Skip to main content
OpenTrials
Completed

NCT Number: NCT00700830

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Algiers, 16035, Algeria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

insulin detemir

Drug

Initial dosage and the following dosages will be prescribed by the physician as a result of a normal clinical evaluation

Other names: Levemir®

Primary outcomes

  1. Assessment the incidence of the Serious Adverse Events including the major Hypoglycaemia.

    Time frame: During study

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Assessment of Safety and Efficacy of Levemir® (Insulin Detemir) Treatment for Insulin Naive Patients With Type 2 Diabetes Mellitus

Acronym: IDEALS

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jun 19, 2008
Registry last updated
Aug 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.