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Observational Study to Evaluate Safety of Levemir® in Type 1 and Type 2 Diabetes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00700765
First Posted: June 19, 2008
Last Update Posted: October 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose
This study is conducted in Asia. The aim of this observational study is to evaluate the incidence of adverse events while using Levemir® under normal clinical practice conditions.

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, Safety Study in Subjects Using Levemir® (Insulin Detemir) for the Treatment of Insulin Dependent Type 1 or Type 2 Diabetes Mellitus

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Incidence of serious adverse drug reactions (SADRs) [ Time Frame: during treatment ]
  • Major hypoglycaemic events [ Time Frame: during treatment ]

Secondary Outcome Measures:
  • Number of serious adverse events [ Time Frame: during treatment ]
  • Number of all adverse events [ Time Frame: during treatment ]
  • Number of all hypoglycaemic events [ Time Frame: the last 4 weeks of treatment ]
  • Weight changes [ Time Frame: after 12 weeks ]
  • HbA1c [ Time Frame: after 12 weeks and 26 weeks of treatment ]
  • Variability in fasting blood glucose (FBG) and average plasma glucose level [ Time Frame: after 12 weeks ]

Enrollment: 1531
Study Start Date: January 2008
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A Drug: insulin detemir
For study drug, start dose and frequency of administration to be prescribed by the physician as a result of normal clinical evaluation
Other Name: Levemir®

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Any subject with type 1 or type 2 diabetes who is prescribed insulin detemir at the physician's discretion
Criteria

Inclusion Criteria:

  • Type 1 or type 2 diabetes mellitus

Exclusion Criteria:

  • Subjects who are unlikely to comply with the protocol
  • Subjects who are currently being treated with Levemir®
  • Subjects who previously were enrolled into the study
  • Subjects with hypersensitivity to Levemir® or any of its excipients
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00700765


Locations
Indonesia
Novo Nordisk Investigational Site
Jakarta, Indonesia, 12520
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00700765     History of Changes
Other Study ID Numbers: NN304-3528
First Submitted: June 18, 2008
First Posted: June 19, 2008
Last Update Posted: October 28, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin Detemir
Hypoglycemic Agents
Physiological Effects of Drugs