Observational Study of Patients Using NovoRapid® or Soluble Human Insulin for Treatment of Type 2 Diabetes

NCT ID: NCT00698126

Last Updated: 2016-10-28

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

Total Enrollment

4099 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-10-31

Study Completion Date

2009-05-31

Brief Summary

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This trial is conducted in Europe. The aim of this observational study is to evaluate the incidence of major hypoglycaemic episodes in patients with type 2 diabetes treated with NovoRapid® or Soluble Human Insulin under normal clinical practice conditions.

Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 2

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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A

soluble human insulin

Intervention Type DRUG

Observational study; use of the products as in the normal clinical practice conditions

B

biphasic insulin aspart

Intervention Type DRUG

Observational study; use of the products as in the normal clinical practice conditions

Interventions

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soluble human insulin

Observational study; use of the products as in the normal clinical practice conditions

Intervention Type DRUG

biphasic insulin aspart

Observational study; use of the products as in the normal clinical practice conditions

Intervention Type DRUG

Other Intervention Names

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Actrapid

Eligibility Criteria

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Inclusion Criteria

* Patients with type 2 diabetes
* Treatment with Insulin Aspart (NovoRapid®) or Soluble Human Insulin for minimum 3 months and maximum 3 years

Exclusion Criteria

* Patients with an end-stage renal failure
* Patients with a serious liver disease
* Patients with concomitant malignant disease
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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Novo Nordisk Investigational Site

Rome, , Italy

Site Status

Countries

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Italy

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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ANA-1897

Identifier Type: -

Identifier Source: org_study_id