Effect of Biphasic Insulin Aspart 30 Combined With Metformin on Blood Glucose Control in Subjects With Type 2 Diabetes Inadequately Controlled With Basal Insulin

NCT ID: NCT00669864

Last Updated: 2016-04-01

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

293 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2009-04-30

Brief Summary

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This trial is conducted in Asia. This single arm trial aims to evaluate the blood glucose control with twice daily biphasic insulin aspart 30 in combination with metformin in Chinese subjects with type 2 diabetes inadequately controlled with once or twice daily basal insulin.

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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BIAsp 30-30

Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 1000-2000mg, up to three times daily

Group Type EXPERIMENTAL

biphasic insulin aspart 30

Intervention Type DRUG

Subcutaneous (under the skin) injection, twice daily

metformin

Intervention Type DRUG

Tablets, 1000 - 2000 mg daily

Interventions

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biphasic insulin aspart 30

Subcutaneous (under the skin) injection, twice daily

Intervention Type DRUG

metformin

Tablets, 1000 - 2000 mg daily

Intervention Type DRUG

Other Intervention Names

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NovoMix® 30

Eligibility Criteria

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Inclusion Criteria

* Type 2 diabetes
* Currently treated with basal insulin once or twice daily with or without oral anti-diabetic drugs (OADs) for at least 3 months
* HbA1c (glycosylated haemoglobin A1c) within the range of 7.5% to10.0% ( both inclusive)
* BMI (Body Mass Index) maximum 40 kg/m2

Exclusion Criteria

* Metformin contraindications according to local practice
* Systemically treated with TZDs (thiazolidinediones) for more than one month within 6 months prior to this trial
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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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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BIASP-1960

Identifier Type: -

Identifier Source: org_study_id

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