Human Insulin NPH and Insulin Aspart in Type 1 Diabetes

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00597233
• Other study ID #: ANA-1529
• Status: Completed
• Phase: Phase 4
• First received: January 9, 2008
• Last updated: December 20, 2016
• Start date: October 2002
• Est. completion date: December 2002

Study information

• Verified date: December 2016
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: December 2002
• Est. primary completion date: December 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• insulin aspart

• soluble human insulin

• insulin NPH

Locations

Country	Name	City	State
Argentina	Novo Nordisk Investigational Site	Junin

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Argentina, 

References & Publications (1)

Cintora H, Rodrigues M, Klyver MI, Claus-Hermerg H, González G, Kanevsky D, Medrano G, Sánchez A. Insulina Aspártica versus insulina soluble humana: Estudio comparativo cruzado en pacientes con diabetes tipo 1. Revista de la Sociedad Argentina de Diabetes

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prandial blood glucose lowering profile		between 1st and 2nd post prandial hours	No
Secondary	Hypoglycaemic events			No
Secondary	Adverse events			No
Secondary	Serious adverse events			No

External Links

•   Clinical Trials at Novo Nordisk