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A Study of All-Cause and Cardiovascular Mortality in Type 2 Diabetes Patients Using Basal Insulin Detemir and Glargine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03960814
Recruitment Status : Completed
First Posted : May 23, 2019
Last Update Posted : July 18, 2019
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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Brief Summary:
This study will examine the influence of the basal insulins detemir and glargine on risk of cardiovascular death and death from all causes in patients treated by their general practitioner in United Kingdom (UK). The data for this study will be drawn from the Clinical Practice Research Datalink (CPRD) Register.

Condition or disease Intervention/treatment
Diabetes Mellitus, Type 2 Drug: Insulin detemir

Study Design
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Study Type : Observational
Actual Enrollment : 12847 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Retrospective Cohort Study of All-Cause and Cardiovascular Mortality in Type 2 Diabetes Patients Using Basal Insulin Detemir and Glargine
Actual Study Start Date : May 21, 2019
Actual Primary Completion Date : June 7, 2019
Actual Study Completion Date : June 7, 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Cohort 1
New users of basal insulins glargine and detemir
 Drug: Insulin detemir
No treatment will be given to the patients in relation to this study. Patients have been included in this study because they have been treated with insulin glargine or detemir prior to study initiation (2004 - 2018) and according to routine clinical practice at that time. The decision to initiate treatment with commercially available insulin detemir and glargine has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study.


Outcome Measures
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Primary Outcome Measures :
  1. Age at all cause death or censoring [ Time Frame: Observation period 2004 - 2018 ]
    Years

  2. Age at death of cardiovascular disease [ Time Frame: Observation period 2004 - 2018 ]
    Years


Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
New users of basal insulins glargine and detemir
Criteria

Inclusion Criteria:

  • Diagnosis (ever) of type 2 diabetes
  • Prescription (ever) of basal insulins glargine or detemir
  • Insulin-naïve until initiation of basal insulins glargine or detemir
  • Aged 40 years or older at start of observation period

Exclusion Criteria:

  • Diagnosis of type 1 diabetes
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03960814


Locations
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Denmark
Novo Nordisk Investigational Site
Bagsværd, Denmark, 2880
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Clinical Reporting Anchor and Disclosure (1452) Novo Nordisk A/S
More Information
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT03960814    
Other Study ID Numbers: NN304-4528
U1111-1233-0930 ( Other Identifier: World Health Organization (WHO) )
EUPAS29708 ( Registry Identifier: EU PAS Register )
First Posted: May 23, 2019    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
URL: http://novonordisk-trials.com

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Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Insulin Detemir
Hypoglycemic Agents
Physiological Effects of Drugs