Comparison of Biphasic Insulin Aspart 70/30 Versus Insulin Glargine in Subjects With Type 2 Diabetes

NCT ID: NCT00097877

Last Updated: 2017-01-11

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

293 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2006-11-30

Brief Summary

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This trial is conducted in the United States of America (USA). The purpose of this study is to test whether Biphasic Insulin Aspart 70/30 twice a day with Metformin improves glycemic control vs. once daily Insulin Glargine with Metformin in subjects with Type 2 Diabetes who are inadequately controlled on basal insulin plus oral anti-diabetic 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

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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biphasic insulin aspart

Intervention Type DRUG

insulin glargine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Type 2 Diabetes
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

Birmingham, Alabama, United States

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Tuscaloosa, Alabama, United States

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Vestavia Hills, Alabama, United States

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Searcy, Arkansas, United States

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Chula Vista, California, United States

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Fullerton, California, United States

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Orange, California, United States

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Orange, California, United States

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New Britain, Connecticut, United States

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Aventura, Florida, United States

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Chiefland, Florida, United States

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Fort Myers, Florida, United States

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Jacksonville, Florida, United States

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Melbourne, Florida, United States

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Ocala, Florida, United States

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Plantation, Florida, United States

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Atlanta, Georgia, United States

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Atlanta, Georgia, United States

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Boise, Idaho, United States

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Chicago, Illinois, United States

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New Albany, Indiana, United States

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Des Moines, Iowa, United States

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Overland Park, Kansas, United States

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Topeka, Kansas, United States

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Baton Rouge, Louisiana, United States

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Baltimore, Maryland, United States

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Springfield, Massachusetts, United States

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Chesterfield, Missouri, United States

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St Louis, Missouri, United States

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St Louis, Missouri, United States

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Omaha, Nebraska, United States

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Las Vegas, Nevada, United States

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Cherry Hill, New Jersey, United States

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Lawrenceville, New Jersey, United States

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Plainsboro, New Jersey, United States

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New Hyde Park, New York, United States

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Staten Island, New York, United States

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Syracuse, New York, United States

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Greensboro, North Carolina, United States

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Dayton, Ohio, United States

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Dayton, Ohio, United States

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Kettering, Ohio, United States

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Clinton, Oklahoma, United States

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Tulsa, Oklahoma, United States

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Eugene, Oregon, United States

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Portland, Oregon, United States

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Salem, Oregon, United States

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Lancaster, Pennsylvania, United States

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Melrose Park, Pennsylvania, United States

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Norristown, Pennsylvania, United States

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West Reading, Pennsylvania, United States

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Greer, South Carolina, United States

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Memphis, Tennessee, United States

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Arlington, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Lewisville, Texas, United States

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Midland, Texas, United States

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Plano, Texas, United States

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Plano, Texas, United States

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San Antonio, Texas, United States

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Ogden, Utah, United States

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Newport News, Virginia, United States

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Richmond, Virginia, United States

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Warrenton, Virginia, United States

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Bellevue, Washington, United States

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Milwaukee, Wisconsin, United States

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Manatí, , Puerto Rico

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Santurce, , Puerto Rico

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Countries

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United States Puerto Rico

References

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Ligthelm RJ, Gylvin T, DeLuzio T, Raskin P. A comparison of twice-daily biphasic insulin aspart 70/30 and once-daily insulin glargine in persons with type 2 diabetes mellitus inadequately controlled on basal insulin and oral therapy: a randomized, open-label study. Endocr Pract. 2011 Jan-Feb;17(1):41-50. doi: 10.4158/EP10079.OR.

Reference Type RESULT
PMID: 20713345 (View on PubMed)

Oyer DS, Shepherd MD, Coulter FC, Bhargava A, Deluzio AJ, Chu PL, Trippe BS; Initiateplus Study Group. Efficacy and tolerability of self-titrated biphasic insulin aspart 70/30 in patients aged >65 years with type 2 diabetes: an exploratory post hoc subanalysis of the INITIATEplus trial. Clin Ther. 2011 Jul;33(7):874-83. doi: 10.1016/j.clinthera.2011.05.093. Epub 2011 Jul 8.

Reference Type RESULT
PMID: 21741089 (View on PubMed)

Trippe BS, Shepherd MD, Coulter FC, Bhargava A, Brett J, Chu PL, Oyer DS. Efficacy and safety of biphasic insulin aspart 70/30 in type 2 diabetes patients of different race or ethnicity (INITIATEplus trial). Curr Med Res Opin. 2012 Jul;28(7):1203-11. doi: 10.1185/03007995.2012.686444. Epub 2012 Jun 25.

Reference Type RESULT
PMID: 22509859 (View on PubMed)

Bergenstal R, Lewin A, Bailey T, Chang D, Gylvin T, Roberts V; NovoLog Mix-vs.-Exenatide Study Group. Efficacy and safety of biphasic insulin aspart 70/30 versus exenatide in subjects with type 2 diabetes failing to achieve glycemic control with metformin and a sulfonylurea. Curr Med Res Opin. 2009 Jan;25(1):65-75. doi: 10.1185/03007990802597951.

Reference Type DERIVED
PMID: 19210140 (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-2191

Identifier Type: -

Identifier Source: org_study_id

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