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Clinical Outcomes of Exenatide Versus Basal Insulin

NCT02987348 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 18000

Last updated 2017-03-29

No results posted yet for this study

Summary

This is a retrospective cohort study based on Clinical Practice Research Datalink (CPRD) database analysis to compare therapy effectiveness, and cost between exenatide and basal insulin in patients with type 2 diabetes.

Type 2 diabetes (T2DM) is a chronic condition characterized by elevated blood sugar levels (hyperglycaemia) that can result in an increased risk of a variety of conditions including heart disease, strokes, kidney failure, blindness and amputation. Whilst initially patients may control their blood sugar by lifestyle modification (diet and exercise), ultimately most will require therapeutic intervention with regimens that increase in complexity as T2DM progresses. Exenatide is a relatively recent anti-diabetic drug which is known to lead to weight loss as well as improved blood glucose control. It has also been associated with reduced heart attacks and strokes. In this study CPRD database will be used to compare outcomes for patients prescribed exenatide compared with those prescribed insulin; a more established treatment for T2DM. In particular changes from baseline in blood sugar control and weight will be considered as the primary outcomes. As the choice to treat with exenatide or insulin will be related to patient characteristics which may in themselves be associated with the outcomes of the study we aim to match study patients on some of these key variables and adjust for others in our analysis.

Conditions

Interventions

DRUG

exenatide once weekly

patients received exenatide once weekly treatment under their standard care, no intervention was given by the study investigator

DRUG

exenatide twice daily

patients with exenatide twice daily treatment under their standard care, no intervention was given by the study investigator.

DRUG

basal insulin

patients with basal insulin treatment under their standard care, no intervention was given by the study investigator

Sponsors & Collaborators

Principal Investigators

  • Craig Currie, Ph.D · Pharmatelligence, UK

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02987348 on ClinicalTrials.gov