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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00700830
First received: June 18, 2008
Last updated: August 13, 2014
Last verified: December 2013
  Purpose

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • HbA1c [ Time Frame: after 12 weeks (3 months) AND after 24 weeks (6 months) ] [ Designated as safety issue: No ]
  • FBG (Fasting Blood Glucose) [ Time Frame: Monthly average for each month, and average of the past quarter ] [ Designated as safety issue: No ]
  • Weight [ Time Frame: after 12 weeks (3 months) AND after 24 weeks (6 months) ] [ Designated as safety issue: No ]

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®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Type 2 diabetes insulin naive patients

Criteria

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
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: NCT00700830

Locations
Algeria
Algiers, Algeria, 16035
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: NCT00700830     History of Changes
Other Study ID Numbers: NN304-3571
Study First Received: June 18, 2008
Last Updated: August 13, 2014
Health Authority: Algeria: Ministry of Health

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

ClinicalTrials.gov processed this record on September 18, 2014