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Observational Study on Blood Glucose Control in Patients With Diabetes Using Modern Insulin

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00670722
First Posted: May 2, 2008
Last Update Posted: October 28, 2016
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 study is conducted in Europe. An observational study evaluating the blood glucose control in patients using a modern insulin: NovoRapid®, NovoMix® 30 or Levemir® for treatment of Type 2 diabetes mellitus in Czech Republic.

Condition Intervention
Diabetes Diabetes Mellitus, Type 2 Drug: insulin aspart Drug: insulin detemir Drug: biphasic insulin aspart 30

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study on Evaluation of Glycaemic Control in Patients Using a Modern Insulin - NovoRapid® (Insulin Aspart), NovoMix® 30 (Biphasic Insulin Aspart 30) or Levemir® (Insulin Detemir) for Treatment of Type 2 Diabetes Mellitus

Resource links provided by NLM:


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

Primary Outcome Measures:
  • HbA1c after switch from human insulin to modern insulin treatment [ Time Frame: After 24 weeks ]

Secondary Outcome Measures:
  • Percentage of subjects to reach HbA1c below 7.0% and = 6.5% at approximately 12 weeks and 24 weeks of treatment [ Time Frame: After 12 and 24 weeks ]
  • Postprandial glycaemic control as measured by PPG [ Time Frame: After 12 and 24 weeks ]
  • Glucose variability as measured by FPG [ Time Frame: After 12 and 24 weeks ]
  • Insulin dose and number of injections [ Time Frame: After 12 and 24 weeks ]
  • Body weight [ Time Frame: After 12 and 24 weeks ]
  • Number of hypoglycaemic events [ Time Frame: During treatment ]
  • Number of adverse drug reactions (ADR) [ Time Frame: After 12 and 24 weeks ]

Enrollment: 6500
Study Start Date: January 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A Drug: insulin aspart
Intervention at the discretion of the physician
Other Name: NovoRapid®
B Drug: insulin detemir
Intervention at the discretion of the physician
C Drug: biphasic insulin aspart 30
Intervention at the discretion of the physician
D Drug: insulin aspart
Intervention at the discretion of the physician
Other Name: NovoRapid®
Drug: insulin detemir
Intervention at the discretion of the physician

  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
Sampling Method:   Non-Probability Sample
Study Population
Patients with Type 2 diabetes
Criteria

Inclusion Criteria:

  • Type 2 diabetes
  • Current treatment with human soluble insulin, insulin NPH or premixed human insulin
  • The selection of the subjects will be at the discretion of the individual physician

Exclusion Criteria:

  • Current treatment with insulin aspart, insulin detemir or biphasic insulin aspart 30
  • Previous enrolment in this study
  • Hypersensitivity to insulin aspart, insulin detemir or biphasic insulin aspart 30 or to any of the excipients.
  • Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 6 months and considered to be treated by biphasic insulin aspart 30 or insulin detemir
  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): NCT00670722


Locations
Czech Republic
Novo Nordisk Investigational Site
Prague, Czech Republic, 16000
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00670722     History of Changes
Other Study ID Numbers: NN304-3517
First Submitted: April 30, 2008
First Posted: May 2, 2008
Last Update Posted: October 28, 2016
Last Verified: October 2016

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 aspart protamine drug combination 30:70
Insulin
Insulin Aspart
Insulin, Long-Acting
Insulin Detemir
Biphasic Insulins
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs


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