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Observational Study to Investigate the Efficacy and Safety of Human Insulin or Insulin Analogue Treatments in Type 2 Diabetes Subjects

NCT ID: NCT00806936

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

4847 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-12-31

Study Completion Date

2009-12-31

Brief Summary

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This study is conducted in Asia. The aim of this observational study is to investigate the percentage of patients reaching the treatment target on blood glucose control after treatment with either human insulin or insulin analogues in type 2 diabetes subjects inadequately controlled with two or more oral antidiabetic drugs in China. Further the safety profiles will be evaluated.

Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 2

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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A

human insulin

Intervention Type DRUG

Any kind of human insulin administered at the discretion of the physician

B

insulin analogue

Intervention Type DRUG

Any kind of insulin analogue administered at the discretion of the physician

Interventions

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human insulin

Any kind of human insulin administered at the discretion of the physician

Intervention Type DRUG

insulin analogue

Any kind of insulin analogue administered at the discretion of the physician

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* After the investigator has taken the decision to use human insulin or insulin analogues to treat the subject, any type 2 diabetic previously inadequately controlled with two or more OADs is eligible for the study
* The selection of the subjects will be at the discretion of the individual investigator

Exclusion Criteria

* Known or suspected allergy to trial product(s) or related products
* Subjects who are unlikely to comply with protocol requirements, e.g. uncooperative attitude, inability to return for the final visit
* Subjects who previously enrolled in this study
* Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods
* The receipt of any investigational product within 3 months prior to this trial
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

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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INS-3675

Identifier Type: -

Identifier Source: org_study_id