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
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 April 22, 2014