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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
ClinicalTrials.gov Identifier:
NCT00665093
First received: April 22, 2008
Last updated: May 24, 2012
Last verified: May 2012
History of Changes
  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: A Prospective, Multicentre, Open Label, Non-controlled, Observational, 24-week Study in Patients Using NovoMix® 30 (Biphasic Insulin Aspart 30) or Levemir® (Insulin Detemir) for Treatment of Type 1 or Type 2 Diabetes Mellitus in Macedonia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • HbA1c [ Time Frame: at 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • FPG, PG profile, weight, % of subjects on target [ Time Frame: at 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 1569
Study Start Date: May 2007
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A Drug: biphasic insulin aspart 30
Start dose and frequency prescribed by the physician as a result of a normal clinical evaluation
Other Names:
  • NovoMix® 30
  • BIASP
B Drug: insulin detemir
Start dose and frequency prescribed by the physician as a result of a 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:

  • Levemir® above 6 yrs
  • NovoMix® 30 above 18 yrs
  • Patients with Type 1 or Type 2 diabetes, including newly diagnosed

Exclusion Criteria:

  • Current treatment with NovoMix® 30 or Levemir®
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00665093

Locations
Macedonia, The Former Yugoslav Republic of
Skopje, Macedonia, The Former Yugoslav Republic of, MK-1000
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Ivica Smokovski, MD Novo Nordisk A/S Representative Office Macedonia
  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: NCT00665093     History of Changes
Other Study ID Numbers: BIASP-1894
Study First Received: April 22, 2008
Last Updated: May 24, 2012
Health Authority: Macedonia, The Former Yugoslav Republic of: Drug Agency, 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 May 16, 2013