Evaluation of the Glycaemic Control With Insulin Detemir as an add-on to Current Oral Anti-diabetic Drug Treatment in Subjects With Type 2 Diabetes in Korea

NCT ID: NCT00455858

Last Updated: 2024-02-01

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2008-10-31

Brief Summary

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This trial is conducted in Asia. This trial aims for evaluating the glycaemic control, measured as glycosylated haemoglobin (Hb1Ac), of once daily insulin detemir as an add-on to oral antidiabetic drug (OAD) in subjects with type 2 diabetes mellitus in Korea.

Detailed Description

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Conditions

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Diabetes 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 ACTIVE_COMPARATOR

insulin detemir

Intervention Type DRUG

Treat-to-target dose titration scheme, once daily, injected s.c. (under the skin).

Interventions

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insulin detemir

Treat-to-target dose titration scheme, once daily, injected s.c. (under the skin).

Intervention Type DRUG

Other Intervention Names

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Levemir®

Eligibility Criteria

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Inclusion Criteria

* Type 2 diabetes (diagnosed more than 12 months ago)
* HbA1c greater than 7.0 and less than 12.0% at screening
* Currently on any OAD in more than 3 months ago
* BMI (Body Mass Index) less than 35kg/m2

Exclusion Criteria

* Previous treatment with insulin in more than 7 days within the last 3 months
* Uncontrolled treated/untreated hypertension (systolic blood pressure greater than 180mmHg and/or diastolic blood pressure less than 110mmHg)
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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Seoul, , South Korea

Site Status

Countries

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South Korea

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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NN304-1762

Identifier Type: -

Identifier Source: org_study_id

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