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Observational Study to Evaluate the Safety While Using Levemir®

This study has been completed.
Information provided by (Responsible Party):
Novo Nordisk A/S Identifier:
First received: June 13, 2008
Last updated: February 18, 2016
Last verified: February 2016
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 Intervention
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Drug: insulin detemir

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Incidence of serious ADRs incl. major hypoglycemias [ Time Frame: after 24 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of serious adverse events [ Time Frame: after 24 weeks ] [ Designated as safety issue: Yes ]
  • Number of all adverse events [ Time Frame: after 24 weeks ] [ Designated as safety issue: Yes ]
  • Weight changes [ Time Frame: after 24 weeks ] [ Designated as safety issue: No ]
  • HbA1c [ Time Frame: after 24 weeks ] [ Designated as safety issue: No ]
  • Subgroup analysis of hypoglycemias [ Time Frame: after 24 weeks ] [ Designated as safety issue: No ]
  • Number of all hypoglycemic events [ Time Frame: in the 4 weeks preceding the visits at 12 weeks and 24 weeks. ] [ Designated as safety issue: Yes ]
  • Variability in fasting Blood Sugar and average plasma glucose levels [ Time Frame: after 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 3593
Study Start Date: July 2007
Study Completion Date: March 2008
Primary Completion Date: March 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 actual clinical evaluation
Other Name: Levemir®


Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Type 1 or 2 diabetes patients

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)
  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 identifier: NCT00701155

Giza, Egypt, 0020
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S Identifier: NCT00701155     History of Changes
Other Study ID Numbers: NN304-1953 
Study First Received: June 13, 2008
Last Updated: February 18, 2016
Health Authority: Egypt: Ministry of Health and Population

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 Detemir
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on October 21, 2016