Observational Study to Evaluate the Safety While Using Levemir®

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00701155
First received: June 13, 2008
Last updated: July 24, 2012
Last verified: July 2012
  Purpose

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
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®

  Eligibility

Genders Eligible for Study:   Both
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00701155

Locations
Egypt
Giza, Egypt, 0020
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Sherif Waguih Novo Nordisk Egypt
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00701155     History of Changes
Other Study ID Numbers: NN304-1953
Study First Received: June 13, 2008
Last Updated: July 24, 2012
Health Authority: Egypt: Ministry of Health and Population

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 April 23, 2014