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

NCT ID: NCT03960814

Last Updated: 2019-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

12847 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-21

Study Completion Date

2019-06-07

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Cohort 1

New users of basal insulins glargine and detemir

Insulin detemir

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Reporting Anchor and Disclosure (1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Bagsværd, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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U1111-1233-0930

Identifier Type: OTHER

Identifier Source: secondary_id

EUPAS29708

Identifier Type: REGISTRY

Identifier Source: secondary_id

NN304-4528

Identifier Type: -

Identifier Source: org_study_id

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