Back to resultsSafety of Insulin Detemir for the Treatment of Insulin Dependent Type 1 or Type 2 Diabetes Mellitus (PREDICTIVE™)
Primary Purpose
Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
insulin detemir
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Insulin detemir
Arm Description
Outcomes
Primary Outcome Measures
Incidence of serious adverse drug reactions (SADRs) including major hypoglycaemic events
Secondary Outcome Measures
Number of adverse events (all and serious)
Number of all hypoglycaemic events
Change in weight
HbA1c (glycosylated haemoglobin)
Treatment satisfaction as assessed by Insulin Treatment Satisfaction Questionnaire (ITSQ-22)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01709929
Brief Title
Safety of Insulin Detemir for the Treatment of Insulin Dependent Type 1 or Type 2 Diabetes Mellitus
Acronym
PREDICTIVE™
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
April 2006 (Actual)
Study Completion Date
April 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2287 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Insulin detemir
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
insulin detemir
Intervention Description
Administered subcutaneously (s.c., under the skin). Dose individually adjusted.
Primary Outcome Measure Information:
Title
Incidence of serious adverse drug reactions (SADRs) including major hypoglycaemic events
Secondary Outcome Measure Information:
Title
Number of adverse events (all and serious)
Title
Number of all hypoglycaemic events
Title
Change in weight
Title
HbA1c (glycosylated haemoglobin)
Title
Treatment satisfaction as assessed by Insulin Treatment Satisfaction Questionnaire (ITSQ-22)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
City
Mississauga
ZIP/Postal Code
L4W 4XI
Country
Canada
12. IPD Sharing Statement
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
Safety of Insulin Detemir for the Treatment of Insulin Dependent Type 1 or Type 2 Diabetes Mellitus
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