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

NCT00097877 | Completed Phase 3

• 1 other identifier: BIASP-2191
• Study Type: interventional
• Target: 293
• Locations: 2 countries
• Sites: 73

Brief Summary

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.

Conditions

Diabetes; Diabetes Mellitus, Type 2

Keywords

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• HbA1c

  After 24 weeks

Secondary Outcomes (3)

• safety variables

• 8-point plasma glucose profile

• other glycemic variables

Interventions

biphasic insulin aspart DRUG

insulin glargine DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 Diabetes

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (73)

Novo Nordisk Investigational Site

Birmingham, Alabama, 35235, United States

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Tuscaloosa, Alabama, 35406, United States

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Vestavia Hills, Alabama, 35209, United States

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Searcy, Arkansas, 72143, United States

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Chula Vista, California, 91911, United States

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Fullerton, California, 92835, United States

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Orange, California, 92868, United States

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Orange, California, 92869, United States

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New Britain, Connecticut, 06050, United States

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Aventura, Florida, 33180, United States

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Chiefland, Florida, 32626, United States

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Fort Myers, Florida, 33907, United States

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Jacksonville, Florida, 32208, United States

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Melbourne, Florida, 32901, United States

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Ocala, Florida, 34471, United States

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Plantation, Florida, 33324, United States

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Atlanta, Georgia, 30303, United States

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Atlanta, Georgia, 30339, United States

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Boise, Idaho, 83702, United States

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Chicago, Illinois, 60607, United States

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New Albany, Indiana, 47150, United States

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Des Moines, Iowa, 50314, United States

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Overland Park, Kansas, 66209, United States

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Topeka, Kansas, 66606, United States

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Baton Rouge, Louisiana, 70808, United States

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Baltimore, Maryland, 21204, United States

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Springfield, Massachusetts, 01107, United States

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Chesterfield, Missouri, 63017, United States

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St Louis, Missouri, 63017, United States

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St Louis, Missouri, 63141, United States

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Omaha, Nebraska, 68114, United States

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Las Vegas, Nevada, 89119-6100, United States

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Cherry Hill, New Jersey, 08034, United States

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Lawrenceville, New Jersey, 08648, United States

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Plainsboro, New Jersey, 08536, United States

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New Hyde Park, New York, 11042, United States

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Staten Island, New York, 10305, United States

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Syracuse, New York, 13210, United States

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Greensboro, North Carolina, 27408, United States

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Dayton, Ohio, 45406, United States

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Dayton, Ohio, 45439, United States

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Kettering, Ohio, 45429, United States

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Clinton, Oklahoma, 73601, United States

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Tulsa, Oklahoma, 74104, United States

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Eugene, Oregon, 97401, United States

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Portland, Oregon, 97239, United States

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Salem, Oregon, 97302, United States

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Lancaster, Pennsylvania, 17601, United States

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Melrose Park, Pennsylvania, 19027, United States

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Norristown, Pennsylvania, 19401, United States

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West Reading, Pennsylvania, 19611, United States

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Greer, South Carolina, 29651, United States

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Memphis, Tennessee, 38115, United States

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Arlington, Texas, 76014, United States

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Dallas, Texas, 75208, United States

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Dallas, Texas, 75230, United States

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Dallas, Texas, 75231, United States

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Dallas, Texas, 75246, United States

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Dallas, Texas, 75390-8858, United States

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Houston, Texas, 77030, United States

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Lewisville, Texas, 75067, United States

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Midland, Texas, 79707, United States

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Plano, Texas, 75074, United States

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Plano, Texas, 75093, United States

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San Antonio, Texas, 78229, United States

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Ogden, Utah, 84403, United States

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Newport News, Virginia, 23606, United States

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Richmond, Virginia, 23249, United States

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Warrenton, Virginia, 20186, United States

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Bellevue, Washington, 98004, United States

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Milwaukee, Wisconsin, 53209, United States

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Manatí, 00674, Puerto Rico

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Santurce, 00907, Puerto Rico

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Related Publications (4)

• 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.

  PMID: 20713345 RESULT

• 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.

  PMID: 21741089 RESULT

• 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.

  PMID: 22509859 RESULT

• 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.

  PMID: 19210140 DERIVED

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Interventions

insulin aspart, insulin aspart protamine drug combination 30:70; Insulin Glargine

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2004
• First Posted: December 1, 2004
• Study Start: January 1, 2005
• Primary Completion: November 1, 2006
• Study Completion: November 1, 2006
• Last Updated: January 11, 2017

Record last verified: 2017-01

Locations

US (71); PR (2)