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

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ClinicalTrials.gov Identifier: NCT03960814
Recruitment Status : Not yet recruiting
First Posted : May 23, 2019
Last Update Posted : May 23, 2019
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

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

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Study Type : Observational
Estimated Enrollment : 10000 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
Estimated Study Start Date : May 21, 2019
Estimated Primary Completion Date : May 21, 2019
Estimated Study Completion Date : May 21, 2019

Resource links provided by the National Library of Medicine


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.




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



Information from the National Library of Medicine

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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

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


Contacts
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Contact: Novo Nordisk (+1) 866-867-7178 clinicaltrials@novonordisk.com

Locations
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Denmark
Novo Nordisk Investigational Site Not yet recruiting
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

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT03960814     History of Changes
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: May 23, 2019
Last Verified: May 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
Insulin, Globin Zinc
Insulin Glargine
Insulin Detemir
Hypoglycemic Agents
Physiological Effects of Drugs