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

NCT ID: NCT01709929

Last Updated: 2016-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2287 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2006-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Insulin detemir

Group Type EXPERIMENTAL

insulin detemir

Intervention Type DRUG

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

Interventions

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insulin detemir

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Mississauga, , Canada

Site Status

Countries

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Canada

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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NN304-1713

Identifier Type: -

Identifier Source: org_study_id

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