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

NCT03960814 | Completed

• 3 other identifiers: NN304-4528U1111-1233-0930EUPAS29708
• Study Type: observational
• Target: 12,847
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

• Age at all cause death or censoring

  Years

  Observation period 2004 - 2018

• Age at death of cardiovascular disease

  Years

  Observation period 2004 - 2018

Study Arms (1)

Cohort 1

New users of basal insulins glargine and detemir

Drug: Insulin detemir

Interventions

Insulin detemir 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.

Cohort 1

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

New users of basal insulins glargine and detemir

You may qualify if:

• 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

You may not qualify if:

• Diagnosis of type 1 diabetes

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Bagsværd, 2880, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Detemir

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Clinical Reporting Anchor and Disclosure (1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2019
• First Posted: May 23, 2019
• Study Start: May 21, 2019
• Primary Completion: June 7, 2019
• Study Completion: June 7, 2019
• Last Updated: July 18, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share

Locations

DK (1)