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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: NCT00671008
Recruitment Status : Completed
First Posted : May 2, 2008
Last Update Posted : March 3, 2016
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 : 400 participants
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
Study Start Date : December 2007
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. Glycaemic control as measured by HbA1c [ Time Frame: After 24 weeks ]

Secondary Outcome Measures :
  1. Percentage of subjects to reach HbA1c below 7.0% and =6.5% [ Time Frame: After 24 weeks ]
  2. Percentage of subjects on once vs twice daily injections of Levemir® or NovoMix® 30 [ Time Frame: After 24 weeks ]
  3. The effect on glycamic control as measured by FPG [ Time Frame: After 24 weeks ]
  4. The effect on glycamic control as measured by PG profile [ Time Frame: After 24 weeks ]
  5. Change in body weight [ Time Frame: After 24 weeks ]


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Ages Eligible for Study:   Child, Adult, Senior
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:

  • 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®

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): NCT00671008


Locations
Bosnia and Herzegovina
Sarajevo, Bosnia and Herzegovina
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00671008     History of Changes
Other Study ID Numbers: NN304-1964
First Posted: May 2, 2008    Key Record Dates
Last Update Posted: March 3, 2016
Last Verified: March 2016

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