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INITIATE Plus (INITiation of Insulin to Reach A1c TargEt) Study (INITIATE plus)

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ClinicalTrials.gov Identifier: NCT00101751
Recruitment Status : Completed
First Posted : January 13, 2005
Last Update Posted : October 17, 2014
Information provided by (Responsible Party):

Study Description
Brief Summary:
This trial is conducted in the United States of America (USA). The purpose of this study is to compare the effectiveness and safety of a biphasic insulin aspart standard titration regimen when coupled with dietary intervention to standard titration without dietary intervention.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4877 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of a Standard Titration Algorithm Coupled With a Conventional Dietary Intervention or Intensive Dietary Intervention Versus a Standard Titration Algorithm, Alone, in Patients With Type 2 Diabetes Initiating NovoLog® Mix 70/30 Therapy
Study Start Date : October 2004
Primary Completion Date : June 2006
Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. HbA1c and Incidence of hypoglycemia [ Time Frame: After 24 weeks of treatment ]

Secondary Outcome Measures :
  1. Postprandial glucose from 8-point SMBG spontaneously reported adverse events; any changes from baseline

Eligibility Criteria

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Type 2 Diabetes
Contacts and Locations

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): NCT00101751

United States, New Jersey
Novo Nordisk Clinical Trial Call Center
Princeton, New Jersey, United States, 08540
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00101751     History of Changes
Other Study ID Numbers: BIASP-2192
First Posted: January 13, 2005    Key Record Dates
Last Update Posted: October 17, 2014
Last Verified: October 2014

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin Aspart
Biphasic Insulins
Hypoglycemic Agents
Physiological Effects of Drugs