Observational Study to Evaluate the Safety and Efficacy of Levemir® in Type 2 Diabetes

NCT00700830 | Completed

• 1 other identifier: NN304-3571
• Study Type: observational
• Target: 1,976
• Locations: 1 country
• Sites: 1

Brief Summary

This study is conducted in Africa. The aim of this study is to assess the safety and efficacy of Levemir® treatment for insulin naive patients with type 2 diabetes under normal clinical practice conditions in Algeria.

Conditions

Diabetes; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Assessment the incidence of the Serious Adverse Events including the major Hypoglycaemia.

  During study

Secondary Outcomes (3)

• HbA1c

  after 12 weeks (3 months) AND after 24 weeks (6 months)

• FBG (Fasting Blood Glucose)

  Monthly average for each month, and average of the past quarter

• Weight

  after 12 weeks (3 months) AND after 24 weeks (6 months)

Study Arms (1)

A

Drug: insulin detemir

Interventions

insulin detemir DRUG

Initial dosage and the following dosages will be prescribed by the physician as a result of a normal 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 2 diabetes insulin naive patients

You may qualify if:

• Informed consent obtained before any trial-related activities
• Type 2 diabetes
• HbA1c between 7-9%
• Insulin naive
• Inadequate control with oral antidiabetics therapy as judged by investigator

You may not qualify if:

• Patients with type 1 diabetes
• Hypersensitivity to Levemir® or to any of the excipients
• Pregnancy, or desire of pregnancy within next 6 months
• HbA1c greater than or equal to 9%
• Known or suspected allergy to the trial product or to any of the excipients
• Subjects who are unlikely to comply with protocol

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Unknown Facility

Algiers, 16035, Algeria

Location

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Interventions

Insulin Detemir

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: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2008
• First Posted: June 19, 2008
• Study Start: January 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: August 15, 2014

Record last verified: 2013-12

Locations

AL (1)