Safety of Insulin Detemir for the Treatment of Insulin Dependent Type 1 or Type 2 Diabetes Mellitus

Novo Nordisk A/S2,287 enrolled

Overview

This trial is conducted in North America. The aim of this trial is to evaluate the safety of insulin detemir for the treatment of diabetes.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

2,287

Conditions

Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2

Interventions

insulin detemirDRUG

Administered subcutaneously (s.c., under the skin). Dose individually adjusted.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosed with type 1 or type 2 diabetes * Using a basal/bolus insulin regimen Exclusion Criteria: * Subjects who are unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for the final visit * Subjects who previously enrolled in this study * Subjects with a hypersensitivity to insulin detemir or to any of the excipients

Locations (1)

Unnamed facility

Mississauga, Canada

Outcomes

Primary Outcomes

Incidence of serious adverse drug reactions (SADRs) including major hypoglycaemic events

Secondary Outcomes

Number of adverse events (all and serious)

Number of all hypoglycaemic events

Change in weight

HbA1c (glycosylated haemoglobin)

Treatment satisfaction as assessed by Insulin Treatment Satisfaction Questionnaire (ITSQ-22)

Data from ClinicalTrials.gov

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