Safety of NovoMix® 30 or Levemir® for Treatment of Type 2 Diabetics in Macedonia

NCT00842894 | Completed

• 1 other identifier: NN304-3716
• Study Type: observational
• Target: 3,421
• Locations: 1 country
• Sites: 1

Brief Summary

This study is conducted in Europe. The aim of this observational study is to investigate the incidence of serious adverse drug reactions when using NovoMix® 30 (biphasic insulin aspart 30) or Levemir® (insulin detemir) for treatment of type 2 diabetes mellitus under normal clinical practice conditions in Macedonia.

Conditions

Diabetes; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Incidence of serious adverse drug reactions (SADRs)

  after 26 weeks

Secondary Outcomes (7)

• Number of all minor hypoglycaemic events

  during 4 weeks preceding each visit

• Number of all major hypoglycaemic events

  during 13 weeks preceding each visit

• HbA1c

  after 26 weeks

• Percentage of subjects to reach HbA1c below 7.0%

  after 13 weeks and 26 weeks

• The effect on glycaemic control as measured by FPG (fasting plasma glucose)

  after 13 weeks and 26 weeks

Study Arms (2)

Insulin detemir

Drug: insulin detemir

Biphasic insulin aspart 30

Drug: biphasic insulin aspart 30

Interventions

insulin detemir DRUG

Safety and effectiveness data collection in connection with the use of the drug.

Also known as: NN304, Levemir®

Insulin detemir

biphasic insulin aspart 30 DRUG

Safety and effectiveness data collection in connection with the use of the drug in daily clinical practice.

Biphasic insulin aspart 30

Eligibility Criteria

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

Study Population

Patients from speciality practice settings who have been deemed appropriate to receive biphasic insulin aspart 30 or insulin detemir as new treatment and as part of routine out-patient care by the prescribing physician.

You may qualify if:

• After the physician decision has been made to use biphasic insulin aspart 30 or insulin detemir therapy, any subject with Type 2 diabetes is eligible for the study, including newly-diagnosed subjects who have never received insulin or an insulin analogue before.Particular attention should be paid to the drug interactions that are listed within the product label

You may not qualify if:

• Subjects who are unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for the final visit
• Subjects currently being treated with biphasic insulin aspart 30 or insulin detemir
• Subjects who were previously enrolled in this study
• Subjects with a hypersensitivity to biphasic insulin aspart 30 or insulin detemir or to any of the excipients
• Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 6 months

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Unknown Facility

Skopje, MK-1000, North Macedonia

Location

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Interventions

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

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine 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: February 11, 2009
• First Posted: February 12, 2009
• Study Start: May 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: August 15, 2014

Record last verified: 2012-11

Locations

NO (1)