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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00670722
First received: April 30, 2008
Last updated: June 26, 2012
Last verified: June 2012
  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 ] [ 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
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 ClinicalTrials.gov identifier: NCT00670722

Locations
Czech Republic
Prague, Czech Republic, 16000
Sponsors and Collaborators
Novo Nordisk A/S
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:
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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Biphasic Insulins
Insulin
Insulin Aspart
Insulin aspart, insulin aspart protamine drug combination 30:70
Insulin, Globin Zinc
Insulin, Isophane
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014