An Observational Study on Efficacy and Safety in Subjects Using Levemir® for the Treatment of Insulin Dependent Type 1 or Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00738153
First received: August 19, 2008
Last updated: August 13, 2014
Last verified: August 2014
  Purpose

This observational study is conducted in Africa. The aim of this observational study is to evaluate the efficacy and the incidence of serious adverse drug reactions while using insulin 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: Time Perspective: Prospective
Official Title: Efficacy and Safety Study of Levemir® (Insulin Detemir) to Treat Type 1 and 2 Diabetes Mellitus

Resource links provided by NLM:


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

Primary Outcome Measures:
  • The incidence of serious adverse drug reactions, including major hypoglycaemic events [ Time Frame: From baseline to 12 and 24 weeks of Levemir® therapy, respectively ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of serious adverse events [ Time Frame: From baseline to 12 and 24 weeks of Levemir® therapy, respectively ] [ Designated as safety issue: No ]
  • Number of all adverse events [ Time Frame: From baseline to 12 and 24 weeks of Levemir® therapy, respectively ] [ Designated as safety issue: No ]
  • Number of all hypoglycaemic events [ Time Frame: in the 4 weeks preceding the visits at 12 weeks and 24 weeks. ] [ Designated as safety issue: No ]
  • Weight changes [ Time Frame: at the end of study ] [ Designated as safety issue: No ]
  • HbA1c [ Time Frame: at the end of study ] [ Designated as safety issue: No ]
  • Sub -group analysis of hypo risk [ Time Frame: From baseline to 12 and 24 weeks of Levemir® therapy, respectively ] [ Designated as safety issue: No ]

Enrollment: 798
Study Start Date: June 2008
Study Completion Date: May 2009
Primary Completion Date: May 2009 (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 normal clinical evaluation
Other Name: Levemir®

  Eligibility

Ages Eligible for Study:   7 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Any subject with type 1 or type 2 diabetes is eligible for the study, including newly-diagnosed subjects who have never received insulin or an insulin analogue before

Criteria

Inclusion Criteria:

  • 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
  • Currently being treated with insulin detemir
  • Previously enrolled in this study
  • 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.
  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 ClinicalTrials.gov identifier: NCT00738153

Locations
Morocco
Casablanca, Morocco, 20000
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00738153     History of Changes
Other Study ID Numbers: NN304-3536
Study First Received: August 19, 2008
Last Updated: August 13, 2014
Health Authority: Morocco: Ministry of Health

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, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014