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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00569400
• Other study ID #: NN729-1541
• Status: Completed
• Phase: Phase 3
• First received: December 5, 2007
• Last updated: February 23, 2017
• Start date: May 1, 2003
• Est. completion date: January 19, 2004

Study information

• Verified date: February 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 241
• Est. completion date: January 19, 2004
• Est. primary completion date: January 19, 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• human insulin

Locations

Country	Name	City	State
Australia	Novo Nordisk Investigational Site	Broadmeadow	New South Wales
Australia	Novo Nordisk Investigational Site	Dunedin
Australia	Novo Nordisk Investigational Site	Hamilton
Australia	Novo Nordisk Investigational Site	Keswick	South Australia
Australia	Novo Nordisk Investigational Site	Kippa Ring
Australia	Novo Nordisk Investigational Site	Miranda
Australia	Novo Nordisk Investigational Site	Stones Corner
Hong Kong	Novo Nordisk Investigational Site	Shatin, New Territories
Malaysia	Novo Nordisk Investigational Site	Cheras
Malaysia	Novo Nordisk Investigational Site	Georgetown, Penang
Malaysia	Novo Nordisk Investigational Site	Kota Bharu, Kelantan
Philippines	Novo Nordisk Investigational Site	Cebu City
Philippines	Novo Nordisk Investigational Site	Iloilo
Philippines	Novo Nordisk Investigational Site	Makati City
Philippines	Novo Nordisk Investigational Site	Marikina City

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Australia,  Hong Kong,  Malaysia,  Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of human insulin antibodies		after 26 weeks of treatment
Secondary	Change of human insulin antibodies
Secondary	Frequency of adverse events

External Links

•   Clinical Trials at Novo Nordisk