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

NCT00671008 | Completed

• 1 other identifier: NN304-1964
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Glycaemic control as measured by HbA1c

  After 24 weeks

Secondary Outcomes (5)

• Percentage of subjects to reach HbA1c below 7.0% and =6.5%

  After 24 weeks

• Percentage of subjects on once vs twice daily injections of Levemir® or NovoMix® 30

  After 24 weeks

• The effect on glycamic control as measured by FPG

  After 24 weeks

• The effect on glycamic control as measured by PG profile

  After 24 weeks

• Change in body weight

  After 24 weeks

Study Arms (2)

A

Drug: biphasic insulin aspart 30

B

Drug: insulin detemir

Interventions

biphasic insulin aspart 30 DRUG

Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

Also known as: NovoMix® 30

A

insulin detemir DRUG

Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

B

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Type 1 and Type 2 Diabetes Mellitus

You may qualify if:

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

You may not qualify if:

• Current treatment with NovoMix® 30 or Levemir®

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Unknown Facility

Sarajevo, Bosnia and Herzegovina

Location

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Interventions

insulin aspart, insulin aspart protamine drug combination 30:70; Insulin Detemir

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2008
• First Posted: May 2, 2008
• Study Start: December 1, 2007
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: January 2, 2024

Record last verified: 2023-12

Locations

BO (1)