Observational Safety Study in Subjects Using Levemir® (Insulin Detemir) for the Treatment of Type 2 Diabetes Mellitus

NCT00709475 | Completed

• 1 other identifier: NN304-3551
• Study Type: observational
• Target: 747
• Locations: 1 country
• Sites: 1

Brief Summary

This study is conducted in Asia. The aim of this observational study is to evaluate the incidence of serious adverse drug reactions while using insulin detemir under normal clinical practice conditions in the Gulf countries

Conditions

Diabetes; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Incidence of serious adverse drug reactions, evaluated via number of major hypoglycaemic events

  For the duration of the study (32 weeks)

Secondary Outcomes (6)

• Number of serious adverse events

  For the duration of the study

• Number of all adverse events

  For the duration of the study

• Number of all - daytime and nocturnal - hypoglycaemic events

  In the 4 weeks before baseline compared to 4 weeks before interim and final visits

• Weight changes compared to baseline

  At the end of the study

• HbA1c compared to baseline

  At the end of the study

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 normal clinical evaluation

Also known as: Levemir®, NN304

A

Eligibility Criteria

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

Study Population

Type 2 diabetic patients

You may qualify if:

• After the physician decision has been made to use 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. 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 or studies related to NovoMix 30;
• Subjects with a hypersensitivity to insulin detemir or to any of the excipients;
• Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 8 months.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Riyadh, 3542, Saudi Arabia

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

Study Record Dates

• First Submitted: June 30, 2008
• First Posted: July 3, 2008
• Study Start: May 1, 2008
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: October 28, 2016

Record last verified: 2016-10

Locations

SA (1)