Back to resultsHuman Insulin NPH and Insulin Aspart in Type 1 Diabetes
Primary Purpose
Diabetes, Diabetes Mellitus, Type 1
Status
Completed
Phase
Phase 4
Locations
Argentina
Study Type
Interventional
Intervention
insulin aspart
soluble human insulin
insulin NPH
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes
Eligibility 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)
Sites / Locations
- Novo Nordisk Investigational Site
Outcomes
Primary Outcome Measures
Prandial blood glucose lowering profile
Secondary Outcome Measures
Hypoglycaemic events
Adverse events
Serious adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00597233
Brief Title
Human Insulin NPH and Insulin Aspart in Type 1 Diabetes
Official Title
Comparative Evaluation of Human NPH Insulin + Insulin Aspart and Human NPH Insulin + Human Soluble Insulin in Type 1 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
December 2002 (Actual)
Study Completion Date
December 2002 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 1
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
91 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
insulin aspart
Intervention Type
Drug
Intervention Name(s)
soluble human insulin
Intervention Type
Drug
Intervention Name(s)
insulin NPH
Primary Outcome Measure Information:
Title
Prandial blood glucose lowering profile
Time Frame
between 1st and 2nd post prandial hours
Secondary Outcome Measure Information:
Title
Hypoglycaemic events
Title
Adverse events
Title
Serious adverse events
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Junin
Country
Argentina
12. IPD Sharing Statement
Citations:
Citation
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
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
Human Insulin NPH and Insulin Aspart in Type 1 Diabetes
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