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

Tracking Information

First Received Date ^ICMJE

January 9, 2008

Last Updated Date

April 12, 2013

Start Date ^ICMJE

October 2002

Primary Completion Date

December 2002 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Prandial blood glucose lowering profile [ Time Frame: between 1st and 2nd post prandial hours ]

Change History

Complete list of historical versions of study NCT00597233 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Hypoglycaemic events [ Designated as safety issue: No ]
Adverse events [ Designated as safety issue: No ]
Serious adverse events [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Hypoglycaemic events
Adverse events
Serious adverse events

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Human Insulin NPH and Insulin Aspart in Type 1 Diabetes

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

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

Condition ^ICMJE

Diabetes
Diabetes Mellitus, Type 1

Intervention ^ICMJE

Drug: insulin aspart
Drug: soluble human insulin
Drug: insulin NPH

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2002

Primary Completion Date

December 2002 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Argentina

Administrative Information

NCT Number ^ICMJE

NCT00597233

Other Study ID Numbers ^ICMJE

ANA-1529

Has Data Monitoring Committee

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Novo Nordisk

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Adriana Sánchez, MD

Novo Nordisk Pharma Argentina S.A

Information Provided By

Novo Nordisk

Verification Date

January 2013

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

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