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Initiation of Insulin Aspart in Type 2 Diabetes

This study has been completed.
Information provided by:
Novo Nordisk A/S Identifier:
First received: December 12, 2007
Last updated: June 5, 2012
Last verified: September 2011
This trial is conducted in Europe. The aim of this trial is to investigate if using insulin aspart as start therapy will improve the efficacy on daytime blood glucose cycle profile in subjects with type 2 diabetes.

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the Initiation of Insulin Treatment Using Insulin Aspart on Blood Glucose Profile in Type 2 Diabetes Mellitus

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Blood glucose value [ Time Frame: at 5 pm in a daytime blood glucose cycle profile ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluation of 24-hour blood glucose cycle [ Designated as safety issue: No ]
  • HbA1c [ Designated as safety issue: No ]
  • Hypoglycaemic episodes [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: February 2003
Study Completion Date: February 2004
Primary Completion Date: February 2004 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Type 2 diabetes for at least 3 years
  • HbA1c greater than 8.0%
  • Body Mass Index (BMI) below 40.0 kg/m2
  • Inadequate treatment with diet and OADs
  • Never received treatment with insulin

Exclusion Criteria:

  • Type 1 diabetes
  • Known or suspected allergy to investigational 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 identifier: NCT00572806

MONTPELLIER cedex 5, France, 34295
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Christine Hamonou Novo Nordisk Pharmaceutique SAS
  More Information

Additional Information:
Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S Identifier: NCT00572806     History of Changes
Other Study ID Numbers: ANA-1501 
Study First Received: December 12, 2007
Last Updated: June 5, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin degludec, insulin aspart drug combination
Insulin Aspart
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on January 18, 2017