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Human Insulin NPH and Insulin Aspart in Type 1 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00597233
First received: January 9, 2008
Last updated: April 12, 2013
Last verified: January 2013

January 9, 2008
April 12, 2013
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 ] [ Designated as safety issue: No ]
Prandial blood glucose lowering profile [ Time Frame: between 1st and 2nd post prandial hours ]
Complete list of historical versions of study NCT00597233 on ClinicalTrials.gov Archive Site
  • Hypoglycaemic events [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: No ]
  • Serious adverse events [ Designated as safety issue: No ]
  • Hypoglycaemic events
  • Adverse events
  • Serious adverse events
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
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 1
  • Drug: insulin aspart
  • Drug: soluble human insulin
  • Drug: insulin NPH
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
91
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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Argentina
 
NCT00597233
ANA-1529
No
Not Provided
Novo Nordisk A/S
Not Provided
Study Director: Adriana Sánchez, MD Novo Nordisk Pharma Argentina S.A
Novo Nordisk A/S
January 2013

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