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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00670722
First received: April 30, 2008
Last updated: June 26, 2012
Last verified: June 2012
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • HbA1c after switch from human insulin to modern insulin treatment [ Time Frame: After 24 weeks ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Postprandial glycaemic control as measured by PPG [ Time Frame: After 12 and 24 weeks ] [ Designated as safety issue: No ]
  • Glucose variability as measured by FPG [ Time Frame: After 12 and 24 weeks ] [ Designated as safety issue: No ]
  • Insulin dose and number of injections [ Time Frame: After 12 and 24 weeks ] [ Designated as safety issue: No ]
  • Body weight [ Time Frame: After 12 and 24 weeks ] [ Designated as safety issue: No ]
  • Number of hypoglycaemic events [ Time Frame: During treatment ] [ Designated as safety issue: Yes ]
  • Number of adverse drug reactions (ADR) [ Time Frame: After 12 and 24 weeks ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00670722

Locations
Czech Republic
Prague, Czech Republic, 16000
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Wlodzimierz M. Kolaczynski, MD Novo Nordisk Region Europe A/S
Study Director: Karel Rychna, MD Novo Nordisk s.r.o
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00670722     History of Changes
Other Study ID Numbers: NN304-3517
Study First Received: April 30, 2008
Last Updated: June 26, 2012
Health Authority: Czech Republic: State Institute for Drug Control

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin aspart
 Insulin
Insulin, Long-Acting
Insulin, NPH
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013