Efficacy of Biphasic Insulin Aspart 30 in Type 2 Diabetics Failing on OADs (1-2-3)

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00791895
First received: November 13, 2008
Last updated: October 28, 2013
Last verified: October 2013
  Purpose

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 Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: biphasic insulin aspart 30
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Percentage of subjects achieving HbA1c below 6.5% [ Time Frame: after 16, 32 and 48 weeks, respectively ] [ Designated as safety issue: No ]

Enrollment: 102
Study Start Date: June 2003
Study Completion Date: November 2004
Arms Assigned Interventions
Experimental: A Drug: biphasic insulin aspart 30
Treat-to-target dose titration scheme
Other Names:
  • BIASP
  • NovoLog® Mix 70/30
  • NovoMix®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00791895

Locations
United States, Arizona
Novo Nordisk Clinical Trial Call Center
Phoenix, Arizona, United States, 85006
United States, California
Novo Nordisk Clinical Trial Call Center
La Jolla, California, United States, 92093-0831
United States, Florida
Novo Nordisk Clinical Trial Call Center
Deland, Florida, United States, 32720
United States, Nebraska
Novo Nordisk Clinical Trial Call Center
Omaha, Nebraska, United States, 68114
United States, New York
Novo Nordisk Clinical Trial Call Center
Albany, New York, United States, 12206
United States, Ohio
Novo Nordisk Clinical Trial Call Center
Cleveland, Ohio, United States, 44115
United States, Oregon
Novo Nordisk Clinical Trial Call Center
Medford, Oregon, United States, 97504
United States, Tennessee
Novo Nordisk Clinical Trial Call Center
Memphis, Tennessee, United States, 38119
United States, Texas
Novo Nordisk Clinical Trial Call Center
Dallas, Texas, United States, 75231
Novo Nordisk Clinical Trial Call Center
Houston, Texas, United States, 77030
United States, Utah
Novo Nordisk Clinical Trial Call Center
Ogden, Utah, United States, 84403
United States, Washington
Novo Nordisk Clinical Trial Call Center
Renton, Washington, United States, 98057
United States, Wisconsin
Novo Nordisk Clinical Trial Call Center
Milwaukee, Wisconsin, United States, 53209
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Elizabeth Hillier Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00791895     History of Changes
Other Study ID Numbers: BIASP-2174
Study First Received: November 13, 2008
Last Updated: October 28, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin aspart, insulin aspart protamine drug combination 30:70
Insulin
Insulin Aspart
Biphasic Insulins
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014