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

Novo Nordisk A/S241 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

241

Conditions

Diabetes Diabetes Mellitus, Type 1

Interventions

insulin aspartDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (34)

Outcomes

Primary Outcomes

Insulin aspart antibodies

Time frame: After 6 months treatment

Secondary Outcomes

Occurrence of adverse events

Incidence of hypoglycaemic episodes

HbA1c

Data from ClinicalTrials.gov

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