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Observational Study to Evaluate the Safety While Using Levemir®

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ClinicalTrials.gov Identifier: NCT00701155
Recruitment Status : Completed
First Posted : June 19, 2008
Last Update Posted : February 19, 2016
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This study is conducted in Africa. The aim of this observational study is to evaluate the incidence of serious adverse drug reactions while using insulin Levemir® under normal clinical practice conditions in Egypt.

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

Study Type : Observational
Actual Enrollment : 3593 participants
Time Perspective: Prospective
Official Title: Observational, Safety Study in Subjects Using Insulin Detemir for the Treatment of Insulin Dependent Type 1 or Type 2 Diabetes Mellitus
Study Start Date : July 2007
Primary Completion Date : March 2008
Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
A Drug: insulin detemir
Start dose and frequency to be prescribed by the physician as a result of the actual clinical evaluation
Other Name: Levemir®



Primary Outcome Measures :
  1. Incidence of serious ADRs incl. major hypoglycemias [ Time Frame: after 24 weeks ]

Secondary Outcome Measures :
  1. Number of serious adverse events [ Time Frame: after 24 weeks ]
  2. Number of all adverse events [ Time Frame: after 24 weeks ]
  3. Weight changes [ Time Frame: after 24 weeks ]
  4. HbA1c [ Time Frame: after 24 weeks ]
  5. Subgroup analysis of hypoglycemias [ Time Frame: after 24 weeks ]
  6. Number of all hypoglycemic events [ Time Frame: in the 4 weeks preceding the visits at 12 weeks and 24 weeks. ]
  7. Variability in fasting Blood Sugar and average plasma glucose levels [ Time Frame: after 24 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
Type 1 or 2 diabetes patients
Criteria

Inclusion Criteria:

  • After the physician decision has been made to use insulin detemir, any subject with Type 1 or Type 2 diabetes mellitus is eligible for the study, including newly-diagnosed subjects who have never received insulin or an insulin analogue before. The selection of the subjects will be at the discretion of the individual physician.

Exclusion Criteria:

  • Subjects who are unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for the final visit;
  • Subjects currently being treated with insulin detemir;
  • Subjects who previously enrolled in this study
  • Subjects with a hypersensitivity to insulin detemir or to any of the excipients
  • Pregnancy, breast-feeding, the intention to become pregnant or judged not to be using adequate contraceptive measures. (Adequate contraceptive measures are an intrauterine device, oral contraceptives and barrier methods)

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): NCT00701155


Locations
Egypt
Giza, Egypt, 0020
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: NCT00701155     History of Changes
Other Study ID Numbers: NN304-1953
First Posted: June 19, 2008    Key Record Dates
Last Update Posted: February 19, 2016
Last Verified: February 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