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Observational Study to Evaluate the Safety and Efficacy of Levemir® in Type 2 Diabetes (IDEALS)

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ClinicalTrials.gov Identifier: NCT00700830
Recruitment Status : Completed
First Posted : June 19, 2008
Last Update Posted : August 15, 2014
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This study is conducted in Africa. The aim of this study is to assess the safety and efficacy of Levemir® treatment for insulin naive patients with type 2 diabetes under normal clinical practice conditions in Algeria.

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

Study Type : Observational
Actual Enrollment : 1976 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Assessment of Safety and Efficacy of Levemir® (Insulin Detemir) Treatment for Insulin Naive Patients With Type 2 Diabetes Mellitus
Study Start Date : January 2008
Primary Completion Date : September 2009
Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
A Drug: insulin detemir
Initial dosage and the following dosages will be prescribed by the physician as a result of a normal clinical evaluation
Other Name: Levemir®

Primary Outcome Measures :
  1. Assessment the incidence of the Serious Adverse Events including the major Hypoglycaemia. [ Time Frame: During study ]

Secondary Outcome Measures :
  1. HbA1c [ Time Frame: after 12 weeks (3 months) AND after 24 weeks (6 months) ]
  2. FBG (Fasting Blood Glucose) [ Time Frame: Monthly average for each month, and average of the past quarter ]
  3. Weight [ Time Frame: after 12 weeks (3 months) AND after 24 weeks (6 months) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Type 2 diabetes insulin naive patients

Inclusion Criteria:

  • Informed consent obtained before any trial-related activities
  • Type 2 diabetes
  • HbA1c between 7-9%
  • Insulin naive
  • Inadequate control with oral antidiabetics therapy as judged by investigator

Exclusion Criteria:

  • Patients with type 1 diabetes
  • Hypersensitivity to Levemir® or to any of the excipients
  • Pregnancy, or desire of pregnancy within next 6 months
  • HbA1c greater than or equal to 9%
  • Known or suspected allergy to the trial product or to any of the excipients
  • Subjects who are unlikely to comply with protocol

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): NCT00700830

Algiers, Algeria, 16035
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00700830     History of Changes
Other Study ID Numbers: NN304-3571
First Posted: June 19, 2008    Key Record Dates
Last Update Posted: August 15, 2014
Last Verified: December 2013

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin Detemir
Hypoglycemic Agents
Physiological Effects of Drugs