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Observational Study to Evaluate Safety and Efficacy of Insulin Therapy in Type 2 Diabetes Mellitus Subjects Failing on Oral Anti-diabetic Agents

NCT ID: NCT00715780

Last Updated: 2016-11-07

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

1667 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-06-30

Study Completion Date

2009-07-31

Brief Summary

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This study is conducted in Asia. The aim of this observational study is to evaluate the incidence of major hypoglycaemic episodes and other adverse events, and to evaluate efficacy while using insulin under normal clinical practice conditions. The switch from OAD treatment to insulin therapy will be determined by physician.

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

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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A

soluble human insulin

Intervention Type DRUG

Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

biphasic human insulin

Intervention Type DRUG

Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

insulin NPH

Intervention Type DRUG

Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

insulin aspart

Intervention Type DRUG

Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

biphasic insulin aspart

Intervention Type DRUG

Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

insulin detemir

Intervention Type DRUG

Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

Interventions

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soluble human insulin

Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

Intervention Type DRUG

biphasic human insulin

Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

Intervention Type DRUG

insulin NPH

Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

Intervention Type DRUG

insulin aspart

Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

Intervention Type DRUG

biphasic insulin aspart

Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

Intervention Type DRUG

insulin detemir

Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

Intervention Type DRUG

Other Intervention Names

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Actrapid®

Eligibility Criteria

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Inclusion Criteria

* Type 2 diabetes for at least 12 months and currently receiving oral anti-diabetic (OAD) treatment, whether single or combination, for at least 3 months before this study
* Insulin naive
* Poor glycaemic control on OADs and decided by the physician to start insulin therapy

Exclusion Criteria

* Type 1 diabetes patients
* Patients who are unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for the final visit
* Patients with a hypersensitivity to insulin or to any of the excipients
* Patient groups not approved in the product label
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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Novo Nordisk Investigational Site

Jakarta, , Indonesia

Site Status

Countries

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Indonesia

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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INS-3615

Identifier Type: -

Identifier Source: org_study_id