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

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)