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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:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00655200
First received: April 4, 2008
Last updated: July 24, 2012
Last verified: July 2012
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

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

Enrollment: 3299
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00655200

Locations
Philippines
Manilla, Philippines, 1605
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Dixie Pritzel C. Calpatura Novo Nordisk
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Public Access to Clinical Trials, 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: July 24, 2012
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
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013