Evaluation of Levemir® for the Treatment of Type 1 and 2 Diabetes (PREDICTIVE™)

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00655044
First received: April 4, 2008
Last updated: July 24, 2012
Last verified: July 2012
  Purpose

This study is conducted in Europe. The aim of this observational study is to evaluate the incidence of serious adverse drug reactions while using 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: Observational Model: Case Control
Official Title: Observational, Safety Study in Subjects Using Levemir® (Insulin Detemir) for the Treatment of Type 1 or Type 2 Diabetes Mellitus

Resource links provided by NLM:


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

Primary Outcome Measures:
  • HbA1C [ Time Frame: after 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety [ Time Frame: during treatment ] [ Designated as safety issue: Yes ]

Enrollment: 3753
Study Start Date: May 2007
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Type 1 and type 2 diabetes patients Drug: insulin detemir
Safety and effectiveness data collection in connection with the use of drug Levemir in daily clinical practice.
Other Names:
  • Levemir®
  • NN304

  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 1 and type 2 diabetes patients

Criteria

Inclusion Criteria:

  • Type 1 diabetes
  • Type 2 diabetes
  • Candidates of use of a basal insulin as part of their diabetes regimen

Exclusion Criteria:

  • Unwilling to adhere to therapy or follow up
  • Pregnancy
  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: NCT00655044

Locations
Russian Federation
Moscow, Russian Federation, 119330
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Akeel Ballan, RN/MSc/BAcom Novo Nordisk Russia
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00655044     History of Changes
Other Study ID Numbers: NN304-3514
Study First Received: April 4, 2008
Last Updated: July 24, 2012
Health Authority: Russia: Federal Service for Control of Health Care and Social Development

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 10, 2014