Observational Study of Safety and Tolerability of Levemir™ FlexPen™ (Insulin Detemir) in the Treatment of Type 1 and Type 2 Diabetes Mellitus

NCT00655200 | Completed

• 1 other identifier: NN304-3525
• Study Type: observational
• Target: 2,286
• Locations: 1 country
• Sites: 1

Brief Summary

This study is conducted in Asia. The aim of this observational study is to evaluate the safety and tolerability of Levemir™ FlexPen™ (Insulin Detemir) in the treatment of Filipino patients with Type 1 and Type 2 Diabetes Mellitus.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Safety profile of Insulin Detemir among Filipino patients

  3 months follow-up visit

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™

A

Eligibility Criteria

• Age: 0 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Type 1 and Type 2 Diabetes

You may qualify if:

• Patients diagnosed with Type 1 or Type 2 Diabetes Mellitus.
• Newly diagnosed insulin naive patients
• Patients currently on human insulin or on basal insulin
• Patients prescribed with Levemir™ FlexPen™ (Insulin Detemir) therapy
• Usage should be in accordance with the current prescribing information (See attached prescribing information)

You may not qualify if:

• Previous history of hypersensitivity to Insulin Detemir (Levemir™) and its excipients (See attached prescribing information)
• Contraindications and warnings specified in the current prescribing information (See attached prescribing information)
• Pregnant women, those planning to become pregnant, or women who are breastfeeding
• Patients who are already on human premix or premix analogue (unless they are going to be shifted to basal-bolus therapy)
• Children below 6 years old

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Unknown Facility

Manila, 1605, Philippines

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

Study Record Dates

• First Submitted: April 4, 2008
• First Posted: April 9, 2008
• Study Start: February 1, 2008
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: November 22, 2023

Record last verified: 2023-11

Locations

PH (1)