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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: June 19, 2008
Last Update Posted: August 15, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
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 Intervention
Diabetes Diabetes Mellitus, Type 2 Drug: insulin detemir

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

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

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

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

Enrollment: 1976
Study Start Date: January 2008
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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®


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
  Contacts and Locations
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
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00700830     History of Changes
Other Study ID Numbers: NN304-3571
First Submitted: June 18, 2008
First Posted: June 19, 2008
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