Human Insulin NPH and Insulin Aspart in Type 1 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00597233
Recruitment Status : Completed
First Posted : January 18, 2008
Last Update Posted : December 22, 2016
Information provided by (Responsible Party):
Novo Nordisk A/S

January 9, 2008
January 18, 2008
December 22, 2016
October 2002
December 2002   (Final data collection date for primary outcome measure)
Prandial blood glucose lowering profile [ Time Frame: between 1st and 2nd post prandial hours ]
Same as current
Complete list of historical versions of study NCT00597233 on Archive Site
  • Hypoglycaemic events
  • Adverse events
  • Serious adverse events
Same as current
Not Provided
Not Provided
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
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.
Not Provided
Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 1
  • Drug: insulin aspart
  • Drug: soluble human insulin
  • Drug: insulin NPH
Not Provided
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 2004; 38 (4): 218-224

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2002
December 2002   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP