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

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ClinicalTrials.gov Identifier: NCT00665093
Recruitment Status : Completed
First Posted : April 23, 2008
Last Update Posted : January 9, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
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 or disease Intervention/treatment
Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Drug: biphasic insulin aspart 30 Drug: insulin detemir

Study Type : Observational
Actual Enrollment : 1569 participants
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
Study Start Date : May 2007
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. HbA1c [ Time Frame: at 24 weeks ]

Secondary Outcome Measures :
  1. FPG, PG profile, weight, % of subjects on target [ Time Frame: at 24 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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®

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00665093


Locations
Macedonia, The Former Yugoslav Republic of
Novo Nordisk Investigational Site
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

Additional Information:
Publications of Results:
Milenkovic T. Significant Improvements in Glycemic Control with BIAsp 30 in Clinical Reality: Experience from clinical practice in Macedonia. ADA American Diabetes Association 2009; Country: USA City: New Orleans

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00665093     History of Changes
Other Study ID Numbers: BIASP-1894
First Posted: April 23, 2008    Key Record Dates
Last Update Posted: January 9, 2017
Last Verified: January 2017

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 Aspart
Insulin Detemir
Biphasic Insulins
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs