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NCT03960814 Clinical Trial

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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03960814
Other study ID # NN304-4528
Secondary ID U1111-1233-0930E
Status Completed
Phase
First received
Last updated
Start date May 21, 2019
Est. completion date June 7, 2019

Study information
Verified date July 2019
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 12847
Est. completion date June 7, 2019
Est. primary completion date June 7, 2019
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Denmark Novo Nordisk Investigational Site Bagsværd

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Age at all cause death or censoring Years Observation period 2004 - 2018
Primary Age at death of cardiovascular disease Years Observation period 2004 - 2018
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