Efficacy and Safety of a Fixed or a Flexible Supplementary Insulin Therapy 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

PHASE4

Total Enrollment

373 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2006-11-30

Brief Summary

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This trial is conducted in Europe. This trial aims for a comparison of the efficacy and safety of Insulin Aspart, given in a fixed or in a flexible supplementary insulin therapy, with or without Insulin Detemir plus Metformin, if needed, in subjects with type 2 diabetes.

Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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insulin detemir

Intervention Type DRUG

insulin aspart

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Type 2 Diabetes for more than 6 months
* Treatment with 1 or more oral anti-diabetic drugs or insulin, or a combination of these for more than 3 months
* Body Mass Index (BMI) less than or equal to 40 kg/m2
* HbA1c 7.0-11.0%

Exclusion Criteria

* Treatment with short acting insulin(s) for longer than 10 days
* Current treatment with TZDs. A TZD medication must be stopped at least 14 days before the randomization
* Proliferative retinopathy or maculopathy requiring acute or laser treatment within the last 6 months

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

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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Düsseldorf, , Germany

Site Status

Countries

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Germany

Other Identifiers

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2005-000319-87

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NN304-1657

Identifier Type: -

Identifier Source: org_study_id