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

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Novo Nordisk

Status and phase

Completed
Phase 3

Conditions

Diabetes Mellitus, Type 1
Diabetes

Treatments

Drug: insulin aspart

Study type

Interventional

Funder types

Industry

Identifiers

NCT00604656
NN2000-1542

Details and patient eligibility

About

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.

Enrollment

241 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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%

Exclusion criteria

  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

34

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Data sourced from clinicaltrials.gov

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