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

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ClinicalTrials.gov Identifier: NCT00700765
Recruitment Status : Completed
First Posted : June 19, 2008
Last Update Posted : October 28, 2016
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
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 or disease Intervention/treatment
Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Drug: insulin detemir

Study Type : Observational
Actual Enrollment : 1531 participants
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
Study Start Date : January 2008
Primary Completion Date : July 2008
Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
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®



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

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


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

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

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00700765     History of Changes
Other Study ID Numbers: NN304-3528
First Posted: June 19, 2008    Key Record Dates
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