Efficacy of Biphasic Insulin Aspart 30 in Type 2 Diabetics Failing on OADs

NCT ID: NCT00791895

Last Updated: 2017-02-24

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

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-26

Study Completion Date

2004-11-29

Brief Summary

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This trial is conducted in the United States of America (USA). The aim of this trial is to investigate the effectiveness of biphasic insulin aspart 30 in type 2 diabetics not achieving blood sugar levels when treated with oral anti-diabetics drugs (OADs) with or without basal insulin therapy.

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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A

Group Type EXPERIMENTAL

biphasic insulin aspart 30

Intervention Type DRUG

Treat-to-target dose titration scheme

Interventions

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biphasic insulin aspart 30

Treat-to-target dose titration scheme

Intervention Type DRUG

Other Intervention Names

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BIASP NovoLog® Mix 70/30 NovoMix®

Eligibility Criteria

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Inclusion Criteria

* Type 2 diabetes mellitus for at least 12 months
* HbA1c: 7.5-10.0%
* An antidiabetic regimen that has been stable for at least 3 months
* Able and willing to perform SMBG testing as per protocol

Exclusion Criteria

* Use of any insulin preparations other than NPH or glargine within the past 6 months
* Pregnancy, breastfeeding, intention to become pregnant within the next 12 months, or judged to be using inadequate contraceptive measures (adequate contraceptive measures includes: sterilization, intrauterine devices, oral contraceptives, or consistent use of barrier methods)
* Known or suspected allergy to trial product or agents related to trial product
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

Phoenix, Arizona, United States

Site Status

Novo Nordisk Investigational Site

La Jolla, California, United States

Site Status

Novo Nordisk Investigational Site

La Jolla, California, United States

Site Status

Novo Nordisk Investigational Site

DeLand, Florida, United States

Site Status

Novo Nordisk Investigational Site

Wichita, Kansas, United States

Site Status

Novo Nordisk Investigational Site

Omaha, Nebraska, United States

Site Status

Novo Nordisk Investigational Site

Albany, New York, United States

Site Status

Novo Nordisk Investigational Site

Cleveland, Ohio, United States

Site Status

Novo Nordisk Investigational Site

Medford, Oregon, United States

Site Status

Novo Nordisk Investigational Site

Memphis, Tennessee, United States

Site Status

Novo Nordisk Investigational Site

Dallas, Texas, United States

Site Status

Novo Nordisk Investigational Site

Houston, Texas, United States

Site Status

Novo Nordisk Investigational Site

Ogden, Utah, United States

Site Status

Novo Nordisk Investigational Site

Renton, Washington, United States

Site Status

Novo Nordisk Investigational Site

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

References

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Garber AJ, Wahlen J, Wahl T, Bressler P, Braceras R, Allen E, Jain R. Attainment of glycaemic goals in type 2 diabetes with once-, twice-, or thrice-daily dosing with biphasic insulin aspart 70/30 (The 1-2-3 study). Diabetes Obes Metab. 2006 Jan;8(1):58-66. doi: 10.1111/j.1463-1326.2005.00563.x.

Reference Type RESULT
PMID: 16367883 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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BIASP-2174

Identifier Type: -

Identifier Source: org_study_id

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