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Basal Bolus of Insulin Aspart Including Insulin NPH and Biphasic Insulin Aspart in Type 2 Diabetes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00600626
First Posted: January 25, 2008
Last Update Posted: January 6, 2017
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.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose
This trial is conducted in Europe and Asia. The aim of this trial is to compare basal bolus treatment with insulin aspart and insulin NPH to biphasic insulin aspart treatment on blood glucose control in type 2 diabetes.

Condition Intervention Phase
Diabetes Diabetes Mellitus, Type 2 Drug: biphasic insulin aspart Drug: insulin NPH Drug: insulin aspart Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Basal Bolus Treatment With Insulin Aspart Including Insulin NPH and Biphasic Insulin Aspart in Type 2 Diabetes Mellitus

Resource links provided by NLM:


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

Primary Outcome Measures:
  • HbA1c [ Time Frame: after 4 months of treatment ]

Secondary Outcome Measures:
  • 8-point blood glucose profile
  • incidence of hypoglycaemic episodes
  • safety profiles
  • changes in body weight and vital signs

Enrollment: 394
Study Start Date: January 2004
Study Completion Date: July 2004
Primary Completion Date: July 2004 (Final data collection date for primary outcome measure)
  Eligibility

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
Criteria

Inclusion Criteria:

  • Type 2 diabetes
  • Currently treated with human insulin or insulin analogues for at least 3 months, with or without combination with OADs
  • HbA1c between 8.0-10.5%
  • Body mass index (BMI) below 35.0 kg/m2
  • Able and willing to perform self-monitoring of blood glucose

Exclusion Criteria:

  • Total daily insulin dose of 1.80 IU/kg or more
  • Known or suspected allergy to trial product or related products
  • Pregnancy, breast-feeding, the intention to become pregnant or judged not to be using adequate contraceptive measures
  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): NCT00600626


  Show 55 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00600626     History of Changes
Other Study ID Numbers: BIASP-1486
First Submitted: January 14, 2008
First Posted: January 25, 2008
Last Update Posted: January 6, 2017
Last Verified: January 2017

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
Isophane insulin, beef
Insulin
Insulin Aspart
Insulin, Long-Acting
Biphasic Insulins
Isophane Insulin, Human
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs