Observational Study of Patients Using NovoMix® 30 or Levemir® for Treatment of Type 1 or Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00671008
First received: April 30, 2008
Last updated: July 24, 2012
Last verified: July 2012
  Purpose

This trial is conducted in Europe.

The aim of this observational study is to evaluate the glycaemic control in patients with type 1 or 2 diabetes using NovoMix® 30 or Levemir® under normal clinical practice conditions.


Condition Intervention
Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Drug: biphasic insulin aspart 30
Drug: insulin detemir

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Efficacy of Glycaemic Control of Biphasic Insulin Aspart (NovoMix® 30) or Insulin Detemir (Levemir®) in Patients With Type 1 or 2 Diabetes Mellitus

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Glycaemic control as measured by HbA1c [ 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% [ Time Frame: After 24 weeks ] [ Designated as safety issue: No ]
  • Percentage of subjects on once vs twice daily injections of Levemir® or NovoMix® 30 [ Time Frame: After 24 weeks ] [ Designated as safety issue: No ]
  • The effect on glycamic control as measured by FPG [ Time Frame: After 24 weeks ] [ Designated as safety issue: No ]
  • The effect on glycamic control as measured by PG profile [ Time Frame: After 24 weeks ] [ Designated as safety issue: No ]
  • Change in body weight [ Time Frame: After 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 400
Study Start Date: December 2007
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A Drug: biphasic insulin aspart 30
Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
Other Name: NovoMix® 30
B Drug: insulin detemir
Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Type 1 and Type 2 Diabetes Mellitus

Criteria

Inclusion Criteria:

  • Patients with Type 1 or Type 2 diabetes, including newly diagnosed
  • Age: Levemir® above 6 years
  • Age: Novomix® above 18 years

Exclusion Criteria:

  • Current treatment with NovoMix® 30 or Levemir®
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00671008

Locations
Bosnia and Herzegovina
Sarajevo, Bosnia and Herzegovina
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Enisa Secerovic Walton, MD Novo Nordisk A/S, Bosnia & Herzegov (RO)
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00671008     History of Changes
Other Study ID Numbers: NN304-1964
Study First Received: April 30, 2008
Last Updated: July 24, 2012
Health Authority: Bosnia and Herzegovina: Federal Ministry of Health

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin aspart
Insulin
Insulin, Long-Acting
Insulin, NPH
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014