Comparison of Two Pen Systems in Patients With Diabetes Treated With Insulin

Novo Nordisk A/S208 enrolled

Overview

This trial is conducted in Europe. The aim of this trial is to compare two insulin delivery pens in the everyday life setting of patients with diabetes treated with insulin.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

208

Conditions

Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Delivery Systems

Interventions

NovoPen™ 4DEVICE

NovoPen® 3DEVICE

Eligibility

Sex: ALLMin age: 9 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Type 1 or type 2 diabetes mellitus for at least 12 months * Adults at least 18 years * Children/adolescents between 9-18 years * HbA1c lesser than or equal to 11.0% Exclusion Criteria: * Known or suspected alcohol or drug abuse * Patients who are not able to read the user manual (may wear glasses if needed) * Hypoglycaemic unawareness as judged by the investigator * Visual and/or dexterity impairments as judged by the investigator

Locations (23)

Novo Nordisk Investigational Site

Vienna, Austria

Outcomes

Primary Outcomes

Evaluation of overall pen preference

Time frame: after 12 weeks of treatment

Secondary Outcomes

HbA1c

Adverse device effects

Adverse events

Data from ClinicalTrials.gov

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