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Biphasic Insulin Aspart 30 in Type 2 Diabetes Failing OAD Therapy (INITIATE)

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: NCT00598793
Recruitment Status : Completed
First Posted : January 23, 2008
Last Update Posted : January 9, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This trial is conducted in the United States of America (USA). The aim of this trial is to compare biphasic insulin aspart 30 plus metformin in a standard injection regimen to a standard dosing of insulin glargine plus metformin on blood glucose control in subjects with type 2 diabetes who are insulin naive and failing OAD therapy.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Drug: biphasic insulin aspart Drug: insulin glargine Drug: metformin Drug: pioglitazone Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 242 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Biphasic Insulin Aspart 70/30 + Metformin Compared to Insulin Glargine + Metformin in Type 2 Diabetes Failing OAD Therapy
Study Start Date : November 2002
Actual Primary Completion Date : March 2004
Actual Study Completion Date : March 2004

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. HbA1c [ Time Frame: after 28 weeks of treatment ]

Secondary Outcome Measures :
  1. Postprandial glucose by 8-point SMBG
  2. Number of subjects achieving HbA1c below 7%
  3. Number of hypoglycemic episodes and adverse events
  4. Weight change
  5. Insulin dose


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Insulin naive Type 2 diabetes
  • Currently treated with OADs alone or combined with other treatment for at least 3 months
  • BMI below 40 kg/m2 and body weight below 125 kg
  • HbA1c greater than or equal to 8%

Exclusion Criteria:

  • Inability to tolerate metformin or contradictions to its use
  • Pregnant, breastfeeding or intention of becoming pregnant
  • Allergy to any of the trial products
  • Inability or unwillingness to perform SMBG

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): NCT00598793


Locations
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United States, California
Novo Nordisk Investigational Site
Concord, California, United States, 94520
Novo Nordisk Investigational Site
Los Angeles, California, United States, 90057
Novo Nordisk Investigational Site
Walnut Creek, California, United States, 94598
United States, Florida
Novo Nordisk Investigational Site
Melbourne, Florida, United States, 32901
Novo Nordisk Investigational Site
Melbourne, Florida, United States, 32935
Novo Nordisk Investigational Site
West Palm Beach, Florida, United States, 33401
United States, Georgia
Novo Nordisk Investigational Site
Atlanta, Georgia, United States, 30318
Novo Nordisk Investigational Site
Marietta, Georgia, United States, 30067
United States, Idaho
Novo Nordisk Investigational Site
Idaho Falls, Idaho, United States, 83404-7596
United States, Illinois
Novo Nordisk Investigational Site
Chicago, Illinois, United States, 60607
United States, Kentucky
Novo Nordisk Investigational Site
Lexington, Kentucky, United States, 40504-2681
United States, New York
Novo Nordisk Investigational Site
Buffalo, New York, United States, 14209
United States, North Carolina
Novo Nordisk Investigational Site
Asheville, North Carolina, United States, 28803
United States, Ohio
Novo Nordisk Investigational Site
Canton, Ohio, United States, 44708
Novo Nordisk Investigational Site
Columbus, Ohio, United States, 43203
United States, Oregon
Novo Nordisk Investigational Site
Medford, Oregon, United States, 97504
United States, Pennsylvania
Novo Nordisk Investigational Site
Hershey, Pennsylvania, United States, 17033
United States, South Carolina
Novo Nordisk Investigational Site
Greer, South Carolina, United States, 29651
United States, Texas
Novo Nordisk Investigational Site
Dallas, Texas, United States, 75230
Novo Nordisk Investigational Site
Dallas, Texas, United States, 75231
Novo Nordisk Investigational Site
Dallas, Texas, United States, 75246
Novo Nordisk Investigational Site
Dallas, Texas, United States, 75390-8858
Novo Nordisk Investigational Site
Houston, Texas, United States, 77030
Novo Nordisk Investigational Site
Midland, Texas, United States, 79707
Novo Nordisk Investigational Site
San Antonio, Texas, United States, 78229
United States, Virginia
Novo Nordisk Investigational Site
Warrenton, Virginia, United States, 20186
United States, Washington
Novo Nordisk Investigational Site
Renton, Washington, United States, 98055
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Additional Information:
Publications of Results:

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00598793    
Other Study ID Numbers: BIASP-2163
First Posted: January 23, 2008    Key Record Dates
Last Update Posted: January 9, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Metformin
Insulin Glargine
Pioglitazone
Insulin Aspart
Biphasic Insulins
Hypoglycemic Agents
Physiological Effects of Drugs