Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Observational Study
. 2020 Dec;8(2):e001830.
doi: 10.1136/bmjdrc-2020-001830.

Real-world clinical outcomes following treatment intensification with GLP-1 RA, OADs or insulin in patients with type 2 diabetes on two oral agents (PATHWAY 2-OADs)

Cyrus Desouza  1 , Andreas R Kirk  2 , Kamal K Mangla  3 , Michael L Wolden  2 , Ildiko Lingvay  4
Affiliations
Observational Study

Real-world clinical outcomes following treatment intensification with GLP-1 RA, OADs or insulin in patients with type 2 diabetes on two oral agents (PATHWAY 2-OADs)

Cyrus Desouza et al. BMJ Open Diabetes Res Care. 2020 Dec.

Abstract

Introduction: Most patients with type 2 diabetes require sequential addition of glucose-lowering agents to maintain long-term glycemic control. In this retrospective, observational study, we compared intensification with a glucagon-like peptide-1 receptor agonist (GLP-1 RA), oral antidiabetic drugs (OADs), and insulin in patients receiving two OADs, using US electronic health records and claims data.

Research design and methods: For inclusion, patients in the IBM MarketScan Explorys database were required to have claims for two different OADs in the 180-day baseline period and ≥1 claim for a different OAD/GLP-1 RA/insulin at index date (treatment intensification). Changes in glycated hemoglobin (HbA1c) and weight from baseline were assessed at 180 days postindex. Patients were propensity score-matched by baseline characteristics and exact-matched by HbA1c category (HbA1c cohort and weight/composite outcomes cohort) and body mass index (BMI) category (weight/composite outcomes cohort only) to obtain balanced treatment arms. The primary endpoint was the percentage of patients reaching target HbA1c <7% (53 mmol/mol).

Results: Significantly more patients intensifying with a GLP-1 RA achieved HbA1c <7% than those receiving OAD(s) (OR: 1.35; 95% CI 1.03 to 1.77; p=0.032) or insulin (OR: 1.77; 95% CI 1.27 to 2.47; p<0.001). GLP-1 RAs were also associated with a significantly greater chance of not gaining weight; significantly greater HbA1c and weight decreases from baseline; and a significantly greater chance of HbA1c <7%, no weight gain and discontinuation of ≥1 baseline OAD (composite outcome), compared with OAD(s) or insulin.

Conclusions: In propensity score-matched cohorts, GLP-1 RAs demonstrated significant benefits for both glycemic control and weight management over additional OAD(s) or insulin, respectively, indicating that they may represent the optimal choice at these points in the treatment pathway.

Keywords: blood glucose; glucagon-like peptide 1; observational study; weight loss.

PubMed Disclaimer

Conflict of interest statement

Competing interests: CD has performed consultancy for AstraZeneca, Bayer AG and Novo Nordisk A/S. ARK and MLW are employees of, and shareholders in, Novo Nordisk A/S. KKM is an employee of Novo Nordisk Global Service Centre India, which is part of Novo Nordisk A/S. IL has performed consultancy for AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Eli Lilly and Company, Intarcia Therapeutics, Janssen Pharmaceuticals, MannKind Corporation, Novo Nordisk A/S, Sanofi, TARGET PharmaSolutions and Valeritas.

Figures

Figure 1
Figure 1
Study design. Index date was defined as the date of treatment intensification. GLP-1 RA, glucagon-like peptide-1 receptor agonist; HbA1c, glycated hemoglobin; OAD, oral antidiabetic drug.
Figure 2
Figure 2
OR for GLP-1 RAs versus OAD(s) or insulin for single outcomes (A, B) and composite outcomes (C, D). GLP-1 RA, glucagon-like peptide-1 receptor agonist; HbA1c, glycated hemoglobin; OAD, oral antidiabetic drug.
See this image and copyright information in PMC

References

    1. ADVANCE Collaborative Group, Patel A, MacMahon S, et al. . Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes. N Engl J Med 2008;358:2560–72. 10.1056/NEJMoa0802987 - DOI - PubMed
    1. Zoungas S, Patel A, Chalmers J, et al. . Severe hypoglycemia and risks of vascular events and death. N Engl J Med 2010;363:1410–8. 10.1056/NEJMoa1003795 - DOI - PubMed
    1. American Diabetes Association 8. Obesity management for the treatment of type 2 diabetes: standards of medical care in diabetes-2020. Diabetes Care 2020;43:S89–97. 10.2337/dc20-S008 - DOI - PubMed
    1. American Diabetes Association 9. Pharmacologic approaches to glycemic treatment: standards of medical care in diabetes-2020. Diabetes Care 2020;43:S98–110. 10.2337/dc20-S009 - DOI - PubMed
    1. Pantalone KM, Misra-Hebert AD, Hobbs TM, et al. . Intensification patterns and the probability of HbA1c goal attainment in Type 2 diabetes mellitus: real-world evidence for the concept of 'intensification inertia'. Diabet Med 2020;37:1114–24. 10.1111/dme.13900 - DOI - PubMed

Publication types