NCT00604656|CompletedPhase 3

Comparison of Insulin Aspart Produced by the NN2000 Process to the Current Process in Type 1 Diabetes

A Six Months, Multi-centre, Open, Randomised, Parallel Safety and Efficacy Comparison of NovoRapid® Produced by the Current Process and Insulin Aspart With the Same Formulation as NovoRapid®, Produced by the NN2000 Process in Subjects With Type 1 Diabetes on a Basal/Bolus Regimen

Novo Nordisk A/S ClinicalTrials.gov

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1 other identifier

NN2000-1542

Study Type

interventional

Target

241

Locations

5 countries

Sites

Timeline

RegisteredJan 2008

StartedMay 2003

CompletionJan 2004

Brief Summary

This trial is conducted in Europe. The aim of this trial is to investigate the safety and efficacy of insulin aspart produced by current process compared to that of insulin aspart produced by NN2000 process in subjects with type 2 diabetes.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

241

participants targeted

Target at P25-P50 for phase_3 diabetes

Timeline

Completed

Started May 2003

Shorter than P25 for phase_3 diabetes

Geographic Reach

5 countries

34 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

9 months study duration

Study Start

First participant enrolled

May 5, 2003

Completed

9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 29, 2004

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 29, 2004

Completed

4 years until next milestone

First Submitted

Initial submission to the registry

January 17, 2008

Completed

13 days until next milestone

First Posted

Study publicly available on registry

January 30, 2008

Completed

Last Updated

March 1, 2017

Status Verified

February 1, 2017

Enrollment Period

9 months

First QC Date

January 17, 2008

Last Update Submit

February 28, 2017

Conditions

Diabetes Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

Insulin aspart antibodies
After 6 months treatment

Secondary Outcomes (3)

Occurrence of adverse events
Incidence of hypoglycaemic episodes
HbA1c

Interventions

insulin aspartDRUG

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Subjects with type 1 diabetes
Duration of diabetes for at least 12 months
Treatment with insulin aspart for at least 3 months before trial start
Body Mass Index (BMI) below 35.0 kg/m2
HbA1c below 12.0%

You may not qualify if:

Total insulin dosage more than 1.4 IU/kg/day
Recurrent major hypoglycaemia that may interfere with trial participation (as judged by the investigator)
Known hypoglycaemia unawareness as judged by the investigator
Known hypersensitivity or allergy

Contact the study team to confirm eligibility.