Safety of Insulin Detemir for the Treatment of Insulin Dependent Type 1 or Type 2 Diabetes Mellitus (PREDICTIVE™)

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01709929
First received: October 16, 2012
Last updated: NA
Last verified: October 2012
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Drug: insulin detemir
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Incidence of serious adverse drug reactions (SADRs) including major hypoglycaemic events [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of adverse events (all and serious) [ Designated as safety issue: No ]
  • Number of all hypoglycaemic events [ Designated as safety issue: No ]
  • Change in weight [ Designated as safety issue: No ]
  • HbA1c (glycosylated haemoglobin) [ Designated as safety issue: No ]
  • Treatment satisfaction as assessed by Insulin Treatment Satisfaction Questionnaire (ITSQ-22) [ Designated as safety issue: No ]

Enrollment: 2287
Study Start Date: October 2005
Study Completion Date: April 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Insulin detemir Drug: insulin detemir
Administered subcutaneously (s.c., under the skin). Dose individually adjusted.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT01709929

Locations
Canada
Mississauga, Canada, L4W 4XI
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Angele Mongol Novo Nordisk Canada Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01709929     History of Changes
Other Study ID Numbers: NN304-1713
Study First Received: October 16, 2012
Last Updated: October 16, 2012
Health Authority: Canada: Health Canada

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, Globin Zinc
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014