Observational Study to Evaluate the Safety While Using Levemir®

NCT00701155 | Completed

• 1 other identifier: NN304-1953
• Study Type: observational
• Target: 3,593
• Locations: 1 country
• Sites: 1

Brief Summary

This study is conducted in Africa. The aim of this observational study is to evaluate the incidence of serious adverse drug reactions while using insulin Levemir® under normal clinical practice conditions in Egypt.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Incidence of serious ADRs incl. major hypoglycemias

  after 24 weeks

Secondary Outcomes (7)

• Number of serious adverse events

  after 24 weeks

• Number of all adverse events

  after 24 weeks

• Weight changes

  after 24 weeks

• HbA1c

  after 24 weeks

• Subgroup analysis of hypoglycemias

  after 24 weeks

Study Arms (1)

A

Drug: insulin detemir

Interventions

insulin detemir DRUG

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

Also known as: Levemir®

A

Eligibility Criteria

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

Study Population

Type 1 or 2 diabetes patients

You may qualify if:

• After the physician decision has been made to use insulin detemir, any subject with Type 1 or Type 2 diabetes mellitus is eligible for the study, including newly-diagnosed subjects who have never received insulin or an insulin analogue before. The selection of the subjects will be at the discretion of the individual physician.

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 insulin detemir;
• Subjects who previously enrolled in this study
• Subjects with a hypersensitivity to insulin detemir or to any of the excipients
• Pregnancy, breast-feeding, the intention to become pregnant or judged not to be using adequate contraceptive measures. (Adequate contraceptive measures are an intrauterine device, oral contraceptives and barrier methods)

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Unknown Facility

Giza, 0020, Egypt

Location

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

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

Interventions

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: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2008
• First Posted: June 19, 2008
• Study Start: July 1, 2007
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: November 2, 2023

Record last verified: 2023-10

Locations

EG (1)