pancreatic Beta Cell Function Through Insulin Pump Therapy

Plain-language guide to NCT00574405: not phased randomized trial of Insulin Glargine and Insulin Aspart, 24 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT00574405
Phase: not phased
Status: completed
Start: 2005-04
Completion (planned or actual): 2010-03
Participants: 24 (actual)
Design: randomized, open label (everyone knows who gets what), treatment
Conditions studied: Diabetes Mellitus
Results posted: yes

What This Study Did, in Plain Language

What Was Tested

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

It had two arms (groups): 1 (active comparator) and 2 (experimental).

MDI = 3-4+ insulin injections/day, using split-mix NPH insulin + regular insulin or Lantus + Novolog® (or Humalog®).

CSII (insulin pump), using Animas Corporation insulin pump, model IR 1200.

The registry classes the interventions as device and drug.

Who Took Part

24 actual participants took part.

It was open to people of any sex aged from 8 years up to 18 years.

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

Examples of who could join: Medical history and clinical presentation consistent with the diagnosis of Type 1 DM. Age: 8-18 years.

The full record lists 2 inclusion and 4 exclusion criteria; among the exclusions: clinical presentation consistent with type 2 dm; history of other chronic systemic inflammatory or autoimmune disease or other severe medical conditions; concurrent pregnancy.

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.

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

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

It started in 2005-04 with completion listed for 2010-03.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in Mixed-meal-stimulated Peak C-peptide Value (Via Mixed-meal Tolerance Test) After 12 Months of Insulin Pump Therapy, Compared With MDI (time frame: 12 months).

It also tracked 4 secondary outcomes, for example Changes in Daily Insulin Requirements Over Time, Frequency of Adverse Glycemic Consequences, i.e., Frequency of Hypoglycemia, Severe Hyperglycemia or Ketosis and Patient Satisfaction With Mode of Therapy and Patient Compliance With Treatment Recommendations.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin Glargine and Insulin Aspart in 24 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 and the Insulin Aspart compound page, all human trials.

Our Notes on the Compounds

Insulin Glargine: A long-acting insulin analog given once daily; brands include Lantus, Toujeo, Basaglar and Semglee.

Insulin Aspart: A rapid-acting mealtime insulin analog; brands include NovoLog, NovoRapid and Fiasp.

Insulin Lispro: A rapid-acting mealtime insulin analog; brands include Humalog, Admelog and Lyumjev.

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.