- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01709929
Safety of Insulin Detemir for the Treatment of Insulin Dependent Type 1 or Type 2 Diabetes Mellitus (PREDICTIVE™)
March 2, 2016 updated by: Novo Nordisk A/S
A Multicentre, Open Label, Nonrandomised, Safety Study in Subjects Using Insulin Detemir for the Treatment of Insulin Dependent Type 1 or Type 2 Diabetes Mellitus
This trial is conducted in North America.
The aim of this trial is to evaluate the safety of insulin detemir for the treatment of diabetes.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
2287
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Mississauga, Canada, L4W 4XI
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosed with type 1 or type 2 diabetes
- Using a basal/bolus insulin regimen
Exclusion Criteria:
- Subjects who are unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for the final visit
- Subjects who previously enrolled in this study
- Subjects with a hypersensitivity to insulin detemir or to any of the excipients
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Insulin detemir
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Administered subcutaneously (s.c., under the skin).
Dose individually adjusted.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Incidence of serious adverse drug reactions (SADRs) including major hypoglycaemic events
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Secondary Outcome Measures
Outcome Measure |
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HbA1c (glycosylated haemoglobin)
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Change in weight
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Number of adverse events (all and serious)
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Number of all hypoglycaemic events
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Treatment satisfaction as assessed by Insulin Treatment Satisfaction Questionnaire (ITSQ-22)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2005
Primary Completion (Actual)
April 1, 2006
Study Completion (Actual)
April 1, 2006
Study Registration Dates
First Submitted
October 16, 2012
First Submitted That Met QC Criteria
October 16, 2012
First Posted (Estimate)
October 18, 2012
Study Record Updates
Last Update Posted (Estimate)
March 3, 2016
Last Update Submitted That Met QC Criteria
March 2, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NN304-1713
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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