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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 (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00665093
First received: April 22, 2008
Last updated: March 3, 2016
Last verified: March 2016
  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:


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

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

Ages Eligible for Study:   Child, Adult, Senior
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
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: NCT00665093

Locations
Macedonia, The Former Yugoslav Republic of
Skopje, Macedonia, The Former Yugoslav Republic of, MK-1000
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: NCT00665093     History of Changes
Other Study ID Numbers: BIASP-1894 
Study First Received: April 22, 2008
Last Updated: March 3, 2016
Health Authority: Macedonia, The Former Yugoslav Republic of: Drug Agency, Ministry of Health

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin aspart, insulin aspart protamine drug combination 30:70
Insulin
Insulin Detemir
Insulin Aspart
Insulin, Isophane
Biphasic Insulins
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 26, 2016