Safety and Efficacy of Insulin Detemir in Combination With OADs in Type 2 Diabetes

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

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2004-12-31

Brief Summary

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This trial is conducted in Asia.

The aim of this trial is to evaluate the blood glucose achieved with insulin detemir as add-on to current oral antidiabetic drug (OAD) treatment in subjects with type 2 diabetes.

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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

Interventions

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insulin detemir

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Type 2 diabetes for at least 12 months since diagnosis
* Insulin naive subjects
* OAD treatment for at least 4 months with max. two OAD treatments
* Body mass index below 30.0 kg/m2
* HbA1c between 7.0-11.0%

Exclusion Criteria

* OAD treatment with three or more OADs
* Secondary diabetes
* Known hypoglycaemia unawareness or recurrent major hypoglycaemia as judged by the Investigator
* Uncontrolled hypertension
* Known or suspected allergy to trial product or related products

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No