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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00655200
First received: April 4, 2008
Last updated: August 13, 2014
Last verified: November 2012
  Purpose

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.


Condition Intervention
Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Drug: insulin detemir

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study of Safety and Tolerability of Levemir™ FlexPen™ (Insulin Detemir) in the Treatment of Type 1 and Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Safety profile of Insulin Detemir among Filipino patients [ Time Frame: 3 months follow-up visit ] [ Designated as safety issue: No ]

Enrollment: 2286
Study Start Date: February 2008
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A Drug: insulin detemir
Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
Other Name: Levemir™

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with Type 1 and Type 2 Diabetes

Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00655200

Locations
Philippines
Manilla, Philippines, 1605
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00655200     History of Changes
Other Study ID Numbers: NN304-3525
Study First Received: April 4, 2008
Last Updated: August 13, 2014
Health Authority: Philippines: Bureau of Food and Drugs

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014