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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
ClinicalTrials.gov Identifier:
NCT00597233
First received: January 9, 2008
Last updated: April 12, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 1
 Drug: insulin aspart
Drug: soluble human insulin
Drug: insulin NPH
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparative Evaluation of Human NPH Insulin + Insulin Aspart and Human NPH Insulin + Human Soluble Insulin in Type 1 Diabetes Mellitus

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • Prandial blood glucose lowering profile [ Time Frame: between 1st and 2nd post prandial hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hypoglycaemic events [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: No ]
  • Serious adverse events [ Designated as safety issue: No ]

Enrollment: 91
Study Start Date: October 2002
Study Completion Date: December 2002
Primary Completion Date: December 2002 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00597233

Locations
Argentina
Junin, Argentina
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Adriana Sánchez, MD Novo Nordisk Pharma Argentina S.A
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00597233     History of Changes
Other Study ID Numbers: ANA-1529
Study First Received: January 9, 2008
Last Updated: April 12, 2013
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
 Insulin aspart
Insulin
Insulin, NPH
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013