Clinical Outcomes of Exenatide Versus Basal Insulin

NCT02987348 | Completed DMC

• 1 other identifier: D5551R00010
• Study Type: observational
• Target: 18,000
• Locations: 1 country
• Sites: 1

Brief 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

Type 2 Diabetes

Keywords

type 2 diabetes

Outcome Measures

Primary Outcomes (3)

• Changes from baseline in HbA1c (%)

  Changes in HbA1c at 6 months, 12 months and 24 months after initiation of the treatment with exenatide and basal insulin will be calculated and compared.

  6, 12 and 24 months

• Changes from baseline in weight (kg)

  Changes in weight at 6 months, 12 months and 24 months after initiation of the treatment with exenatide and basal insulin will be calculated and compared.

  6, 12 and 24 months

• Changes from baseline in composite outcomes of HbA1c<=7.0% and weight reduction

  Changes in composite outcome of HbA1c\<=7.0% and any weight reduction or HbA1c\<=7.0% and weight reduction\>=5% at 6 months, 12 months and 24 months after initiation of the treatment with exenatide and basal insulin will be calculated and compared.

  6, 12 and 24 months

Secondary Outcomes (1)

• Health care utilization

  12 months

Study Arms (4)

exenatide once weekly

type 2 diabetes patients who were first prescribed with exenatide once weekly in the index period identified from CPRD database of UK primary care

Drug: exenatide once weekly

basal insulin_1

type 2 diabetes patients who were first prescribed with basal insulin in the index period and matched with exenatide once weekly group identified from CPRD database of UK primary care

Drug: basal insulin

exenatide twice daily

type 2 diabetes patients who were first prescribed with exenatide twice daily in the index period identified from CPRD database of UK primary care

Drug: exenatide twice daily

basal insulin_2

type 2 diabetes patients who were first prescribed with basal insulin in the index period and matched with exenatide twice daily group identified from CPRD database of UK primary care

Drug: basal insulin

Interventions

exenatide once weekly DRUG

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

Also known as: long_acting glucagon-like peptide-1 receptor agonist

exenatide once weekly

exenatide twice daily DRUG

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

Also known as: short-acting glucagon-like peptide-1 receptor agonist

exenatide twice daily

basal insulin DRUG

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

Also known as: long-acting insulins

basal insulin_1; basal insulin_2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is a non-interventional study based on secondary data analysis. Patients received treatment under their standard care, no intervention was given by the study investigator. Patients will be identified and included in the study if they were defined by CPRD as being of acceptable research quality and classified as having type 2 diabetes who initiated exenatide or basal insulin as monotherapy or in combination with one or more other oral glucose-lowering therapies between January 2009 and December 2014. Exenatide once weekly (Bydureon) and exenatide twice daily (Byetta) are both investigated, and compared with matched basal insulin cohort. Patients will be excluded if they had received prior injectable diabetes therapy and had less than 90 days continuous exposure to the study drugs.

You may qualify if:

• Type 2 diabetic patients who initiated therapy with exenatide or basal insulin between 2009 and 2014.

You may not qualify if:

• prior injectable diabetes therapy
• less than 365 days between the latter of the patient's CPRD registration date/practice up-to-standard date and study index date.
• less than 90 days continuous exposure to Exenatide or basal insulin

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Pharmatelligence

Cardiff, CF14 3QZ, United Kingdom

Location

Related Publications (1)

• Holden SE, Morgan CL, Qiao Q, Jenkins-Jones S, Berni ER, Currie CJ. Healthcare resource utilization and related financial costs associated with glucose lowering with either exenatide or basal insulin: A retrospective cohort study. Diabetes Obes Metab. 2017 Aug;19(8):1097-1105. doi: 10.1111/dom.12916. Epub 2017 Mar 31.

  PMID: 28218819 BACKGROUND

Related Links

• CSR Synopsis

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Study Officials

• Craig Currie, Ph.D

  Pharmatelligence, UK

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 24, 2016
• First Posted: December 8, 2016
• Study Start: June 30, 2015
• Primary Completion: June 30, 2015
• Study Completion: June 30, 2015
• Last Updated: March 29, 2017

Record last verified: 2017-03

Locations

GB (1)