Inadequate achievement in haemoglobin A1c and weight targets in adults with type 2 diabetes on once weekly glucagon-like peptide-1 receptor agonists therapy: a multi-variate analysis of UK primary care data

Study type
Protocol
Date of Approval
Study reference ID
23_002645
Lay Summary

Type 2 diabetes (T2D) is a common condition, characterised by high blood glucose levels and associated with long-term complications and significant health, social and economic burden.
Lowering blood glucose levels is an important target, as it has been shown to prevent complications in patients with T2D such as kidney events and heart attacks. Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are an established type of treatment which have been shown to reduce blood glucose levels with the added benefit of weight loss, while some such treatments also improve heart health by reducing the risk of heart attacks and strokes.

Currently, there are three GLP-1 RA treatments taken as a once weekly injection approved for use in the UK for the treatment of T2D; dulaglutide, semaglutide and exenatide. UK guidelines for the treatment of T2D set a target for blood glucose levels of <7% after 6 months of using a once weekly injectable GLP-1 RA treatment. International reports have also set weight loss targets of 5-15% to indicate a slowdown in the progression of the condition.
Little research has been carried out in the UK to understand if patients are achieving these set targets. Therefore, this study aims to address these gaps by describing the number of patients with T2D newly prescribed once weekly injectable GLP-1 RA treatment who achieve the blood glucose level and weight loss targets, and to assess the relationship between these reductions and patient demographic, health and treatment characteristics.

Technical Summary

Aim: To evaluate HbA1c target attainment and weight reduction after 6 months of once weekly injectable GLP-1 RA use in UK primary care clinical practice, and associated sociodemographic, clinical and treatment characteristics. This evidence will support physicians in making informed decisions regarding GLP-1 RA therapy to ultimately improve patients’ outcomes and quality of life.

Objectives: To describe, after 6 months of once weekly injectable GLP-1 RA therapy use, the proportion of patients i) achieving a HbA1c of <7%, ii) achieving weight loss of >0%, ≥5%, ≥10% or ≥15%, iii) achieving ≥1% HbA1c reduction and weight reduction of >0%, ≥5%, ≥10% or ≥15%, and iv) continuing GLP-1 RA therapy despite failing to achieve a ≥1% HbA1c reduction. We will also describe sociodemographic, clinical and treatments factors associated with target attainment/ reductions, as well as longer-term (12 and 18 months) HbA1c target attainment and weight reduction.

Exposures: T2D diagnostic code; once weekly injectable GLP-1 RA therapy

Outcomes: HbA1c targets; weight reduction, composite HbA1c and weight reduction; GLP-1 RA continuation despite HbA1c reduction <1%; sociodemographic, clinical and treatment characteristics

Methods: A retrospective cohort study of patients with T2D newly initiating once weekly injectable GLP-1 RA therapy between Jan-2020 and Nov-2021 (indexing period), using primary care data (CPRD Aurum). The first/earliest treatment prescription date of once weekly dulaglutide, subcutaneous semaglutide or exenatide within the indexing period will determine the index date. A minimum of 12 months pre-index and 6 months of follow-up (continuous index GLP-1 RA therapy use) are required for study inclusion. Patients prescribed any GLP-1 RAs up to 3 months prior to their index date will be excluded.

Data analysis: Analysis will be descriptive in nature. Relative frequencies and proportions/percentages will be reported for categorical variables. Count, mean, median, standard deviation, interquartile range, and minimum/maximum values will be reported for numeric variables.

Health Outcomes to be Measured

HbA1c target attainment (<7.0%, <7.5%); Weight reduction (>0%, ≥5%, ≥10%, ≥15%); Composite HbA1c (>1%) and weight (>0%, ≥5%, ≥10%, ≥15%) reduction measure; Once weekly injectable GLP-1 RA continuation despite HbA1c reduction <1%; sociodemographic, clinical and treatment characteristics.

Collaborators

Katrien Wijndaele - Chief Investigator - Eli Lilly and Company Ltd. (UK)
Monica Seif - Corresponding Applicant - Adelphi Real World
Antje Hottgenroth - Collaborator - Lilly Deutschland GmbH
Antonia Geneidat - Collaborator - Adelphi Real World
Joanne Webb - Collaborator - Eli Lilly & Co Ltd - US Headquarters
Kamlesh Khunti - Collaborator - University of Leicester
Kunal Gulati - Collaborator - Eli Lilly & Co - UK
Lill-Brith von Arx - Collaborator - Eli Lilly & Co - UK
Ramota Alaran - Collaborator - Adelphi Real World
Robert Wood - Collaborator - Adelphi Real World
Rosie Wild - Collaborator - Adelphi Real World
Thomas Jennison - Collaborator - Adelphi Real World

Linkages

Patient Level Index of Multiple Deprivation