Comparison of Efficacy and Safety of Human Insulin Produced by the Current Process and the NN729 Process in Type 1 Diabetes Mellitus

Novo Nordisk A/S1 site in 1 country241 target enrollmentMay 1, 2003

ConditionsDiabetes Diabetes Mellitus, Type 1

Drugshuman insulin

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Diabetes
Sponsor: Novo Nordisk A/S
Enrollment: 241
Locations: 1
Primary Endpoint: Change of human insulin antibodies
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This trial is conducted in Asia and Oceania. The aim of this trial is to compare the efficacy and safety of human insulin produced by the current process and the NN729 process in type 1 diabetes.

Registry

clinicaltrials.gov

Start Date

May 1, 2003

End Date

January 19, 2004

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Novo Nordisk A/S

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Duration of diabetes for at least 12 months
•Basal/bolus treatment with human insulin for at least 2 months preceding trial start
•Body Mass Index (BMI) lesser than or equal to 35.0 kg/m2
•HbA1c lesser than or equal to 12.0%

Exclusion Criteria

•Proliferative retinopathy or maculopathy requiring acute treatment or laser treatment within the last 6 months
•Any condition that the investigator and/or sponsor feel would interfere with trial participation
•Known or suspected allergy against trial product or related products