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

This study has been completed.
Information provided by:
Novo Nordisk A/S Identifier:
First received: January 12, 2005
Last updated: October 21, 2013
Last verified: October 2013

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 Intervention Phase
Diabetes Mellitus, Type 2
Drug: biphasic insulin aspart
Behavioral: dietary regimen
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

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

Primary Outcome Measures:
  • HbA1c and Incidence of hypoglycemia [ Time Frame: After 24 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Postprandial glucose from 8-point SMBG spontaneously reported adverse events; any changes from baseline [ Designated as safety issue: No ]

Enrollment: 4877
Study Start Date: October 2004
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Type 2 Diabetes
  Contacts and Locations
Please refer to this study by its identifier: 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: Rogelio Braceras, MD Novo Nordisk A/S
  More Information

Additional Information:
No publications provided by Novo Nordisk A/S

Additional publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00101751     History of Changes
Other Study ID Numbers: BIASP-2192
Study First Received: January 12, 2005
Last Updated: October 21, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin aspart
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions processed this record on April 16, 2014