Human Insulin NPH and Insulin Aspart in Type 1 Diabetes

Comparative Evaluation of Human NPH Insulin + Insulin Aspart and Human NPH Insulin + Human Soluble Insulin in Type 1 Diabetes Mellitus

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00597233

Enrollment

Registered

2008-01-18

Start date

2002-10-31

Completion date

2002-12-31

Last updated

2016-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Diabetes Mellitus, Type 1

Brief summary

This trial is conducted in South America. This aim of this trial is to evaluate the comparative prandial blood glucose lowering profile in subjects with type 1 diabetes.

Interventions

DRUGinsulin aspart

DRUGsoluble human insulin

DRUGinsulin NPH

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Type 1 diabetes for at least 12 months * Treatment with insulin NPH * Body Mass Index (BMI) below 30 kg/m2

Exclusion criteria

* Total daily insulin dose greater than 1.40 IU/kg * Treatment with oral antidiabetic drugs (OADs)

Design outcomes

Primary

Measure	Time frame
Prandial blood glucose lowering profile	between 1st and 2nd post prandial hours

Secondary

Measure	Time frame
Hypoglycaemic events	—
Adverse events	—
Serious adverse events	—

Countries

Argentina

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026