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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00791895
Recruitment Status : Completed
First Posted : November 17, 2008
Last Update Posted : February 24, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Drug: biphasic insulin aspart 30 Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: NovoLog® Mix 70/30 (Biphasic Insulin Aspart 70/30) Titrate-To-Target: An Observational Study of the Efficacy of NovoLog® Mix 70/30 in Patients With Type 2 Diabetes Mellitus Not Achieving Glycemic Targets on OADs With / Without Once Daily Basal Insulin Therapy
Actual Study Start Date : June 26, 2003
Actual Primary Completion Date : October 31, 2004
Actual Study Completion Date : November 29, 2004

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Arms and Interventions
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Arm Intervention/treatment
Experimental: A Drug: biphasic insulin aspart 30
Treat-to-target dose titration scheme
Other Names:
  • BIASP
  • NovoLog® Mix 70/30
  • NovoMix®


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of subjects achieving HbA1c below 6.5% [ Time Frame: after 16, 32 and 48 weeks, respectively ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00791895


Locations
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United States, Arizona
Novo Nordisk Investigational Site
Phoenix, Arizona, United States, 85006
United States, California
Novo Nordisk Investigational Site
La Jolla, California, United States, 92093-0694
Novo Nordisk Investigational Site
La Jolla, California, United States, 92093-0831
United States, Florida
Novo Nordisk Investigational Site
Deland, Florida, United States, 32720
United States, Kansas
Novo Nordisk Investigational Site
Wichita, Kansas, United States, 67205
United States, Nebraska
Novo Nordisk Investigational Site
Omaha, Nebraska, United States, 68114
United States, New York
Novo Nordisk Investigational Site
Albany, New York, United States, 12206
United States, Ohio
Novo Nordisk Investigational Site
Cleveland, Ohio, United States, 44115
United States, Oregon
Novo Nordisk Investigational Site
Medford, Oregon, United States, 97504
United States, Tennessee
Novo Nordisk Investigational Site
Memphis, Tennessee, United States, 38119
United States, Texas
Novo Nordisk Investigational Site
Dallas, Texas, United States, 75231
Novo Nordisk Investigational Site
Houston, Texas, United States, 77030
United States, Utah
Novo Nordisk Investigational Site
Ogden, Utah, United States, 84403
United States, Washington
Novo Nordisk Investigational Site
Renton, Washington, United States, 98057
United States, Wisconsin
Novo Nordisk Investigational Site
Milwaukee, Wisconsin, United States, 53209
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information
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Additional Information:

Publications of Results:

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00791895    
Other Study ID Numbers: BIASP-2174
First Posted: November 17, 2008    Key Record Dates
Last Update Posted: February 24, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Insulin Aspart
Biphasic Insulins
Insulin aspart, insulin aspart protamine drug combination 30:70
Hypoglycemic Agents
Physiological Effects of Drugs